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510(k) Data Aggregation
K Number
K073685Device Name
OTA COLLAGEN BIOMATERIAL
Manufacturer
OSSEOUS TECHNOLOGIES OF AMERICA
Date Cleared
2008-08-29
(245 days)
Product Code
NPL, CLA, NPM
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
OSSEOUS TECHNOLOGIES OF AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OTA Collagen Biomaterial is intended for use in dental surgery procedures as a resorbable material for placement in the area of dental implants, bone defects or ridge reconstruction to aid in wound healing post dental surgery.
Device Description
OTA Collagen Biomaterial is an off-white, biocompatible, non-friable, resorbable membrane matrix engineered from highly purified type I collagen derived from bovine Achilles tendon. When moistened with water, saline, serum or blood, the porous material is flexible and conforms to the contours of the defect site. The material is easily cut with scissors or scalpel to meet the needs of the surgeon. OTA Collagen Biomaterial is non-pyrogenic and is provided sterile for single use only.
OTA Collagen Biomaterial is available in four shapes and a number of sizes. It can be applied as an onlay to cover simple defects or can be used for bone graft containment.
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