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Dentapreg® SFM Splinting
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref D-501
by ADM, a.s.
Identity
- Trade Name
- Dentapreg® SFM Splinting EUDAMEDFDA UDI
- Generic Name
- Dental reinforcing fibre FDA UDI
- Device Name
- Dentapreg® SFM EUDAMED
- Model / Reference
- D-501 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- D-501 FDA UDI
- Primary DI / UDI-DI
- 08595652700283 EUDAMEDFDA UDI
- Basic UDI-DI
- 85956527SFM9H EUDAMED
- 510(k) Number
- K952353 FDA UDI
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Dental reinforcing fibre FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Market of Registration
- Czechia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Dentapreg® SFM Splinting by ADM, a.s. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 85956527SFM9H | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- ADM, a.s.
- EUDAMED SRN
- CZ-MF-000032589
Sources (2)
- EUDAMED 8f70e5f4-178f-452c-a878-c3372944b155 61 fields · synced Aug 3, 2026
- FDA UDI c55bef63-3407-40fd-86b1-c1508a3fb799 34 fields · synced May 30, 2026