Identity
- Trade Name
- BioMend® Extend™ Absorbable Collagen Membrane FDA UDI
- Generic Name
- Collagen dental regeneration membrane FDA UDI
- Device Name
- BIOMEND EXTEND 30MM X 40MM (0142) BioMend Extend Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue generation procedures in periodontal defects to enhance regeneration of periodontal apparatus. The BioMend Extend membrane is a white, compressed, non-friable matrix fabricated from collagen derived from bovine deep flexor (Achilles) tendon. FDA UDI
- Model / Reference
- 0142 FDA UDI
- Description
- BIOMEND EXTEND 30MM X 40MM (0142) BioMend Extend Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue generation procedures in periodontal defects to enhance regeneration of periodontal apparatus. The BioMend Extend membrane is a white, compressed, non-friable matrix fabricated from collagen derived from bovine deep flexor (Achilles) tendon. FDA UDI
Identifiers
- Catalog Number
- 0142 FDA UDI
- Primary DI / UDI-DI
- 10381780070788 FDA UDI
- 510(k) Number
- K992216 FDA UDI
- FDA Product Code
- LYC FDA UDI
- GMDN Term
- Collagen dental regeneration membrane FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3930 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Collagen dental regeneration membrane
BioMend® Extend™ Absorbable Collagen Membrane by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Collagen dental regeneration membrane.
- Neogen Collagen Flex S — COLLAGEN MATRIX, INC. · Class II
- GuidOss — Nibec Co., Ltd. · Class II
- PLENA FLEX — COLLAGEN MATRIX, INC. · Class II
- Neogen Collagen Firm L — COLLAGEN MATRIX, INC. · Class II
- OUSIA bioMAINTAIN — ACE SURGICAL SUPPLY CO., INC. · Class II
- ORAFOAM-PKG-18 — SALVIN DENTAL SPECIALTIES, LLC · Class II
- Kontour Matrix — Matricel GmbH · Class II
- Reguarde — COLLAGEN MATRIX, INC. · Class II
Cleared under the same submission
K992216 also covers:
- BioMend® Extend™ Absorbable Collagen Membrane — Integra Lifesciences Corp.
- BioMend® Extend™ Absorbable Collagen Membrane — Integra Lifesciences Corp.
- HeliMend® Advanced — Integra Lifesciences Corp.
- Integra® Miltex® Helimend® Advanced — Integra Lifesciences Corp.
- Integra® Miltex® Helimend® Advanced — Integra Lifesciences Corp.
- ORAMEM-SUS-15X20 — SALVIN DENTAL SPECIALTIES, LLC
- ORAMEM-SUS-20X30 — SALVIN DENTAL SPECIALTIES, LLC
- ORAMEM-SUS-30X40 — SALVIN DENTAL SPECIALTIES, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Integra Lifesciences Corp.
Sources (1)
- FDA UDI 0e0b6c0b-a180-4b1d-98d3-ed46506d42b7 38 fields · synced May 30, 2026