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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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Unigraft is made of synthetic bioactive glass material. The product is conveniently packaged in a sterile vial and stored within a hermetically sealed foil pouch to ensure product sterility prior to implantation. Unigraft offers an osteogenic framework for new bone growth and bolsters a higher level of osteoblastic activity to enhance bone regeneration. FDA has cleared this product for use in treating periodontal defects, extractions sites, sinus elevation, apicoectomy and root resection, cranial and facial augmentation and augmentation of the alveolar ridges.
UNICARE BIOMEDICAL INC.
200-400um 1.0g
In Commercial Distribution

  • D767U0102051 ()
  • D767U010201 ()
U01-0205

  • Synthetic bone graft
Unigraft is made of synthetic bioactive glass material. The product is conveniently packaged in a sterile vial and stored within a hermetically sealed foil pouch to ensure product sterility prior to implantation. Unigraft offers an osteogenic framework for new bone growth and bolsters a higher level of osteoblastic activity to enhance bone regeneration. FDA has cleared this product for use in treating periodontal defects, extractions sites, sinus elevation, apicoectomy and root resection, cranial and facial augmentation and augmentation of the alveolar ridges.
UNICARE BIOMEDICAL INC.
200-400um 0.4g
In Commercial Distribution

  • D767U0101051 ()
  • D767U010101 ()
U01-0105

  • Synthetic bone graft
Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and 40% beta-tri-calcium phosphate (TCP). These materials have been the topic of extensive clinical studies for several decades. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. After implantation, the device resorbs and is later replaced by natural bone.
BERKELEY ADVANCED BIOMATERIALS, LLC
C10 SWE12
In Commercial Distribution

  • 00816125023776 ()
C10 SWE12

  • Bone matrix implant, synthetic, non-antimicrobial
Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and 40% beta-tri-calcium phosphate (TCP). These materials have been the topic of extensive clinical studies for several decades. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. After implantation, the device resorbs and is later replaced by natural bone.
BERKELEY ADVANCED BIOMATERIALS, LLC
C10 SWE10
In Commercial Distribution

  • 00816125023769 ()
C10 SWE10

  • Bone matrix implant, synthetic, non-antimicrobial
Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and 40% beta-tri-calcium phosphate (TCP). These materials have been the topic of extensive clinical studies for several decades. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. After implantation, the device resorbs and is later replaced by natural bone.
BERKELEY ADVANCED BIOMATERIALS, LLC
C10 SWE08
In Commercial Distribution

  • 00816125023752 ()
C10 SWE08

  • Bone matrix implant, synthetic, non-antimicrobial
Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and 40% beta-tri-calcium phosphate (TCP). These materials have been the topic of extensive clinical studies for several decades. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. After implantation, the device resorbs and is later replaced by natural bone.
BERKELEY ADVANCED BIOMATERIALS, LLC
C10 SWE06
In Commercial Distribution

  • 00816125023745 ()
C10 SWE06

  • Bone matrix implant, synthetic, non-antimicrobial
Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and 40% beta-tri-calcium phosphate (TCP). These materials have been the topic of extensive clinical studies for several decades. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. After implantation, the device resorbs and is later replaced by natural bone.
BERKELEY ADVANCED BIOMATERIALS, LLC
C10 SWC08
In Commercial Distribution

  • 00816125023738 ()
C10 SWC08

  • Bone matrix implant, synthetic, non-antimicrobial
Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and 40% beta-tri-calcium phosphate (TCP). These materials have been the topic of extensive clinical studies for several decades. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. After implantation, the device resorbs and is later replaced by natural bone.
BERKELEY ADVANCED BIOMATERIALS, LLC
C10 SWC07
In Commercial Distribution

  • 00816125023721 ()
C10 SWC07

  • Bone matrix implant, synthetic, non-antimicrobial
Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and 40% beta-tri-calcium phosphate (TCP). These materials have been the topic of extensive clinical studies for several decades. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. After implantation, the device resorbs and is later replaced by natural bone.
BERKELEY ADVANCED BIOMATERIALS, LLC
C10 SWC06
In Commercial Distribution

  • 00816125023714 ()
C10 SWC06

  • Bone matrix implant, synthetic, non-antimicrobial
Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and 40% beta-tri-calcium phosphate (TCP). These materials have been the topic of extensive clinical studies for several decades. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. After implantation, the device resorbs and is later replaced by natural bone.
BERKELEY ADVANCED BIOMATERIALS, LLC
C10 SWC05
In Commercial Distribution

  • 00816125023707 ()
C10 SWC05

  • Bone matrix implant, synthetic, non-antimicrobial
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