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Ceramir Pediatric Crown 71/O Size XL
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 805143
Identity
- Trade Name
- Ceramir Pediatric Crown 71/O Size XL EUDAMEDFDA UDI
- Generic Name
- Custom-made dental crown, polymer FDA UDI
- Device Name
- Pediatric Crown EUDAMED1x Ceramir Pediatric Crown 71/O Size X-Large FDA UDI
- Model / Reference
- 805143 EUDAMEDFDA UDI
- Description
- 1x Ceramir Pediatric Crown 71/O Size X-Large FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09120046326139 EUDAMEDFDA UDI
- Basic UDI-DI
- 912004632PaedCrownNY EUDAMED
- FDA Product Code
- ELZ FDA UDI
- EMDN Code
- Q01020502 PRE-FORMED DENTAL CROWNS EUDAMED
- GMDN Term
- Custom-made dental crown, polymer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3330 FDA UDI
- Market of Registration
- Sweden 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ceramir Pediatric Crown 71/O Size XL by Edelweiss Dentistry Products Gmbh — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 912004632PaedCrownNY | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- edelweiss dentistry products gmbh
- EUDAMED SRN
- AT-MF-000005413
Sources (2)
- EUDAMED df588da0-cab9-4c6d-a3c1-76c0f8e44176 61 fields · synced Jul 17, 2026
- FDA UDI 1d204a28-a75a-4830-ad68-037d641c7c44 33 fields · synced May 29, 2026