Identity
- Trade Name
- i-FIL EUDAMED
- Device Name
- Glass ionomer filling cement EUDAMED
- Model / Reference
- IFITP EUDAMEDIFIA3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04772178003935 EUDAMED04772178004024 EUDAMED
- Basic UDI-DI
- 4772178ML06GICRP EUDAMED
- EMDN Code
- Q01010106 DENTAL RESTORATION GLASS IONOMERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Lithuania 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
i-FIL by UAB "Medicinos linija" — Class IIa — MDR — 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4772178ML06GICRP | Class IIa | Active |
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Manufacturer
- Manufacturer
- UAB "Medicinos linija"
- EUDAMED SRN
- LT-MF-000002719
Sources (2)
- EUDAMED 7155f4c0-c64f-4855-b890-387935e2bb79 61 fields · synced Oct 6, 2026
- EUDAMED 5187757c-0e42-4364-b71d-ef201560d238 61 fields · synced May 17, 2026