Identity
- Trade Name
- Kontour™ Sustain FDA UDI
- Generic Name
- Collagen dental regeneration membrane FDA UDI
- Device Name
- Kontour™ Sustain Resorbable Collagen Membrane - 20mm x 30mm FDA UDI
- Model / Reference
- KRM2030 FDA UDI
- Description
- Kontour™ Sustain Resorbable Collagen Membrane - 20mm x 30mm FDA UDI
Identifiers
- Catalog Number
- KRM2030 FDA UDI
- Primary DI / UDI-DI
- 10841307130550 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
Category: Collagen dental regeneration membrane
Kontour™ Sustain by Implant Direct Sybron Manufacturing Llc — 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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- 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
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
- Implant Direct Sybron Manufacturing Llc
Sources (1)
- FDA UDI 29ec1424-8f59-4614-afbd-16829360a1c7 37 fields · synced Jun 8, 2026