← Back to catalogue
Kono® Gutta Percha Points
EUDAMEDClass IIa (EU MDR)
Ref BP42/30Ref BP42/45Ref BP42/50
Identity
- Trade Name
- Kono® Gutta Percha Points EUDAMED
- Device Name
- Gutta Percha Points EUDAMED
- Model / Reference
- BP42/30 EUDAMEDBP42/45 EUDAMEDBP42/50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069201392 EUDAMED08800069201422 EUDAMED08800069201439 EUDAMED
- Basic UDI-DI
- 880926429GP2D EUDAMED
- Direct Marketing DI
- 08800069201392 EUDAMED08800069201422 EUDAMED08800069201439 EUDAMED
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Kono® Gutta Percha 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sure Dent Corporation
- EUDAMED SRN
- KR-MF-000018662
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 0e3bbee6-2a1e-4503-9c0f-5f52e4f9b138 61 fields · synced Jul 23, 2026
- EUDAMED f3c38fcf-2a9e-4838-a857-d5f83a42f267 61 fields · synced May 18, 2026
- EUDAMED fb40184f-2444-46b7-ab9e-2a784ccba69a 61 fields · synced May 19, 2026