Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant features the capability to correct implant mis-angulation. Four unique angle options offer flexibility to achieve the desired path of insertion for denture stabilization, even when implants are placed in narrow, resorbed ridges. The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization.This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments. Available in two styles One-Piece, 0° Micro Head and Two-Piece angle correction. Angle correction available in 0°, 5°, 11°, 17°, 23° and 30°. Intended for For surgical implantation in the maxillary or mandibular arch to support dental restorations such as artificial teeth, in order to restore the patient’s chewing function. Intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems.
STERNGOLD DENTAL LLC
901526
Not in Commercial Distribution

  • 00841549108365 ()


  • Dental implant suprastructure, permanent, preformed
Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant features the capability to correct implant mis-angulation. Four unique angle options offer flexibility to achieve the desired path of insertion for denture stabilization, even when implants are placed in narrow, resorbed ridges. The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization.This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments. Available in two styles One-Piece, 0° Micro Head and Two-Piece angle correction. Angle correction available in 0°, 5°, 11°, 17°, 23° and 30°. Intended for For surgical implantation in the maxillary or mandibular arch to support dental restorations such as artificial teeth, in order to restore the patient’s chewing function. Intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems.
STERNGOLD DENTAL LLC
901525
Not in Commercial Distribution

  • 00841549108358 ()


  • Dental implant suprastructure, permanent, preformed
Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant features the capability to correct implant mis-angulation. Four unique angle options offer flexibility to achieve the desired path of insertion for denture stabilization, even when implants are placed in narrow, resorbed ridges. The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization.This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments. Available in two styles One-Piece, 0° Micro Head and Two-Piece angle correction. Angle correction available in 0°, 5°, 11°, 17°, 23° and 30°. Intended for For surgical implantation in the maxillary or mandibular arch to support dental restorations such as artificial teeth, in order to restore the patient’s chewing function. Intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems.
STERNGOLD DENTAL LLC
901524
Not in Commercial Distribution

  • 00841549108341 ()


  • Dental implant suprastructure, permanent, preformed
Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant features the capability to correct implant mis-angulation. Four unique angle options offer flexibility to achieve the desired path of insertion for denture stabilization, even when implants are placed in narrow, resorbed ridges. The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization.This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments. Available in two styles One-Piece, 0° Micro Head and Two-Piece angle correction. Angle correction available in 0°, 5°, 11°, 17°, 23° and 30°. Intended for For surgical implantation in the maxillary or mandibular arch to support dental restorations such as artificial teeth, in order to restore the patient’s chewing function. Intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems.
STERNGOLD DENTAL LLC
901523
Not in Commercial Distribution

  • 00841549108334 ()


  • Dental implant suprastructure, permanent, preformed
Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant features the capability to correct implant misangulation. Four unique angle options offer flexibility to achieve the desired path of insertion for denture stabilization, even when implants are placed in narrow, resorbed ridges. The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization.This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments. Available in two styles One-Piece, 0° Micro Head and Two-Piece angle correction. Angle correction available in 0°, 5°, 11°, 17°, 23° and 30°. Intended for For surgical implantation in the maxillary or mandibular arch to support dental restorations such as artificial teeth, in order to restore the patient’s chewing function. Intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems.
STERNGOLD DENTAL LLC
901522
Not in Commercial Distribution

  • 00841549108327 ()


  • Dental implant suprastructure, permanent, preformed
Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant features the capability to correct implant mis-angulation. Four unique angle options offer flexibility to achieve the desired path of insertion for denture stabilization, even when implants are placed in narrow, resorbed ridges. The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization.This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments. Available in two styles One-Piece, 0° Micro Head and Two-Piece angle correction. Angle correction available in 0°, 5°, 11°, 17°, 23° and 30°. Intended for For surgical implantation in the maxillary or mandibular arch to support dental restorations such as artificial teeth, in order to restore the patient’s chewing function. Intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems.
STERNGOLD DENTAL LLC
901462
Not in Commercial Distribution

