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PlanBDental® minikut® Paper Points
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1670520
Identity
- Trade Name
- PlanBDental® minikut® Paper Points EUDAMEDMinikut FDA UDI
- Generic Name
- Endodontic paper point FDA UDI
- Device Name
- Sterile Absorbent Paper Points EUDAMEDAbsorbent Paper Points Taper .05, Size 20, 100/PK, mm marked, SB FDA UDI
- Model / Reference
- 1670520 EUDAMEDP910 L20.05 FDA UDI
- Description
- Absorbent Paper Points Taper .05, Size 20, 100/PK, mm marked, SB FDA UDI
Identifiers
- Catalog Number
- 1670520 FDA UDI
- Primary DI / UDI-DI
- 08800069202795 EUDAMEDFDA UDI
- Basic UDI-DI
- 880926429PP38 EUDAMED
- Direct Marketing DI
- 08800069202795 EUDAMED
- FDA Product Code
- EKN FDA UDI
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
- GMDN Term
- Endodontic paper point FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3830 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
PlanBDental® minikut® Paper 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 | 880926429PP38 | 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 95ad2115-b44a-4945-97a1-e96524daf3cd 61 fields · synced Jun 18, 2026
- FDA UDI 4a84a3fb-5bf4-4860-adb6-94dcec200625 35 fields · synced May 30, 2026