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Bio GP Points
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref G906 LBR50Ref G906 B25.04Ref G906 LBF2Ref G906 BF1-F3
Identity
- Trade Name
- Bio GP Points EUDAMEDSure-endo FDA UDI
- Generic Name
- Synthetic gutta-percha FDA UDI
- Device Name
- Gutta Percha Points EUDAMEDGutta Percha Points, Size F1F2F3, 60/PK FDA UDI
- Model / Reference
- G906 LBR50 EUDAMEDG906 B25.04 EUDAMEDG906 LBF2 EUDAMEDG906 BF1-F3 EUDAMED10F12300 FDA UDI
- Description
- Gutta Percha Points, Size F1F2F3, 60/PK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809264292563 EUDAMED08809264291719 EUDAMED08809264292310 EUDAMED08809264292235 EUDAMEDFDA UDI
- Basic UDI-DI
- 880926429GP2D EUDAMED
- Direct Marketing DI
- 08809264292563 EUDAMED08809264291719 EUDAMED08809264292310 EUDAMED08809264292235 EUDAMED
- FDA Product Code
- EKM FDA UDI
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
- GMDN Term
- Synthetic gutta-percha FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3850 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Bio GP Points by Sure Dent Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880926429GP2D | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Sure Dent Corporation
- EUDAMED SRN
- KR-MF-000018662
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (5)
- EUDAMED 857a8058-53dc-4b80-a2b0-465d02382cda 61 fields · synced Jul 22, 2026
- EUDAMED 39e7a9c1-2bda-4fb0-a152-2c02f51f7f8b 61 fields · synced May 18, 2026
- EUDAMED c41f3a72-40e3-40c4-b110-fde0ea5145fa 61 fields · synced May 19, 2026
- EUDAMED 0b17f01b-7c69-42c8-896f-ea7934a4fcf5 61 fields · synced May 19, 2026
- FDA UDI cc8670a3-e31a-4e7d-bdf4-27727a4e8d36 34 fields · synced May 30, 2026