← Back to catalogue
Medental Glass Ionomer Type II Restorative
EUDAMEDClass IIa (EU MDR)
Ref 0PT393Model Glass IonomerRef 0PT392
Identity
- Trade Name
- Medental Glass Ionomer Type II Restorative EUDAMED
- Device Name
- Glass Ionomer EUDAMED
- Model / Reference
- Glass Ionomer EUDAMED0PT393 EUDAMED0PT392 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07502291840189 EUDAMED07502291840172 EUDAMED
- Basic UDI-DI
- 750229184268828 EUDAMED
- Direct Marketing DI
- 07502291840189 EUDAMED07502291840172 EUDAMED
- EMDN Code
- Q01010106 DENTAL RESTORATION GLASS IONOMERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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
Medental Glass Ionomer Type II Restorative by CONAMCO S.A. DE C.V. dba Medental — 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 | 750229184268828 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CONAMCO S.A. DE C.V. dba Medental
- EUDAMED SRN
- MX-MF-000020252
- Authorised Representative
- Ivonne Richaud ES-AR-000017547
Sources (2)
- EUDAMED 9ef54f9f-9b12-4a13-9745-c5da99c28879 61 fields · synced Jul 15, 2026
- EUDAMED 6cc1e3ec-4c26-431f-9398-8028a9d4b7d4 61 fields · synced May 17, 2026