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TotalFill® BC PointsTM 150 Series Bioceramic Gutta Percha
EUDAMEDClass IIa (EU MDR)
Ref 5027286EURef 5027291EURef 5027290EURef 5027284EU
Identity
- Trade Name
- TotalFill® BC PointsTM 150 Series Bioceramic Gutta Percha EUDAMED
- Device Name
- Gutta Percha Points EUDAMED
- Model / Reference
- 5027286EU EUDAMED5027291EU EUDAMED5027290EU EUDAMED5027284EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069205376 EUDAMED08800069205420 EUDAMED08800069205413 EUDAMED08800069205352 EUDAMED
- Basic UDI-DI
- 880926429GP2D EUDAMED
- Direct Marketing DI
- 08800069205376 EUDAMED08800069205420 EUDAMED08800069205413 EUDAMED08800069205352 EUDAMED
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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
TotalFill® BC PointsTM 150 Series Bioceramic Gutta Percha by Sure Dent Corporation — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 880926429GP2D | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sure Dent Corporation
- EUDAMED SRN
- KR-MF-000018662
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (4)
- EUDAMED f956f013-f6bf-49f1-8727-c42e1d2bfdb6 61 fields · synced Jul 27, 2026
- EUDAMED 87859d8b-e584-4e9e-81da-5abb9daa4d24 61 fields · synced May 18, 2026
- EUDAMED e3115dde-ca06-414c-b5d4-a7200c5e6b9e 61 fields · synced May 18, 2026
- EUDAMED 71fb02fd-ab43-4896-ab27-ef5d6034de7c 61 fields · synced May 18, 2026