Identity
- Trade Name
- Salvin OraMem® FDA UDI
- Generic Name
- Dental/maxillofacial soft-tissue biomatrix implant, animal-derived FDA UDI
- Device Name
- #ORAMEM SUS 20x30 OraMem Sustained absorbable collagen membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus. OraMem Sustained absorbable collagen membrane is a white, compressed, non-friable matrix fabricated from collagen derived from bovine deep flexor (Achillies) tendon. Bovine tendon is known to be one of the purest sources of Type I collagen that can be readily obtained and processed in commercial amounts. The OraMem Sustained membrane is completely absorbable, eliminating the need for the second surgical procedure required to remove a non-resorbable membrane. The collagen is currently used for general and dental surgery as absorbable hemostatic agents and absorbable wound dressings. FDA UDI
- Model / Reference
- #ORAMEMSUS20X30 FDA UDI
- Description
- #ORAMEM SUS 20x30 OraMem Sustained absorbable collagen membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus. OraMem Sustained absorbable collagen membrane is a white, compressed, non-friable matrix fabricated from collagen derived from bovine deep flexor (Achillies) tendon. Bovine tendon is known to be one of the purest sources of Type I collagen that can be readily obtained and processed in commercial amounts. The OraMem Sustained membrane is completely absorbable, eliminating the need for the second surgical procedure required to remove a non-resorbable membrane. The collagen is currently used for general and dental surgery as absorbable hemostatic agents and absorbable wound dressings. FDA UDI
Identifiers
- Catalog Number
- #ORAMEMSUS20X30 FDA UDI
- Primary DI / UDI-DI
- 10381780072614 FDA UDI
- 510(k) Number
- K992216 FDA UDI
- FDA Product Code
- LYC FDA UDI
- GMDN Term
- Dental/maxillofacial soft-tissue biomatrix implant, animal-derived FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3930 FDA UDI
- Commercial Distribution
- Not 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
Salvin OraMem® by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K992216 also covers:
- BioMend® Extend™ Absorbable Collagen Membrane — Integra Lifesciences Corp.
- 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 |
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Manufacturer
- Manufacturer
- Integra Lifesciences Corp.
Sources (1)
- FDA UDI d40c1d35-bb8d-4139-ae9a-5ce7266e5075 39 fields · synced May 30, 2026