  • 00841549108099 ()


  • Dental implant suprastructure, permanent, preformed
Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant features the capability to correct implant mis-angulation. Four unique angle options offer flexibility to achieve the desired path of insertion for denture stabilization, even when implants are placed in narrow, resorbed ridges. The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization.This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments. Available in two styles, One-Piece, 0° Micro Head and Two-Piece angle correction. Angle correction available in 0°, 5°, 11°, 17°, 23° and 30°. Intended for surgical implantation in the maxillary or mandibular arch to support dental restorations such as artificial teeth, in order to restore the patient’s chewing function. Intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems.
STERNGOLD DENTAL LLC
901461
Not in Commercial Distribution

  • 00841549108082 ()


  • Dental implant suprastructure, permanent, preformed
Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant features the capability to correct implant mis-angulation. Four unique angle options offer flexibility to achieve the desired path of insertion for denture stabilization, even when implants are placed in narrow, resorbed ridges. The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization. This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments. Available in two styles, One-Piece, 0° Micro Head and Two-Piece angle correction. Angle correction available in 0°, 5°, 11°, 17°, 23° and 30°. Intended for surgical implantation in the maxillary or mandibular arch to support dental restorations such as artificial teeth, in order to restore the patient’s chewing function. Intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems.
STERNGOLD DENTAL LLC
901460
Not in Commercial Distribution

  • 00841549108075 ()


  • Dental implant suprastructure, permanent, preformed
Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant features the capability to correct implant mis-angulation. Four unique angle options offer flexibility to achieve the desired path of insertion for denture stabilization, even when implants are placed in narrow, resorbed ridges. The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization.This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments. Available in two styles One-Piece, 0° Micro Head and Two-Piece angle correction. Angle correction available in 0°, 5°, 11°, 17°, 23° and 30°. Intended for For surgical implantation in the maxillary or mandibular arch to support dental restorations such as artificial teeth, in order to restore the patient’s chewing function. Intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems.
STERNGOLD DENTAL LLC
901459
Not in Commercial Distribution

  • 00841549108068 ()


  • Dental implant suprastructure, permanent, preformed
Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant features the capability to correct implant mis-angulation. Four unique angle options offer flexibility to achieve the desired path of insertion for denture stabilization, even when implants are placed in narrow, resorbed ridges. The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization.This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments. Available in two styles One-Piece, 0° Micro Head and Two-Piece angle correction. Angle correction available in 0°, 5°, 11°, 17°, 23° and 30°. Intended for For surgical implantation in the maxillary or mandibular arch to support dental restorations such as artificial teeth, in order to restore the patient’s chewing function. Intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems.
STERNGOLD DENTAL LLC
901458
Not in Commercial Distribution

  • 00841549108051 ()


  • Dental implant suprastructure, permanent, preformed
Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant features the capability to correct implant mis-angulation. Four unique angle options offer flexibility to achieve the desired path of insertion for denture stabilization, even when implants are placed in narrow, resorbed ridges. The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization. This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments. Available in two styles – One-Piece, 0° Micro Head and Two-Piece angle correction. Angle correction available in 0°, 5°, 11°, 17°, 23° and 30°. Intended for surgical implantation in the maxillary or mandibular arch to support dental restorations such as artificial teeth, in order to restore the patient’s chewing function. Intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems.
STERNGOLD DENTAL LLC
901457
Not in Commercial Distribution

  • 00841549108044 ()


  • Dental implant suprastructure, permanent, preformed
Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant features the capability to correct implant mis-angulation. Four unique angle options offer flexibility to achieve the desired path of insertion for denture stabilization, even when implants are placed in narrow, resorbed ridges. The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization. This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments. Available in two styles, One-Piece, 0° Micro Head and Two-Piece angle correction. Angle correction available in 0°, 5°, 11°, 17°, 23° and 30°. Intended for surgical implantation in the maxillary or mandibular arch to support dental restorations such as artificial teeth, in order to restore the patient’s chewing function. Intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems.
STERNGOLD DENTAL LLC
901456
Not in Commercial Distribution

