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Exotec Pointes de Gutta Percha, ISO Color, ISO Taper
EUDAMEDClass IIa (EU MDR)
Ref EN02630Ref EN02625Ref EN02440Ref EN02425Ref EN02025Ref EN02620Ref EN02435Ref EN02635
Identity
- Trade Name
- Exotec Pointes de Gutta Percha, ISO Color, ISO Taper EUDAMED
- Device Name
- Gutta Percha Points EUDAMED
- Model / Reference
- EN02630 EUDAMEDEN02625 EUDAMEDEN02440 EUDAMEDEN02425 EUDAMEDEN02025 EUDAMEDEN02620 EUDAMEDEN02435 EUDAMEDEN02635 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069210943 EUDAMED08800069210936 EUDAMED08800069210912 EUDAMED08800069210882 EUDAMED08800069210851 EUDAMED08800069210929 EUDAMED08800069210905 EUDAMED08800069210950 EUDAMED
- Basic UDI-DI
- 880926429GP2D EUDAMED
- Direct Marketing DI
- 08800069210943 EUDAMED08800069210936 EUDAMED08800069210912 EUDAMED08800069210882 EUDAMED08800069210851 EUDAMED08800069210929 EUDAMED08800069210905 EUDAMED08800069210950 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
Exotec Pointes de Gutta Percha, ISO Color, ISO Taper 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 (8)
- EUDAMED d9a03775-c5d3-4ca0-a84f-9e86627947f7 61 fields · synced Aug 1, 2026
- EUDAMED 09e2b12b-0d1d-40f7-8bf3-a3e40e5f1390 61 fields · synced May 11, 2026
- EUDAMED cf91c56f-d234-4351-ac89-acdebe4ca6e1 61 fields · synced May 16, 2026
- EUDAMED 67640756-6209-42fb-9494-851061c1c1ce 61 fields · synced May 17, 2026
- EUDAMED 1fc8e54f-1c46-4b23-809d-bec0bfaaa678 61 fields · synced May 17, 2026
- EUDAMED 664b1150-1c39-49e8-bc6e-957280ea4e9e 61 fields · synced May 18, 2026
- EUDAMED bb2eccac-8c1c-4c96-b6b0-7c040af19411 61 fields · synced May 18, 2026
- EUDAMED 1c213581-8df0-475e-a335-ad144ca4faa1 61 fields · synced May 19, 2026