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510(k) Data Aggregation
K Number
K121177Device Name
BOND APATITE
Manufacturer
AUGMA BIOMATERIALS, LTD.
Date Cleared
2013-12-05
(596 days)
Product Code
LYC
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
AUGMA BIOMATERIALS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bond Apatite™ is a synthetic osteoconductive, bioresorbable bone grafting material composed of hydroxyapatite and biphasic calcium sulfate in granulated powder form. intended to fill. augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
Device Description
Bond Apatite is composed of hydroxyapatite and biphasic calcium sulfate in granulated powder form. The hydroxyapatite component is sintered hydroxyapatite granules that conform to ISO 13779-1 Implants for surgery - Hydroxyapatite - Part 1: Ceramic Hydroxyapatite and ISO 13779-3 Implants for surgery – Hydroxyapatite – Part 3: Chemical analysis and characterization of crystallinity and phase purity. The calcium sulfate material is Bond Bone™, a mixture of surgical grade calcium sulfate dihydrate and calcium sulfate hemihydrate, and cleared under K083858. The calcium suffate component conforms to the chemical requirements of ASTM F2224 Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants. Bone Apatite is provided sterile, in a single unit size of 1 cc in a disposable applicator that is used for mixing the dry powder with sterile saline and for delivery to the treatment site.
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K Number
K083858Device Name
BOND BONE
Manufacturer
AUGMA BIOMATERIALS, LTD.
Date Cleared
2009-03-17
(83 days)
Product Code
LYC
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
AUGMA BIOMATERIALS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bond Bone™ is indicated for use in the following ways: by itself in bone regenerative techniques, mixed with other suitable bone filling agents to prevent particle migration in an osseous defect, and to provide a resorbable barrier over other bone graft material.
Device Description
Bond Bone™ is a synthetic ostcoconductive, bioresorbable bone grafting material composed of biphasic calcium sulfate in granulated powder form, intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. When mixed with saline, Bond Bone forms a paste and hardens via a cementitious reaction. The product is provided sterile and for single patient use.
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