Identity
- Trade Name
- Prime-Dent EUDAMED
- Device Name
- Etchant Gel EUDAMED
- Model / Reference
- 008-010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00817441022818 EUDAMED
- Basic UDI-DI
- 081744102TF8DB EUDAMED
- EMDN Code
- Q01010402 ENAMEL-DENTINAL ETCHING MATERIALS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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
Prime-Dent by Prime Dental Manufacturing — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental etching solution.
- Dento-Etch — Spident · Class IIa
- Vivid TruEtch 10% Kit — PEARSON DENTAL SUPPLIES, INC. · Class II
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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
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 | 081744102TF8DB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Prime Dental Manufacturing
- EUDAMED SRN
- US-MF-000008807
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED 0d845517-6dce-4b89-9a65-2e9b6da2edf7 61 fields · synced May 23, 2026