Identity
- Trade Name
- GuidOss FDA UDI
- Generic Name
- Collagen dental regeneration membrane FDA UDI
- Device Name
- GuidOss is made from pure Type I porcine collagen membrane. It is a resorbable collagen membrane for guided tissue and bone regenerations. The Type I collagen is obtained from porcine skin purified to avoid immunological reactions. The GuidOss membrane is manufactured by fibrillogenesis and glycation with sugar (ribose). The collagen fibers are self-assembled by the process of fibrillogenesis. The glycation is a natural process of cross-linking of collagen occurring in vivo. The glycated collagen fibers exhibit increased mechanical strength, thermal stability and increased resistance to pepsin digestion compared to non-glycated collagen. FDA UDI
- Model / Reference
- GDS 1-2515 FDA UDI
- Description
- GuidOss is made from pure Type I porcine collagen membrane. It is a resorbable collagen membrane for guided tissue and bone regenerations. The Type I collagen is obtained from porcine skin purified to avoid immunological reactions. The GuidOss membrane is manufactured by fibrillogenesis and glycation with sugar (ribose). The collagen fibers are self-assembled by the process of fibrillogenesis. The glycation is a natural process of cross-linking of collagen occurring in vivo. The glycated collagen fibers exhibit increased mechanical strength, thermal stability and increased resistance to pepsin digestion compared to non-glycated collagen. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809186549578 FDA UDI
- 510(k) Number
- K133507 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
Yes
FDA UDI
Category: Collagen dental regeneration membrane
GuidOss by Nibec Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ORAFOAM-PKG-18 — SALVIN DENTAL SPECIALTIES, LLC · Class II
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- Geistlich Bio-Gide® — Geistlich Pharma AG · Class II
Cleared under the same submission
K133507 also covers:
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
- Nibec Co., Ltd.
Sources (1)
- FDA UDI 39a5590d-fa39-4bd2-ad94-2112b5ffb4cc 37 fields · synced May 30, 2026