Identity
- Trade Name
- Q-GLASS, Shade A2 EUDAMED
- Device Name
- Glass Ionomer Cements EUDAMED
- Model / Reference
- 100030GRC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290115053463 EUDAMED
- Basic UDI-DI
- 72901150510003093 EUDAMED
- EMDN Code
- Q01010106 DENTAL RESTORATION GLASS IONOMERS 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: Glass ionomer dental cement
Q-GLASS, Shade A2 by B.J.M. Laboratories Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Glass ionomer dental cement.
- 3M™ Ketac™ Fil Plus Aplicap™ — 3M Deutschland GmbH · Class II
- KETAC™ — 3M COMPANY · Class II
- Ketac™ Cem radiopaque — 3M Deutschland GmbH · Class II
- Vitremer™ — 3M COMPANY · Class II
- SciPharm Until Temporary Crown and Bridge Cement — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
- Precedent — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
- Vivid Glass Restorative A2 Std Pkg — PEARSON DENTAL SUPPLIES, INC. · Class II
- GC Fuji II LC® — 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 | 72901150510003093 | 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 602870b3-cd5c-44cd-b810-9784ea663f05 61 fields · synced Jun 18, 2026