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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.

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.

This 510(k) summary for the OTA Collagen Biomaterial does not contain information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document states that the device is substantially equivalent to predicate devices based on similarities in intended use, operating principle, basic design, materials, and sterilization process. This is a common approach in 510(k) submissions, where direct performance testing against specific acceptance criteria is often not required if substantial equivalence to a legally marketed predicate device can be demonstrated.

Therefore, I cannot populate the requested tables or answer the specific questions directly from the provided text. The document focuses on demonstrating substantial equivalence, not on presenting a study with performance metrics against acceptance criteria.

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