Identity
- Trade Name
- S1 FDA UDI
- Generic Name
- Dental bone matrix implant, animal-derived FDA UDI
- Device Name
- Bone grafting material - Dental FDA UDI
- Model / Reference
- S1-XB-C200 FDA UDI
- Description
- Bone grafting material - Dental FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800045217355 FDA UDI
- FDA Product Code
- NPM FDA UDI
- GMDN Term
- Dental bone matrix implant, animal-derived 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: Dental bone matrix implant, animal-derived
S1 by Medpark Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental bone matrix implant, animal-derived.
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- Instradent XenoGraft — Nibec Co., Ltd. · Class II
- creos xenogain — Nibec Co., Ltd. · Class II
- naturesQue MaxOss P — COLLAGEN MATRIX, INC. · Class II
- BoneMedik-DM, 2~4mm, 5cc — Meta Biomed, Inc. · Class II
- MinerOss® X — ACE SURGICAL SUPPLY CO., 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
- Medpark Co., Ltd.
Sources (1)
- FDA UDI 31bd25d2-3b50-449e-baf3-ccdc2c9c6077 33 fields · synced May 30, 2026