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Centra® Endo Gutta
EUDAMEDClass IIa (EU MDR)
Ref SD50FFRef SD4935Ref SD4915Ref SD4915-40Ref SD4945Ref SD4945-80Ref SD50LRef SD4970Ref SD50XFRef SD4940Ref SD4920Ref SD50MFRef SD4980
Identity
- Trade Name
- Centra® Endo Gutta EUDAMED
- Device Name
- Gutta Percha Points EUDAMED
- Model / Reference
- SD50FF EUDAMEDSD4935 EUDAMEDSD4915 EUDAMEDSD4915-40 EUDAMEDSD4945 EUDAMEDSD4945-80 EUDAMEDSD50L EUDAMEDSD4970 EUDAMEDSD50XF EUDAMEDSD4940 EUDAMEDSD4920 EUDAMEDSD50MF EUDAMEDSD4980 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069201750 EUDAMED08800069201644 EUDAMED08800069201606 EUDAMED08800069201729 EUDAMED08800069201668 EUDAMED08800069201736 EUDAMED08800069201811 EUDAMED08800069201705 EUDAMED08800069201743 EUDAMED08800069201651 EUDAMED08800069201613 EUDAMED08800069201767 EUDAMED08800069201712 EUDAMED
- Basic UDI-DI
- 880926429GP2D EUDAMED
- Direct Marketing DI
- 08800069201750 EUDAMED08800069201644 EUDAMED08800069201606 EUDAMED08800069201729 EUDAMED08800069201668 EUDAMED08800069201736 EUDAMED08800069201811 EUDAMED08800069201705 EUDAMED08800069201743 EUDAMED08800069201651 EUDAMED08800069201613 EUDAMED08800069201767 EUDAMED08800069201712 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
Centra® Endo Gutta 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 (13)
- EUDAMED 6a5bc4db-ca21-4267-b017-2b54e015769a 61 fields · synced Sep 18, 2026
- EUDAMED a5498898-5e21-4244-a30f-b22ba6cd58ec 61 fields · synced May 16, 2026
- EUDAMED 93274691-e735-4810-9ecb-6d6dfb453082 61 fields · synced May 16, 2026
- EUDAMED 33328507-07d1-467b-a863-21adb3ef52f7 61 fields · synced May 17, 2026
- EUDAMED 1c34265a-5a9f-48b5-b493-46b86c057f94 61 fields · synced May 17, 2026
- EUDAMED 0359c615-0774-4608-b3e5-97f4416a1c51 61 fields · synced May 18, 2026
- EUDAMED 1e370540-b340-4101-9461-55b27aef602b 61 fields · synced May 18, 2026
- EUDAMED 6990af48-0315-4008-ad6a-b91feb65f842 61 fields · synced May 18, 2026
- EUDAMED 2cb1ae6e-cd9a-4f2b-924e-88aef70c85bf 61 fields · synced May 18, 2026
- EUDAMED 3f89e4c0-81fc-4926-83bf-13ecf508a2e1 61 fields · synced May 18, 2026
- EUDAMED 1888067d-1b9b-40cf-8ab8-34deb74f87c2 61 fields · synced May 18, 2026
- EUDAMED be11fa93-175a-4635-9c19-2049110aa104 61 fields · synced May 19, 2026
- EUDAMED 9e41ed4a-4ecd-4ae2-8191-53865ab6d06f 61 fields · synced May 19, 2026