Identity
- Trade Name
- OSSIX Agile™ FDA UDI
- Generic Name
- Collagen dental regeneration membrane FDA UDI
- Device Name
- Cross-linked pericardium membrane FDA UDI
- Model / Reference
- 68018006 FDA UDI
- Description
- Cross-linked pericardium membrane FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290015477369 FDA UDI
- 510(k) Number
- K212509 FDA UDI
- FDA Product Code
- NPL 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
Dimensions & Sizes
- Size
- Width — 20 Millimeter FDA UDILength — 30 Millimeter FDA UDI
Category: Collagen dental regeneration membrane
OSSIX Agile™ by Datum Dental Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Collagen dental regeneration membrane.
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- 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
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
- Datum Dental Ltd
Sources (1)
- FDA UDI 5dcb94c4-7e1c-4834-a253-03e73e8bda65 35 fields · synced May 30, 2026