Identity
- Trade Name
- i-FIX Plus EUDAMEDi-FIX EUDAMED
- Device Name
- Resin Modified Glass Ionomer Luting Cement EUDAMEDGlass Ionomer Luting Cement EUDAMED
- Model / Reference
- IIXPL EUDAMEDIIXPT EUDAMEDIIXTL EUDAMEDIIXSTP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04772178004284 EUDAMED04772178004260 EUDAMED04772178004376 EUDAMED04772178006677 EUDAMED
- Basic UDI-DI
- 4772178ML-RMGILCFF EUDAMED4772178ML-GILCUR EUDAMED
- EMDN Code
- Q01010106 DENTAL RESTORATION GLASS IONOMERS EUDAMEDQ0101010299 TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Lithuania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMEDEUDAMED
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
i-FIX Plus by UAB "Medicinos linija" — 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
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- 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 | 4772178ML-RMGILCFF | Class IIa | Active |
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Manufacturer
- Manufacturer
- UAB "Medicinos linija"
- EUDAMED SRN
- LT-MF-000002719
Sources (4)
- EUDAMED 0fb69eb5-be63-4abc-a84e-5628c8ee418a 61 fields · synced Oct 6, 2026
- EUDAMED ebce6b6b-b02d-47d5-9db5-abddff2d4981 61 fields · synced May 17, 2026
- EUDAMED 283ea16e-7ea3-458b-813b-2b8b771525c2 61 fields · synced May 17, 2026
- EUDAMED 05da26f7-a69a-4361-8a00-e31d230300f4 61 fields · synced May 18, 2026