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Dental Polymer Based Filling and Restorative Materials
EUDAMEDClass IIa (EU MDR)
Ref 001-010Model TF01
Identity
- Device Name
- Dental Polymer Based Filling and Restorative Materials EUDAMED
- Model / Reference
- TF01 EUDAMED001-010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00817441026939 EUDAMED
- Basic UDI-DI
- B-00817441026939 EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental composite resin
Dental Polymer Based Filling and Restorative Materials by Prime Dental Manufacturing — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dental composite resin.
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- 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00817441026939 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Prime Dental Manufacturing
- EUDAMED SRN
- US-MF-000008807
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED 9af5be2b-33b7-49ba-a508-abd621deebba 61 fields · synced Jul 19, 2026