Identity
- Trade Name
- CollaFlex FDA UDI
- Generic Name
- Collagen dental regeneration membrane FDA UDI
- Device Name
- Resorbable COLLAFLEX® membranes are derived from porcine pericardium through careful purification and sterilization processes to avoid antigenic reactions. The non-cross-linked membranes retain the natural microfibril structure of the pericardium, providing excellent biocompatibility and extended barrier function for guided bone regeneration applications. COLLAFLEX® membranes are easily drapable and can be fixated with sutures and bone tacks. FDA UDI
- Model / Reference
- 30mm x 40mm FDA UDI
- Description
- Resorbable COLLAFLEX® membranes are derived from porcine pericardium through careful purification and sterilization processes to avoid antigenic reactions. The non-cross-linked membranes retain the natural microfibril structure of the pericardium, providing excellent biocompatibility and extended barrier function for guided bone regeneration applications. COLLAFLEX® membranes are easily drapable and can be fixated with sutures and bone tacks. FDA UDI
Identifiers
- Catalog Number
- C07-0301 FDA UDI
- Primary DI / UDI-DI
- D767C0703010 FDA UDI
- 510(k) Number
- K200623 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
CollaFlex by Unicare Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Collagen dental regeneration membrane.
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- Reguarde — COLLAGEN MATRIX, INC. · Class II
Cleared under the same submission
K200623 also covers:
- Oradapt — HYUNDAI BIOLAND Co., Ltd.
- Oradapt — HYUNDAI BIOLAND Co., Ltd.
- Oradapt — HYUNDAI BIOLAND Co., Ltd.
- OssGuide — HYUNDAI BIOLAND Co., Ltd.
- OssGuide — HYUNDAI BIOLAND Co., Ltd.
- OssGuide — HYUNDAI BIOLAND Co., Ltd.
- OssGuide — HYUNDAI BIOLAND Co., Ltd.
- OssGuide — HYUNDAI BIOLAND Co., Ltd.
- OsseoSeal — HYUNDAI BIOLAND Co., Ltd.
- OsseoSeal — HYUNDAI BIOLAND Co., Ltd.
- OsseoSeal — HYUNDAI BIOLAND Co., Ltd.
- T-Gen — HYUNDAI BIOLAND Co., Ltd.
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
- Unicare Biomedical, Inc.
Sources (1)
- FDA UDI 83ee71cb-c2eb-46a0-89e5-c056b8eed86b 38 fields · synced May 31, 2026