Identity
- Trade Name
- DC Keramik Ätzgel EUDAMED
- Device Name
- Keramik Ätzgel HF-Etch EUDAMED
- Model / Reference
- 360 EUDAMED716050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04064797027691 EUDAMED
- Basic UDI-DI
- ++EPRM360DZ EUDAMED
- EMDN Code
- Q01010402 ENAMEL-DENTINAL ETCHING MATERIALS 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 etching solution
DC Keramik Ätzgel by PRISMAN GmbH — Class I — 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
- Scotchbond™ Universal — 3M Deutschland GmbH · Class II
- GC CERAMIC PRIMER II — Gc America Inc. · Class II
- Etching Gel 2ml — DMP Dental Industry S.A. · Class IIa
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 | ++EPRM360DZ | Class I | Active |
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Manufacturer
- Manufacturer
- PRISMAN GmbH
- EUDAMED SRN
- DE-MF-000009900
Sources (1)
- EUDAMED 5eeea1cb-fe82-430c-8805-08ba54acd029 61 fields · synced Jul 11, 2026