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F360® Guttapercha Points
EUDAMEDClass IIa (EU MDR)
Ref GPF04.000.055Ref GPF04.000.035
Identity
- Trade Name
- F360® Guttapercha Points EUDAMED
- Device Name
- Gutta Percha Points EUDAMED
- Model / Reference
- GPF04.000.055 EUDAMEDGPF04.000.035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069203563 EUDAMED08800069203549 EUDAMED
- Basic UDI-DI
- 880926429GP2D EUDAMED
- Direct Marketing DI
- 08800069203563 EUDAMED08800069203549 EUDAMED
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
F360® Guttapercha Points 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 (2)
- EUDAMED 2a7b6d14-a236-4bfb-bb17-974084cd9a6c 61 fields · synced Jul 15, 2026
- EUDAMED e9826777-9ff9-494c-882a-d45a12bfadec 61 fields · synced May 18, 2026