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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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The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and to support a patient-specific ceramic superstructure or a multi-unit direct restoration cemented to the base. The base and the superstructure form a patient-specific abutment that will support a definitive restoration, either a single crown or a multi-unit restoration. The Elos Accurate Hybrid Base Engaging is intended for single-unit restorations and Elos Accurate Hybrid Base Nonengaging is intended for multi-unit restorations. Alternatively, a definitive multi-unit restoration may be cemented directly to the Elos Accurate Hybrid Base.
Elos Medtech Pinol A/S
HBE-ATE30H-1
In Commercial Distribution

  • 05712821006776 ()


  • Dental implant suprastructure, permanent, preformed
A driver for a dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic screws during oral surgery and prosthetic procedures.
Elos Medtech Pinol A/S
C11108
In Commercial Distribution

  • 05712821006769 ()
  • 05712821009371 ()


  • Surgical torque wrench adaptor
A dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic screws during oral surgery and prosthetic procedures.
Elos Medtech Pinol A/S
ZTIRW
In Commercial Distribution

  • 05712821006738 ()
  • 05712821006745 ()


  • Surgical torque wrench, reusable
A driver for a dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic screws during oral surgery and prosthetic procedures.
Elos Medtech Pinol A/S
C9981
In Commercial Distribution

  • 05712821006646 ()
  • 05712821009418 ()


  • Surgical torque wrench adaptor
A driver for a dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic screws during oral surgery and prosthetic procedures.
Elos Medtech Pinol A/S
C9980
In Commercial Distribution

  • 05712821006639 ()
  • 05712821009395 ()


  • Surgical torque wrench adaptor
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
AS-ATEM208POS
In Commercial Distribution

  • 05712821006592 ()


  • Dental prosthesis/implant abutment screw
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
AS-ATEM188POS
In Commercial Distribution

  • 05712821006585 ()


  • Dental prosthesis/implant abutment screw
A dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic screws during oral surgery and prosthetic procedures.
Elos Medtech Pinol A/S
H-TIRW
In Commercial Distribution

  • 05712821006578 ()
  • 05712821006622 ()


  • Surgical torque wrench, reusable
A dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic screws during oral surgery and prosthetic procedures.
Elos Medtech Pinol A/S
L-TIRW
In Commercial Distribution

  • 05712821006561 ()
  • 05712821006615 ()
C9244

  • Surgical torque wrench, reusable
The product consists of the Elos Accurate® Analog for Printed Models (Analog) manufactured in the biocompatible material titanium alloy grade 5 ELI (TiAl6V4 ELI).
Elos Medtech Pinol A/S
90192
In Commercial Distribution

  • 05712821006554 ()
90192

  • Dental implant analog
The product consists of the Elos Accurate® Analog for Printed Models (Analog) manufactured in the biocompatible material titanium alloy grade 5 ELI (TiAl6V4 ELI).
Elos Medtech Pinol A/S
90191
In Commercial Distribution

  • 05712821006547 ()
90191

  • Dental implant analog
The product consists of the Elos Accurate® Analog for Printed Models (Analog) manufactured in the biocompatible material titanium alloy grade 5 ELI (TiAl6V4 ELI).
Elos Medtech Pinol A/S
90190
In Commercial Distribution

  • 05712821006530 ()
90190

  • Dental implant analog
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
C13048
In Commercial Distribution

  • 05712821006523 ()
  • 05712821009319 ()
C13048

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
C18512
In Commercial Distribution

  • 05712821006516 ()
  • 05712821009302 ()
C18512

  • Dental implant suprastructure, temporary, preformed, reusable
The product consists of the Prosthetic Screwdriver which is manufactured from stainless steel. The product is available in different lengths. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
PS-AH34-1
In Commercial Distribution

  • 05712821006509 ()
  • 05712821009517 ()
PS-AH34-1

  • Surgical screwdriver, reusable
The product consists of the Prosthetic Screwdriver which is manufactured from stainless steel. The product is available in different lengths. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
PS-AH26-1
In Commercial Distribution

  • 05712821006493 ()
  • 05712821009500 ()
PS-AH26-1

  • Surgical screwdriver, reusable
The product consists of the Prosthetic Screwdriver which is manufactured from stainless steel. The product is available in different lengths. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
PS-AH18-1
In Commercial Distribution

