Identity
- Trade Name
- Tenex Modelling Wax 5 lb (Kemdent) EUDAMED
- Device Name
- Dental Modelling (Baseplate) Wax EUDAMED
- Model / Reference
- WAX899S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05021752007036 EUDAMED
- Basic UDI-DI
- 5021752MODWAX0134808FF EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Tenex Modelling Wax 5 lb (Kemdent) by Associated Dental Products Ltd — 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 | 5021752MODWAX0134808FF | Class I | Active |
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Manufacturer
- Manufacturer
- Associated Dental Products Ltd
- EUDAMED SRN
- GB-MF-000003673
- Authorised Representative
- Kemdent Limited IE-AR-000001930
Sources (1)
- EUDAMED 3c1dfe2a-90cc-464d-b035-cc1a7830bc84 61 fields · synced Jun 18, 2026