Identity
- Trade Name
- Dentalica Precision Axia Etch EUDAMED
- Device Name
- Tooth Surface Treatments EUDAMED
- Model / Reference
- PR0010ETD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057502150094 EUDAMED
- Basic UDI-DI
- 7290115051000909M 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
Dentalica Precision Axia Etch by B.J.M. Laboratories Ltd. — 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
- DC Keramik Ätzgel — PRISMAN GmbH · Class I
- MASTER-DENT — DENTONICS, INC.
- OSE 8oz. Orthodontic Etching Gel - Blue — ORTHODONTIC SUPPLY & EQUIPMENT CO., INC. · Class II
- 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 | 7290115051000909M | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- B.J.M. Laboratories Ltd.
- EUDAMED SRN
- IL-MF-000034121
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 58b3d3c9-2a45-478f-8aa3-013bb62c2400 61 fields · synced Jun 19, 2026