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Septaline Endodontie Gutta Ponts, Color-End-Gutta, ISO-Taper, Vario-Taper
EUDAMEDClass IIa (EU MDR)
Ref PL-SEP-33E.0015Ref PL-SEP-33E.06ASPRef PL-SEP-33E.0615Ref PL-SEP-33E.0620Ref PL-SEP-33E.0040Ref PL-SEP-33E.0630Ref PL-SEP-33E.0430Ref PL-SEP-33E.0020Ref PL-SEP-33E.0625Ref PL-SEP-33E.0420Ref PL-SEP-33E.0415Ref PL-SEP-33E.0035
Identity
- Trade Name
- Septaline Endodontie Gutta Ponts, Color-End-Gutta, ISO-Taper, Vario-Taper EUDAMED
- Device Name
- Gutta Percha Points EUDAMED
- Model / Reference
- PL-SEP-33E.0015 EUDAMEDPL-SEP-33E.06ASP EUDAMEDPL-SEP-33E.0615 EUDAMEDPL-SEP-33E.0620 EUDAMEDPL-SEP-33E.0040 EUDAMEDPL-SEP-33E.0630 EUDAMEDPL-SEP-33E.0430 EUDAMEDPL-SEP-33E.0020 EUDAMEDPL-SEP-33E.0625 EUDAMEDPL-SEP-33E.0420 EUDAMEDPL-SEP-33E.0415 EUDAMEDPL-SEP-33E.0035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069210370 EUDAMED08800069210615 EUDAMED08800069210547 EUDAMED08800069210554 EUDAMED08800069210424 EUDAMED08800069210578 EUDAMED08800069210486 EUDAMED08800069210387 EUDAMED08800069210561 EUDAMED08800069210462 EUDAMED08800069210455 EUDAMED08800069210417 EUDAMED
- Basic UDI-DI
- 880926429GP2D EUDAMED
- Direct Marketing DI
- 08800069210370 EUDAMED08800069210615 EUDAMED08800069210547 EUDAMED08800069210554 EUDAMED08800069210424 EUDAMED08800069210578 EUDAMED08800069210486 EUDAMED08800069210387 EUDAMED08800069210561 EUDAMED08800069210462 EUDAMED08800069210455 EUDAMED08800069210417 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
Septaline Endodontie Gutta Ponts, Color-End-Gutta, ISO-Taper, Vario-Taper by Sure Dent Corporation — Class IIa — MDR — listed in EUDAMED
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 (12)
- EUDAMED b451fdf5-f911-4f24-8772-111df75289a0 61 fields · synced Oct 5, 2026
- EUDAMED 01573ec9-e0d6-4f60-bda3-bb57d75ad4e9 61 fields · synced May 16, 2026
- EUDAMED 15dbdb40-d77d-4600-b594-8a9507898bb5 61 fields · synced May 17, 2026
- EUDAMED f62aae9f-5367-49f2-9534-185df84a9e50 61 fields · synced May 17, 2026
- EUDAMED 6f594e01-dc4e-4b8b-a9c7-8ac0ca220eaa 61 fields · synced May 18, 2026
- EUDAMED 25f65b6b-624b-4a89-b70c-e182b36d6e20 61 fields · synced May 18, 2026
- EUDAMED 0fe53f40-57aa-4202-97e2-0c4be9f2478a 61 fields · synced May 18, 2026
- EUDAMED 707bf17d-e5ef-4d4b-89b8-241424972381 61 fields · synced May 18, 2026
- EUDAMED 75f35187-6dc8-457a-846c-7625fabb6bfe 61 fields · synced May 18, 2026
- EUDAMED f9d37aba-facb-45fd-8059-8c260807c4ea 61 fields · synced May 18, 2026
- EUDAMED 7dddea17-7421-4a24-a6a4-f33229a455ee 61 fields · synced May 18, 2026
- EUDAMED c631b5bd-9aca-46b6-9389-6d2d1a6c9199 61 fields · synced May 18, 2026