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EdgeOne Fire Gutta Percha Points
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref EOFPRIGP-1
Identity
- Trade Name
- EdgeOne Fire Gutta Percha Points EUDAMEDEdge One Fire GP FDA UDI
- Generic Name
- Synthetic gutta-percha FDA UDI
- Device Name
- Gutta Percha Points EUDAMEDEdgeOne Fire Gutta Percha Points PRI FDA UDI
- Model / Reference
- EOFPRIGP-1 EUDAMEDFDA UDI
- Description
- EdgeOne Fire Gutta Percha Points PRI FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800069209466 EUDAMEDFDA UDI
- Basic UDI-DI
- 880926429GP2D EUDAMED
- Direct Marketing DI
- 08800069209466 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
EdgeOne Fire Gutta Percha 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 (2)
- EUDAMED 42fdcd0d-f34b-457f-b132-1d001baf50c4 61 fields · synced Jul 10, 2026
- FDA UDI 91b1692e-a32a-4c72-8ba2-c2c7fea122e8 34 fields · synced May 30, 2026