Identity
- Trade Name
- SICwhite Lab Screw SB/RB/WB EUDAMED
- Device Name
- Accessories for prosthetic restoration EUDAMED
- Model / Reference
- 970472 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640161395572 EUDAMED
- Basic UDI-DI
- 764016139XB3YYYYK01IPET EUDAMED
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
SICwhite Lab Screw SB/RB/WB by CeramTec Schweiz GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764016139XB3YYYYK01IPET | Class I | Active |
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Manufacturer
- Manufacturer
- CeramTec Schweiz GmbH
- EUDAMED SRN
- CH-MF-000024169
- Authorised Representative
- CeramTec Dentalvertriebs GmbH DE-AR-000020220
Sources (1)
- EUDAMED 5d0746a5-4e14-4011-bf22-d2da94c1b372 61 fields · synced Jun 20, 2026