  • 00841549108037 ()


  • Dental implant suprastructure, permanent, preformed
Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant features the capability to correct implant mis-angulation. Four unique angle options offer flexibility to achieve the desired path of insertion for denture stabilization, even when implants are placed in narrow, resorbed ridges. The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization.This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments. Available in two styles One-Piece, 0° Micro Head and Two-Piece angle correction. Angle correction available in 0°, 5°, 11°, 17°, 23° and 30°. Intended for For surgical implantation in the maxillary or mandibular arch to support dental restorations such as artificial teeth, in order to restore the patient’s chewing function. Intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems.
STERNGOLD DENTAL LLC
901455
Not in Commercial Distribution

  • 00841549108020 ()


  • Dental implant suprastructure, permanent, preformed
Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant features the capability to correct implant mis-angulation. Four unique angle options offer flexibility to achieve the desired path of insertion for denture stabilization, even when implants are placed in narrow, resorbed ridges. The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization.This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments. Available in two styles One-Piece, 0° Micro Head and Two-Piece angle correction. Angle correction available in 0°, 5°, 11°, 17°, 23° and 30°. Intended for For surgical implantation in the maxillary or mandibular arch to support dental restorations such as artificial teeth, in order to restore the patient’s chewing function. Intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems.
STERNGOLD DENTAL LLC
901454
Not in Commercial Distribution

  • 00841549108013 ()


  • Dental implant suprastructure, permanent, preformed
Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant features the capability to correct implant mis-angulation. Four unique angle options offer flexibility to achieve the desired path of insertion for denture stabilization, even when implants are placed in narrow, resorbed ridges. The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization. This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments. Available in two styles, ne-Piece, 0° Micro Head and Two-Piece angle correction. Angle correction available in 0°, 5°, 11°, 17°, 23° and 30°. Intended for surgical implantation in the maxillary or mandibular arch to support dental restorations such as artificial teeth, in order to restore the patient’s chewing function. Intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems.
STERNGOLD DENTAL LLC
901453
Not in Commercial Distribution

  • 00841549108006 ()


  • Dental implant suprastructure, permanent, preformed
Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant features the capability to correct implant mis-angulation. Four unique angle options offer flexibility to achieve the desired path of insertion for denture stabilization, even when implants are placed in narrow, resorbed ridges. The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization. This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments. Available in two styles, One-Piece, 0° Micro Head and Two-Piece angle correction. Angle correction available in 0°, 5°, 11°, 17°, 23° and 30°. Intended for surgical implantation in the maxillary or mandibular arch to support dental restorations such as artificial teeth, in order to restore the patient’s chewing function. Intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems.
STERNGOLD DENTAL LLC
901452
Not in Commercial Distribution

  • 00841549107993 ()


  • Dental implant suprastructure, permanent, preformed
This abdominal binder belt brace was designed to provide abdominal content containment, particularly during early patient mobilization after abdominal surgery. It provides hernia support, back pain relief, obesity-related discomfort, weak abdominal muscle support and is very effective to help with post-pregnancy abdominal support. This binder is available in a wide range of sizes up to 55-inch circumference and is 10.2 inches in height. It is made with two wide panels providing an innovative locking system based on twin crisscrossing straps that offer an easy fit for all different shapes and sizes. Easy to put and adjustable for a comfortable fit. Made with the patient in mind, with super soft natural materials, 85% Cotton,and 15% Elastane. Made in Italy. Benefits: 24H COMFORT, SUPER SLIM, BREATHABLE, ULTRA LIGHT, EASY TO USE, WASHABLE, WATER WICKING FIBERS, TWO WIDE PANEL STRAPS, ADJUSTABLE COMPRESSION. INDICATIONS Umbilical Hernia Post Pregnancy Abdomen Support Hernia Support Back Support Abdomen Injury Post Surgery Support General Abdomen Containment
INDACO SRL
515 3XL
In Commercial Distribution

