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Septodont Gutta Percha
EUDAMEDClass IIa (EU MDR)
Ref 12842MRef 12841LRef 12840KRef 12850URef 12838IRef 12848SRef 12846QRef 12849TRef 12839JRef 12853XRef 12845P
Identity
- Trade Name
- Septodont Gutta Percha EUDAMED
- Device Name
- Gutta Percha Points EUDAMED
- Model / Reference
- 12842M EUDAMED12841L EUDAMED12840K EUDAMED12850U EUDAMED12838I EUDAMED12848S EUDAMED12846Q EUDAMED12849T EUDAMED12839J EUDAMED12853X EUDAMED12845P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069206526 EUDAMED08800069206519 EUDAMED08800069206502 EUDAMED08800069206601 EUDAMED08800069206489 EUDAMED08800069206588 EUDAMED08800069206564 EUDAMED08800069206595 EUDAMED08800069206496 EUDAMED08800069206632 EUDAMED08800069206557 EUDAMED
- Basic UDI-DI
- 880926429GP2D EUDAMED
- Direct Marketing DI
- 08800069206526 EUDAMED08800069206519 EUDAMED08800069206502 EUDAMED08800069206601 EUDAMED08800069206489 EUDAMED08800069206588 EUDAMED08800069206564 EUDAMED08800069206595 EUDAMED08800069206496 EUDAMED08800069206632 EUDAMED08800069206557 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
Septodont 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 (11)
- EUDAMED dfb1d4a7-ae0b-4d1a-ad11-aa00f89d6f1e 61 fields · synced Aug 3, 2026
- EUDAMED 0cb6f379-c561-48dc-a709-cf4d3a80dd16 61 fields · synced May 17, 2026
- EUDAMED 10695e6b-c720-4c28-a8dd-9c3e27aabfea 61 fields · synced May 17, 2026
- EUDAMED 51891a3f-2877-44c2-b41f-a5dc9e6af7ea 61 fields · synced May 17, 2026
- EUDAMED af2d047a-65dd-4d7d-8c66-9262b5c35965 61 fields · synced May 17, 2026
- EUDAMED 8c931760-a0bb-4a38-b5e8-aeafd96d70eb 61 fields · synced May 18, 2026
- EUDAMED 355ee99d-3aa9-43dd-a81b-110bf5f13dd4 61 fields · synced May 18, 2026
- EUDAMED 1f2094a6-8507-46e0-90c0-ce8ced345d75 61 fields · synced May 18, 2026
- EUDAMED f4bb86e1-187b-46e2-a0a7-f565371c6762 61 fields · synced May 18, 2026
- EUDAMED fd88f88a-4ec7-4934-93d3-ff881a599b9d 61 fields · synced May 18, 2026
- EUDAMED f5a67515-3ddb-4163-99bd-a35decffd729 61 fields · synced May 19, 2026