← Back to catalogue
Glass Ionomer Lining Cement 10g powder / 5mL Liquid
EUDAMEDClass IIa (EU MDR)
Ref 061XPL
Identity
- Trade Name
- Glass Ionomer Lining Cement 10g powder / 5mL Liquid EUDAMED
- Device Name
- LC-RMGI Base Liner/ Calcium Hydroxide Base Liner/ Bulk Flow Composite EUDAMED
- Model / Reference
- 061XPL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056009101489 EUDAMED
- Basic UDI-DI
- 5056009120275SU EUDAMED
- EMDN Code
- Q0101010201 DENTAL BASE CEMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Malta 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 composite resin
Glass Ionomer Lining Cement 10g powder / 5mL Liquid by Advanced Healthcare Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental composite resin.
- Name: Light Curing Composite Model: Flow — Micerium S.p.A. · Class IIa
- Forma S — ULTRADENT PRODUCTS, INC. · Class II
- NovaPro Fill — NANOVA BIOMATERIALS INC · Class II
- SimpliShade — KERR CORPORATION · Class II
- Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
- Llis — Dentscare Ltda · Class II
- Capo Universal, 6 g — Schütz Dental GmbH · Class II
- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · 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 | 5056009120275SU | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advanced Healthcare Ltd.
- EUDAMED SRN
- GB-MF-000002771
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED d93c1039-9e7e-4f96-b095-1e0558d1bdd3 61 fields · synced Jul 17, 2026