Identity
- Trade Name
- ORAMEM-SUS-20X30 FDA UDI
- Generic Name
- Dental/maxillofacial soft-tissue biomatrix implant, animal-derived FDA UDI
- Device Name
- Salvin OraMem-Sustained Collagen Membrane 20x30mm FDA UDI
- Model / Reference
- REV7/08 FDA UDI
- Description
- Salvin OraMem-Sustained Collagen Membrane 20x30mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841336100862 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
- 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
No
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: Dental/maxillofacial soft-tissue biomatrix implant, animal-derived
Oramem-Sus-20x30 by Salvin Dental Specialties, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental/maxillofacial soft-tissue biomatrix implant, animal-derived.
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- Geistlich Mucograft® Seal — Geistlich Pharma AG · Class II
- Integra® Miltex® Helimend® Advanced — Integra Lifesciences Corp. · Class II
- HeliMend® Advanced — Integra Lifesciences Corp. · Class II
- COPIOS® Pericardium Membrane — Tutogen Medical GmbH · 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.
- 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-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
- Salvin Dental Specialties, Llc
Sources (1)
- FDA UDI 4e1ad366-adee-4b61-983a-99a558828734 34 fields · synced May 31, 2026