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edelweiss PEDIATRIC CROWN 63/H Size S
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 17208
Identity
- Trade Name
- edelweiss PEDIATRIC CROWN 63/H Size S EUDAMEDFDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Pediatric Crown EUDAMED1x edelweiss Pediatric Crown 63/H Size Small FDA UDI
- Model / Reference
- 17208 EUDAMEDFDA UDI
- Description
- 1x edelweiss Pediatric Crown 63/H Size Small FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09120046323541 EUDAMEDFDA UDI
- Basic UDI-DI
- 912004632PaedCrownNY EUDAMED
- FDA Product Code
- ELZ FDA UDI
- EMDN Code
- Q01020502 PRE-FORMED DENTAL CROWNS EUDAMED
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3330 FDA UDI
- Market of Registration
- Austria 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
edelweiss PEDIATRIC CROWN 63/H 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 034ff67a-2af2-4c08-b5d9-1c3b77abb41a 61 fields · synced Jul 19, 2026
- FDA UDI 70834a52-7c2d-4019-8465-a4d33ebef185 33 fields · synced May 29, 2026