Identity
- Trade Name
- Fibrafill® DENTIN Sample FDA UDI
- Generic Name
- Dental reinforcing fibre FDA UDI
- Model / Reference
- F-104 FDA UDI
Identifiers
- Catalog Number
- F-104 FDA UDI
- Primary DI / UDI-DI
- 08595652700726 FDA UDI
- 510(k) Number
- K952353 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental reinforcing fibre FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Dental reinforcing fibre
Fibrafill® DENTIN Sample by ADM, a.s. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- ADM, a.s.
Sources (2)
- FDA UDI d7a22992-ea10-4e55-b6ec-ae922265d775 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026