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Ceramir Pediatric Crown 84/S Size S
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 805172
Identity
- Trade Name
- Ceramir Pediatric Crown 84/S Size S EUDAMEDFDA UDI
- Generic Name
- Custom-made dental crown, polymer FDA UDI
- Device Name
- Pediatric Crown EUDAMED1x Ceramir Pediatric Crown 84/S Size Small FDA UDI
- Model / Reference
- 805172 EUDAMEDFDA UDI
- Description
- 1x Ceramir Pediatric Crown 84/S Size Small FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09120046326429 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 84/S Size S 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 5ae016d1-bada-4f83-b99e-526735758aac 61 fields · synced Jun 18, 2026
- FDA UDI 6ed8a0b2-2501-4526-9d48-f0895ad36653 33 fields · synced May 29, 2026