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Procodile® Paper Points
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PPPR05.000.040Ref PPPR05.000.035Ref PPPR04.000.050Ref PPPR06.000.030Ref PPPR06.000.020Ref PPPR04.000.045
Identity
- Trade Name
- Procodile® Paper Points EUDAMEDProcodile FDA UDI
- Generic Name
- Endodontic paper point FDA UDI
- Device Name
- Sterile Absorbent Paper Points EUDAMEDAbsorbent Paper Points Taper .05, Size 40, 100/PK, mm marked, SB, 40.05 FDA UDI
- Model / Reference
- PPPR05.000.040 EUDAMEDFDA UDIPPPR05.000.035 EUDAMEDPPPR04.000.050 EUDAMEDPPPR06.000.030 EUDAMEDPPPR06.000.020 EUDAMEDPPPR04.000.045 EUDAMED
- Description
- Absorbent Paper Points Taper .05, Size 40, 100/PK, mm marked, SB, 40.05 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809264297766 EUDAMEDFDA UDI08800069203860 EUDAMED08800069203891 EUDAMED08800069203853 EUDAMED08800069203839 EUDAMED08800069203877 EUDAMED08800069203884 EUDAMED
- Basic UDI-DI
- 880926429PP38 EUDAMED
- Direct Marketing DI
- 08809264297766 EUDAMED08800069203860 EUDAMED08800069203891 EUDAMED08800069203853 EUDAMED08800069203839 EUDAMED08800069203877 EUDAMED08800069203884 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
- Germany 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
Procodile® 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 (8)
- EUDAMED 73038435-182b-450f-9a2f-28d0e37aad10 61 fields · synced Jul 29, 2026
- EUDAMED 5cb3ea7f-6965-4734-92b0-2427b8499950 61 fields · synced May 16, 2026
- EUDAMED 771edbb7-6c93-47ec-a863-d9ad6a1433d9 61 fields · synced May 17, 2026
- EUDAMED 4338ca89-3002-4812-8f0f-e1d097352935 61 fields · synced May 17, 2026
- EUDAMED 80927288-21dd-4b21-a59a-9cbe176b0f40 61 fields · synced May 18, 2026
- EUDAMED a1cb944b-5fdb-45ff-a60e-3d086b2ce87d 61 fields · synced May 19, 2026
- EUDAMED 0e9379d1-bee6-48f9-9f80-855156da4e0a 61 fields · synced May 19, 2026
- FDA UDI cd6e0d2a-567a-4fc1-8e14-28e64bf28997 34 fields · synced May 30, 2026