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Dentapreg® PINPost Small Refill
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref D-402
by ADM, a.s.
Identity
- Trade Name
- Dentapreg® PINPost Small Refill EUDAMEDDentapreg® PINPost small FDA UDI
- Generic Name
- Dental reinforcing fibre FDA UDI
- Device Name
- Dentapreg® PINPost EUDAMED
- Model / Reference
- D-402 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- D-402 FDA UDI
- Primary DI / UDI-DI
- 08595652700252 EUDAMEDFDA UDI
- Basic UDI-DI
- 85956527PINPostR5 EUDAMED
- 510(k) Number
- K952353 FDA UDI
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q010105 RECONSTRUCTION ENDODONTIC PINS 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® PINPost Small Refill 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 | 85956527PINPostR5 | 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 49d59f9f-48c8-4794-9ac5-b133f2a4bb8f 61 fields · synced Jul 19, 2026
- FDA UDI 7bdc80e3-b719-4a0b-9dbd-e37a82ec94ba 34 fields · synced May 30, 2026