Identity
- Trade Name
- Tfil eco Temporary Cavity Filling Material EUDAMEDTFilEco FDA UDI
- Generic Name
- Hygroscopic dental cement FDA UDI
- Device Name
- OTC Temporary Filling Material / High Viscosity Temporary Filling Material EUDAMEDTemp Filling Mat Eco 35g Jar FDA UDI
- Model / Reference
- AH1020 EUDAMEDFDA UDI
- Description
- Temp Filling Mat Eco 35g Jar FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060446605400 EUDAMEDFDA UDI
- Basic UDI-DI
- 5056009120121RY EUDAMED
- FDA Product Code
- EMA FDA UDI
- EMDN Code
- Q0101010203 TEMPORARY DENTAL CEMENTS EUDAMED
- GMDN Term
- Hygroscopic 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
Yes
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: Hygroscopic dental cement
TFilEco by Advanced Healthcare Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Hygroscopic dental cement.
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- AH Plus BioCermanic Sealer — TULSA DENTAL PRODUCTS LLC · 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 9d7aa0aa-922a-4a2a-b75d-cdb9700731c3 34 fields · synced Aug 4, 2026
- EUDAMED 83452b2e-f76b-4b99-b03c-71a413046d2e 61 fields · synced Aug 4, 2026