Identity
- Trade Name
- Absorbent Paper Points EUDAMEDSure-endo FDA UDI
- Generic Name
- Endodontic paper point FDA UDI
- Device Name
- Sterile Absorbent Paper Points EUDAMEDAbsorbent Paper Points Taper .04, Size 70, 100/PK FDA UDI
- Model / Reference
- P910 70.04 EUDAMED20007004 FDA UDI
- Description
- Absorbent Paper Points Taper .04, Size 70, 100/PK FDA UDI
Identifiers
- Catalog Number
- P910 70.04 FDA UDI
- Primary DI / UDI-DI
- 08809264294345 EUDAMEDFDA UDI
- Basic UDI-DI
- 880926429PP38 EUDAMED
- Direct Marketing DI
- 08809264294345 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
No
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
Absorbent 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 53cc4c8a-a9b2-4674-87a1-33c32c5d7b61 61 fields · synced Jul 19, 2026
- FDA UDI 768b2c8f-cfec-4042-9052-3b5feb21c5c3 34 fields · synced May 30, 2026