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TotalFill® BC PointsTM Bioceramic Gutta Percha
EUDAMEDClass IIa (EU MDR)
Ref 5023125EURef 5023121EURef 5023133EURef 5023110EURef 5023136EURef 5023123EURef 5023137EURef 5023126EURef 5023118EURef 5023112EURef 5023114EURef 5023113EURef 5023138EURef 5023116EURef 5023131EURef 5023130EU
Identity
- Trade Name
- TotalFill® BC PointsTM Bioceramic Gutta Percha EUDAMED
- Device Name
- Gutta Percha Points EUDAMED
- Model / Reference
- 5023125EU EUDAMED5023121EU EUDAMED5023133EU EUDAMED5023110EU EUDAMED5023136EU EUDAMED5023123EU EUDAMED5023137EU EUDAMED5023126EU EUDAMED5023118EU EUDAMED5023112EU EUDAMED5023114EU EUDAMED5023113EU EUDAMED5023138EU EUDAMED5023116EU EUDAMED5023131EU EUDAMED5023130EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069205161 EUDAMED08800069205123 EUDAMED08800069205246 EUDAMED08800069205017 EUDAMED08800069205277 EUDAMED08800069205147 EUDAMED08800069205284 EUDAMED08800069205178 EUDAMED08800069205093 EUDAMED08800069205031 EUDAMED08800069205055 EUDAMED08800069205048 EUDAMED08800069205291 EUDAMED08800069205079 EUDAMED08800069205222 EUDAMED08800069205215 EUDAMED
- Basic UDI-DI
- 880926429GP2D EUDAMED
- Direct Marketing DI
- 08800069205161 EUDAMED08800069205123 EUDAMED08800069205246 EUDAMED08800069205017 EUDAMED08800069205277 EUDAMED08800069205147 EUDAMED08800069205284 EUDAMED08800069205178 EUDAMED08800069205093 EUDAMED08800069205031 EUDAMED08800069205055 EUDAMED08800069205048 EUDAMED08800069205291 EUDAMED08800069205079 EUDAMED08800069205222 EUDAMED08800069205215 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 EUDAMEDItaly 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 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 (16)
- EUDAMED ce4d8e4d-7ea5-4646-88af-c2a7260483b8 61 fields · synced Aug 4, 2026
- EUDAMED 16bc20f5-2f22-4caf-903e-7151e1422cda 61 fields · synced May 11, 2026
- EUDAMED 1d0f162a-dd88-4100-b1e1-0c3be1534fb2 61 fields · synced May 16, 2026
- EUDAMED a822abdb-6625-47c5-b9c8-3f4242c7ee97 61 fields · synced May 16, 2026
- EUDAMED e3293eb6-3532-4413-9c42-98ffb7072b2b 61 fields · synced May 17, 2026
- EUDAMED ab38f77e-1209-4a6d-a475-2cea3d06e6ba 61 fields · synced May 17, 2026
- EUDAMED 8432c03b-bc2a-4502-a739-e7466a957d73 61 fields · synced May 17, 2026
- EUDAMED c63ba7ed-8d21-4f1f-88c3-84cfd737d6e9 61 fields · synced May 17, 2026
- EUDAMED 148ed5bc-96a2-4794-bd06-83678805c7d0 61 fields · synced May 17, 2026
- EUDAMED a484c0a7-7573-4551-999a-93a11f854c83 61 fields · synced May 18, 2026
- EUDAMED c4b94cc8-6774-4eb4-9e58-c9fadfb9aaaf 61 fields · synced May 18, 2026
- EUDAMED d7f4f505-6d3d-457a-b8e6-defd84da8c83 61 fields · synced May 18, 2026
- EUDAMED aed0a8a1-51a1-4160-9835-c19a47bd12a9 61 fields · synced May 18, 2026
- EUDAMED 84f9972d-7599-4c55-95bb-745c21db97bd 61 fields · synced May 19, 2026
- EUDAMED 0afbf473-5cc6-43d2-b6ea-dc1702bd1b1d 61 fields · synced May 19, 2026
- EUDAMED 7f43d952-13c3-46ae-bc76-f57796193bcb 61 fields · synced May 19, 2026