Identity
- Trade Name
- AHfil Anterior Glass Ionomer Restorative Material Shade A3.5 EUDAMEDAHfil FDA UDI
- Generic Name
- Glass ionomer dental cement FDA UDI
- Device Name
- Composite Resin Restorative EUDAMEDGI Aest Rest Cem 15g/7ml A3.5 FDA UDI
- Model / Reference
- AH0004 EUDAMEDFDA UDI
- Description
- GI Aest Rest Cem 15g/7ml A3.5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060446600030 EUDAMEDFDA UDI
- Basic UDI-DI
- 5056009120152SB EUDAMED
- FDA Product Code
- EMA FDA UDI
- EMDN Code
- Q01010106 DENTAL RESTORATION GLASS IONOMERS EUDAMED
- GMDN Term
- Glass ionomer dental cement FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3275 FDA UDI
- Market of Registration
- Malta EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glass ionomer dental cement
AHfil by Advanced Healthcare Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Glass ionomer dental cement.
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- 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Advanced Healthcare Ltd.
Sources (2)
- FDA UDI f68d263d-f5c8-4cb1-8a16-0a17525809fe 34 fields · synced Jul 11, 2026
- EUDAMED 9bc639e8-2fa3-4749-9266-1760b97bf379 61 fields · synced Jul 11, 2026