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Glass Ionomer Dental Cement
EUDAMEDClass IIa (EU MDR)
Ref GLASS IONOMER DENTAL CEMENT (GKILuting)
Identity
- Trade Name
- Glass Ionomer Dental Cement EUDAMED
- Device Name
- Glass Ionomer Dental Cement EUDAMED
- Model / Reference
- GLASS IONOMER DENTAL CEMENT (GKILuting) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935546103028 EUDAMED
- Basic UDI-DI
- B-06935546103028 EUDAMED
- EMDN Code
- Q01010106 DENTAL RESTORATION GLASS IONOMERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Glass ionomer dental cement
Glass Ionomer Dental Cement by AT&M Biomaterials Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Glass ionomer dental cement.
- Medental Glass Ionomer Type II Restorative — CONAMCO S.A. DE C.V. dba Medental · Class IIa
- 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
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06935546103028 | Class IIa | Active |
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Manufacturer
- Manufacturer
- AT&M Biomaterials Co., Ltd.
- EUDAMED SRN
- CN-MF-000010556
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 39680970-91df-4b87-b542-2e4f4d601063 61 fields · synced Oct 6, 2026