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EndoSequence® BC PointsTM Bioceramic Gutta Percha
EUDAMEDClass IIa (EU MDR)
Ref 5019510EURef 5023078EURef 5019524EURef 5019521EURef 5019518EURef 5019525EURef 5023077EURef 5019513EURef 5019522EURef 5022679EURef 5019526EURef 5022680EURef 5023076EURef 5019519EU
Identity
- Trade Name
- EndoSequence® BC PointsTM Bioceramic Gutta Percha EUDAMED
- Device Name
- Gutta Percha Points EUDAMED
- Model / Reference
- 5019510EU EUDAMED5023078EU EUDAMED5019524EU EUDAMED5019521EU EUDAMED5019518EU EUDAMED5019525EU EUDAMED5023077EU EUDAMED5019513EU EUDAMED5019522EU EUDAMED5022679EU EUDAMED5019526EU EUDAMED5022680EU EUDAMED5023076EU EUDAMED5019519EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00887919641148 EUDAMED00887919678847 EUDAMED00887919641421 EUDAMED00887919641360 EUDAMED00887919641308 EUDAMED00887919641445 EUDAMED00887919678830 EUDAMED00887919641209 EUDAMED00887919641384 EUDAMED00887919675082 EUDAMED00887919641469 EUDAMED00887919675099 EUDAMED00887919678823 EUDAMED00887919641322 EUDAMED
- Basic UDI-DI
- 880926429GP2D EUDAMED
- Direct Marketing DI
- 00887919641148 EUDAMED00887919678847 EUDAMED00887919641421 EUDAMED00887919641360 EUDAMED00887919641308 EUDAMED00887919641445 EUDAMED00887919678830 EUDAMED00887919641209 EUDAMED00887919641384 EUDAMED00887919675082 EUDAMED00887919641469 EUDAMED00887919675099 EUDAMED00887919678823 EUDAMED00887919641322 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
EndoSequence® BC PointsTM 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 (14)
- EUDAMED f4960d2d-677b-4ea0-87f7-eeb7b43ce763 61 fields · synced Aug 1, 2026
- EUDAMED c84cdf77-72f1-40f7-99f7-519db7a44ee6 61 fields · synced May 16, 2026
- EUDAMED 27e02dbb-f96a-44fa-8949-4e90a2766196 61 fields · synced May 16, 2026
- EUDAMED 3d8ec6c6-9715-4703-9051-0b7a03ddc017 61 fields · synced May 16, 2026
- EUDAMED 6ade5673-48f8-492e-a31a-921184718eb5 61 fields · synced May 17, 2026
- EUDAMED 733005e5-e787-47f3-85e2-929547fcfa67 61 fields · synced May 17, 2026
- EUDAMED c430eb02-8102-4d7c-b5c4-4cad8c000533 61 fields · synced May 17, 2026
- EUDAMED 909ae2b1-dd38-4d90-98f7-06cb6cf8c005 61 fields · synced May 17, 2026
- EUDAMED 46358ea7-383d-48c9-a07a-06f2d9c2a7a0 61 fields · synced May 17, 2026
- EUDAMED 0bd282e7-f86c-43e7-8746-60e4ed050b5c 61 fields · synced May 18, 2026
- EUDAMED aa5adbb6-43c3-4e2a-8cf2-5b9739306ee1 61 fields · synced May 18, 2026
- EUDAMED 9511277f-2e11-46d6-b3dc-2a2679b1f5c0 61 fields · synced May 18, 2026
- EUDAMED 7eb5a06b-849b-4544-a279-a9a0220cfde8 61 fields · synced May 18, 2026
- EUDAMED 9e122196-112c-4b3c-acb5-3886c9ab20b0 61 fields · synced May 19, 2026