  • 05712821006486 ()
  • 05712821009494 ()
PS-AH18-1

  • Surgical screwdriver, reusable
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 2B-D SA
In Commercial Distribution

  • 05712821006479 ()
  • 05712821008619 ()
N/a

  • Dental implant suprastructure, temporary, preformed, reusable
The Elos Torque Wrench (main body, head and Elos Driver) is made of lightweight titanium and stainless steel. The Elos Torque Wrench & Driver product design, finish and quality make the tool well suited for placement and adjustment of implants, abutments and screws during surgery and other clinical procedures. The Elos Torque Wrench & Driver is easy to prepare for cleaning, disinfection and sterilization. Exchangeable screwdrivers and the Elos Driver make the tool compatible to various implant systems. The driver is available for a variety of connections. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
C10086
In Commercial Distribution

  • 05712821006462 ()
  • 05712821009449 ()


  • Surgical torque wrench adaptor
The Elos Torque Wrench (main body, head and Elos Driver) is made of lightweight titanium and stainless steel. The Elos Torque Wrench & Driver product design, finish and quality make the tool well suited for placement and adjustment of implants, abutments and screws during surgery and other clinical procedures. The Elos Torque Wrench & Driver is easy to prepare for cleaning, disinfection and sterilization. Exchangeable screwdrivers and the Elos Driver make the tool compatible to various implant systems. The driver is available for a variety of connections. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
C10110
In Commercial Distribution

  • 05712821006455 ()
  • 05712821009425 ()


  • Surgical torque wrench adaptor
The Elos Torque Wrench (main body, head and Elos Driver) is made of lightweight titanium and stainless steel. The Elos Torque Wrench & Driver product design, finish and quality make the tool well suited for placement and adjustment of implants, abutments and screws during surgery and other clinical procedures. The Elos Torque Wrench & Driver is easy to prepare for cleaning, disinfection and sterilization. Exchangeable screwdrivers and the Elos Driver make the tool compatible to various implant systems. The driver is available for a variety of connections. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
C9866
In Commercial Distribution

  • 05712821006448 ()
  • 05712821006431 ()


  • Surgical torque wrench, reusable
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
4A-B
In Commercial Distribution

  • 05712821006424 ()
  • 05712821009289 ()
N/a

  • Dental implant abutment analog, laboratory
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
4A-A
In Commercial Distribution

  • 05712821006417 ()
  • 05712821009272 ()
N/a

  • Dental implant abutment analog, laboratory
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
3A-C
In Commercial Distribution

  • 05712821006400 ()
  • 05712821009265 ()
N/a

  • Dental implant abutment analog, laboratory
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
3A-B
In Commercial Distribution

  • 05712821006394 ()
  • 05712821009258 ()
N/a

  • Dental implant abutment analog, laboratory
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
3A-A
In Commercial Distribution

  • 05712821006387 ()
  • 05712821009241 ()
N/a

  • Dental implant abutment analog, laboratory
The product consists of the Elos Accurate® Analog for Printed Models (Analog) manufactured in the biocompatible material titanium alloy grade 5 ELI (TiAl6V4 ELI).
Elos Medtech Pinol A/S
PMA-BHI45-1
In Commercial Distribution

  • 05712821006370 ()
N/a

  • Dental implant analog
The product consists of the Elos Accurate® Analog for Printed Models (Analog) manufactured in the biocompatible material titanium alloy grade 5 ELI (TiAl6V4 ELI).
Elos Medtech Pinol A/S
PMA-BHI35-1
In Commercial Distribution

  • 05712821006363 ()
N/a

  • Dental implant analog
The product consists of the Elos Accurate® Analog for Printed Models (Analog) manufactured in the biocompatible material titanium alloy grade 5 ELI (TiAl6V4 ELI).
Elos Medtech Pinol A/S
PMA-BHI30-1
In Commercial Distribution

  • 05712821006356 ()
N/a

  • Dental implant analog
The product consists of the Elos Accurate® Analog for Printed Models (Analog) manufactured in the biocompatible material titanium alloy grade 5 ELI (TiAl6V4 ELI).
Elos Medtech Pinol A/S
PMA-BHI57-1
In Commercial Distribution

  • 05712821006349 ()
N/a

  • Dental implant analog
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