Identity
- Trade Name
- ELEPHANDENS EUDAMED
- Model / Reference
- Artificial Teeth EUDAMEDM8C3S6S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435288487144 EUDAMED
- Basic UDI-DI
- 084352884UD-TEETHVS EUDAMED
- EMDN Code
- Q01020601,Q01020602,Q01020603,Q01020605 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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: Resin artificial teeth
This medical device, ELEPHANDENS, is a Class IIa artificial teeth implant used for the replacement of missing or damaged teeth in patients. It is manufactured by UNION DENTAL S.A. and has been approved by regulatory authorities worldwide.
Similar devices
Also classified as Resin artificial teeth.
- Resin Teeth / DCL / PE — IVOCLAR VIVADENT AKTIENGESELLSCHAFT · Class II
- Candulor NFC+ — Candulor AG · Class II
- Physioset TCR 6er — Candulor AG · Class II
- Portrait® IPN® Anteriors — Dentsply International · Class II
- artegral life — Merz Dental GmbH · Class II
- Mondial 8i, D4 / M, CE — Kulzer, Inc. · Class II
- Monarch — Wright Health Group , Ltd. · Class II
- Ref-Line — POLIDENT d.o.o. · Class II
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 | 084352884UD-TEETHVS | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Union Dental S.a.
- EUDAMED SRN
- ES-MF-000003189
Sources (1)
- EUDAMED 842a7dd4-f1e4-4a4b-aade-899fa651e9a2 61 fields · synced Aug 1, 2026