  • 05391512286521 ()
  • 05391512284343 ()
515

  • Abdominal binder, reusable
This abdominal binder belt brace was designed to provide abdominal content containment, particularly during early patient mobilization after abdominal surgery. It provides hernia support, back pain relief, obesity-related discomfort, weak abdominal muscle support and is very effective to help with post-pregnancy abdominal support. This binder is available in a wide range of sizes up to 55-inch circumference and is 10.2 inches in height. It is made with two wide panels providing an innovative locking system based on twin crisscrossing straps that offer an easy fit for all different shapes and sizes. Easy to put and adjustable for a comfortable fit. Made with the patient in mind, with super soft natural materials, 85% Cotton,and 15% Elastane. Made in Italy. Benefits: 24H COMFORT, SUPER SLIM, BREATHABLE, ULTRA LIGHT, EASY TO USE, WASHABLE, WATER WICKING FIBERS, TWO WIDE PANEL STRAPS, ADJUSTABLE COMPRESSION. INDICATIONS Umbilical Hernia Post Pregnancy Abdomen Support Hernia Support Back Support Abdomen Injury Post Surgery Support General Abdomen Containment
INDACO SRL
515 XXL
In Commercial Distribution

  • 05391512286514 ()
  • 05391512284336 ()
515

  • Abdominal binder, reusable
This abdominal binder belt brace was designed to provide abdominal content containment, particularly during early patient mobilization after abdominal surgery. It provides hernia support, back pain relief, obesity-related discomfort, weak abdominal muscle support and is very effective to help with post-pregnancy abdominal support. This binder is available in a wide range of sizes up to 55-inch circumference and is 10.2 inches in height. It is made with two wide panels providing an innovative locking system based on twin crisscrossing straps that offer an easy fit for all different shapes and sizes. Easy to put and adjustable for a comfortable fit. Made with the patient in mind, with super soft natural materials, 85% Cotton,and 15% Elastane. Made in Italy. Benefits: 24H COMFORT, SUPER SLIM, BREATHABLE, ULTRA LIGHT, EASY TO USE, WASHABLE, WATER WICKING FIBERS, TWO WIDE PANEL STRAPS, ADJUSTABLE COMPRESSION. INDICATIONS Umbilical Hernia Post Pregnancy Abdomen Support Hernia Support Back Support Abdomen Injury Post Surgery Support General Abdomen Containment
INDACO SRL
515 XL
In Commercial Distribution

  • 05391512286507 ()
  • 05391512284329 ()
515

  • Abdominal binder, reusable
This abdominal binder belt brace was designed to provide abdominal content containment, particularly during early patient mobilization after abdominal surgery. It provides hernia support, back pain relief, obesity-related discomfort, weak abdominal muscle support and is very effective to help with post-pregnancy abdominal support. This binder is available in a wide range of sizes up to 55-inch circumference and is 10.2 inches in height. It is made with two wide panels providing an innovative locking system based on twin crisscrossing straps that offer an easy fit for all different shapes and sizes. Easy to put and adjustable for a comfortable fit. Made with the patient in mind, with super soft natural materials, 85% Cotton,and 15% Elastane. Made in Italy. Benefits: 24H COMFORT, SUPER SLIM, BREATHABLE, ULTRA LIGHT, EASY TO USE, WASHABLE, WATER WICKING FIBERS, TWO WIDE PANEL STRAPS, ADJUSTABLE COMPRESSION. INDICATIONS Umbilical Hernia Post Pregnancy Abdomen Support Hernia Support Back Support Abdomen Injury Post Surgery Support General Abdomen Containment
INDACO SRL
515 L
In Commercial Distribution

  • 05391512286491 ()
  • 05391512284312 ()
515

  • Abdominal binder, reusable
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