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ODUS - Pella Transparent Crown Forms - N°201 - Box of 6 pairs
EUDAMEDFDA UDIClass I (EU MDR)
Ref 33751d
Identity
- Trade Name
- ODUS - Pella Transparent Crown Forms - N°201 - Box of 6 pairs EUDAMEDODUS "PELLA" Transparent CROWN FORMS - Box of 12 crowns - R/L 201 FDA UDI
- Generic Name
- Preformed dental crown, temporary FDA UDI
- Device Name
- Pella Transparent Crown Forms - N°1 - Box of 6 pairs EUDAMED6 pairs (right and left) of size N°201 as described in the crown form chart FDA UDI
- Model / Reference
- 33751d EUDAMEDFDA UDI
- Description
- 6 pairs (right and left) of size N°201 as described in the crown form chart FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640159160809 EUDAMEDFDA UDI
- Basic UDI-DI
- 764015916PELLADY EUDAMED
- FDA Product Code
- ELZ FDA UDI
- EMDN Code
- Q01020502 PRE-FORMED DENTAL CROWNS EUDAMED
- GMDN Term
- Preformed dental crown, temporary FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3330 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
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
ODUS - Pella Transparent Crown Forms - N°201 - Box of 6 pairs by Produits Dentaires SA — Class I — 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 | 764015916PELLADY | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Produits Dentaires SA
- EUDAMED SRN
- CH-MF-000023147
- Authorised Representative
- PD DENTAL EU SAS FR-AR-000017144
Sources (2)
- EUDAMED 95d8325b-2130-42df-97c5-dd4fb53c955e 61 fields · synced Sep 17, 2026
- FDA UDI b6b44b90-b3c8-44da-b35d-dfb8940351ae 34 fields · synced May 30, 2026