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Direct Bioceramic Gutta Percha
EUDAMEDClass IIa (EU MDR)
Ref 200044Ref 200035Ref 200046Ref 200048Ref 200041Ref 200045Ref 200039Ref 200029Ref 200037Ref 200042Ref 200030Ref 200038Ref 200034Ref 200033Ref 200036Ref 200050
Identity
- Trade Name
- Direct Bioceramic Gutta Percha EUDAMED
- Device Name
- Gutta Percha Points EUDAMED
- Model / Reference
- 200044 EUDAMED200035 EUDAMED200046 EUDAMED200048 EUDAMED200041 EUDAMED200045 EUDAMED200039 EUDAMED200029 EUDAMED200037 EUDAMED200042 EUDAMED200030 EUDAMED200038 EUDAMED200034 EUDAMED200033 EUDAMED200036 EUDAMED200050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069206205 EUDAMED08800069206113 EUDAMED08800069206229 EUDAMED08800069206243 EUDAMED08800069206175 EUDAMED08800069206212 EUDAMED08800069206151 EUDAMED08800069206052 EUDAMED08800069206137 EUDAMED08800069206182 EUDAMED08800069206069 EUDAMED08800069206144 EUDAMED08800069206106 EUDAMED08800069206090 EUDAMED08800069206120 EUDAMED08800069206267 EUDAMED
- Basic UDI-DI
- 880926429GP2D EUDAMED
- Direct Marketing DI
- 08800069206205 EUDAMED08800069206113 EUDAMED08800069206229 EUDAMED08800069206243 EUDAMED08800069206175 EUDAMED08800069206212 EUDAMED08800069206151 EUDAMED08800069206052 EUDAMED08800069206137 EUDAMED08800069206182 EUDAMED08800069206069 EUDAMED08800069206144 EUDAMED08800069206106 EUDAMED08800069206090 EUDAMED08800069206120 EUDAMED08800069206267 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
Direct Bioceramic 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 (16)
- EUDAMED e52b9687-f989-4da9-b304-26afc922010a 61 fields · synced Aug 4, 2026
- EUDAMED 27d5e317-009c-4f6d-b49e-f643abbb450e 61 fields · synced May 17, 2026
- EUDAMED a063b046-cbf0-461c-9c02-065e6485a51c 61 fields · synced May 17, 2026
- EUDAMED cf26d931-418e-48cb-b39d-857a1033953a 61 fields · synced May 17, 2026
- EUDAMED 66b58c42-4f86-4467-a884-a5719184bf8a 61 fields · synced May 17, 2026
- EUDAMED 17fe2301-5426-419c-9483-6b304a5d922a 61 fields · synced May 17, 2026
- EUDAMED bf30e678-bec1-4e4f-a413-32f53440eb56 61 fields · synced May 18, 2026
- EUDAMED 51e46582-3256-4708-91fc-0d9a8dbc7a52 61 fields · synced May 18, 2026
- EUDAMED 14b60b6e-14df-45e0-babc-79edc6c23813 61 fields · synced May 18, 2026
- EUDAMED a4491980-1a20-4549-ac29-d58f3ca99bb9 61 fields · synced May 18, 2026
- EUDAMED aee0c3f3-e351-4e74-9f62-785f8fd482cf 61 fields · synced May 18, 2026
- EUDAMED 7763d6f3-5579-4d3a-8c5c-68272beeeaa0 61 fields · synced May 18, 2026
- EUDAMED 16818b58-5645-495c-9f77-5dc1ee879726 61 fields · synced May 18, 2026
- EUDAMED f824a8a3-03c4-42e8-97bc-6d34b0ea98e8 61 fields · synced May 18, 2026
- EUDAMED 7a2f1b29-964c-47ba-8ec9-79f8ac5437bb 61 fields · synced May 18, 2026
- EUDAMED 36b8e0d7-b83b-4214-861d-aaa07cf72e20 61 fields · synced May 19, 2026