Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen Menbrane
FDA 510(k) K992216 · Integra Lifesciences Corp.
510(k) numberK992216
Submission
- Device name
- Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen Menbrane
- Applicant
- Integra Lifesciences Corp.
Plainsboro, NJ, US - Received
- July 1, 1999
- Decision date
- July 26, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYC – Bone Grafting Material, Synthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3930
- Specialty
- Dental
- Implant
- Yes
A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.
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Questions and answers
When was Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen Menbrane cleared by the FDA?
Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen Menbrane (K992216) received a 510(k) decision of Substantially Equivalent on July 26, 1999, 25 days after the submission was received.
What is the product code of K992216?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.