Identity
- Trade Name
- Etching Gel 3ml x 3 EUDAMED
- Device Name
- Dental Etchant EUDAMED
- Model / Reference
- 130101008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05206569006339 EUDAMED
- Basic UDI-DI
- 5206569COTH51SL EUDAMED
- EMDN Code
- Q01010402 ENAMEL-DENTINAL ETCHING MATERIALS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece 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 etching solution
Etching Gel 3ml x 3 by DMP Dental Industry S.A. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dental etching solution.
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- ETCHANT — Pulpdent Corporation · Class II
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- GC CERAMIC PRIMER II — Gc America Inc. · 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 | 5206569COTH51SL | Class IIa | Active |
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Manufacturer
- Manufacturer
- DMP Dental Industry S.A.
- EUDAMED SRN
- GR-MF-000019283
Sources (1)
- EUDAMED 91b37099-0d5b-45b2-8cc7-50d91e0c9ebb 61 fields · synced Jun 18, 2026