Identity
- Trade Name
- ZERAMEX® WB Digital Implant Replica EUDAMED
- Device Name
- Accessories for prosthetic restoration EUDAMED
- Model / Reference
- WB37522 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640161393752 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
Category: Dental implant suprastructure, temporary, preformed, single-use
ZERAMEX® WB Digital Implant Replica by CeramTec Schweiz GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
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- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
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 3c44ab93-1a34-4537-a80e-8dd709bb0304 61 fields · synced Jul 27, 2026