Identity
- Trade Name
- OssGuide FDA UDI
- Generic Name
- Collagen dental regeneration membrane FDA UDI
- Device Name
- Absorbable collagen membrane FDA UDI
- Model / Reference
- TG-3 FDA UDI
- Description
- Absorbable collagen membrane FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800048502069 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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 40 Millimeter FDA UDIWidth — 30 Millimeter FDA UDI
Category: Collagen dental regeneration membrane
OssGuide by HYUNDAI BIOLAND Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Collagen dental regeneration membrane.
- Neogen Collagen Flex S — COLLAGEN MATRIX, INC. · Class II
- GuidOss — Nibec Co., Ltd. · Class II
- 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
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.
- OsseoSeal — HYUNDAI BIOLAND Co., Ltd.
- OsseoSeal — HYUNDAI BIOLAND Co., Ltd.
- OsseoSeal — HYUNDAI BIOLAND Co., Ltd.
- T-Gen — 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
- HYUNDAI BIOLAND Co., Ltd.
Sources (1)
- FDA UDI 2d9ce826-e95e-4570-a189-ffd877ce64b8 35 fields · synced Jun 8, 2026