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EdgeEndo .04 Paper Points
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SPP2004-1Ref SPP3006-1Ref SPP5006-1Ref SPP4006-1Ref SPP2504-1Ref SPP2006-1Ref SPP8004-1Ref SPP06AST-1Ref SPP2506-1Ref SPP1506-1Ref SPP3004-1
Identity
- Trade Name
- EdgeEndo .04 Paper Points EUDAMEDEdgeEndo .06 Paper Points EUDAMEDEdgeEndo® Paper Points EUDAMEDEdge .04 PP FDA UDIEdge .06 PP FDA UDI
- Generic Name
- Endodontic paper point FDA UDI
- Device Name
- Sterile Absorbent Paper Points EUDAMEDEdge 04 Paper Points 30.04 FDA UDIEdge 04 Paper Points 80.04 FDA UDIEdge 06 Paper Points 40.06 FDA UDIEdge 06 Paper Points 25.06 FDA UDIEdge 04 Paper Points 25.04 FDA UDIEdge 06 Paper Points 20.06 FDA UDIEdge 04 Paper Points 20.04 FDA UDIEdge 06 Paper Points 50.06 FDA UDIEdge 06 Paper Points 30.06 FDA UDIEDGE X7 06 PAPER POINTS ASSORTED - (20,25,30,35,40,45) FDA UDIEdge 06 Paper Points 15.06 FDA UDI
- Model / Reference
- SPP2004-1 EUDAMEDFDA UDISPP3006-1 EUDAMEDFDA UDISPP5006-1 EUDAMEDFDA UDISPP4006-1 EUDAMEDFDA UDISPP2504-1 EUDAMEDFDA UDISPP2006-1 EUDAMEDFDA UDISPP8004-1 EUDAMEDFDA UDISPP06AST-1 EUDAMEDFDA UDISPP2506-1 EUDAMEDFDA UDISPP1506-1 EUDAMEDFDA UDISPP3004-1 EUDAMEDFDA UDI
- Description
- Edge 04 Paper Points 30.04 FDA UDIEdge 04 Paper Points 80.04 FDA UDIEdge 06 Paper Points 40.06 FDA UDIEdge 06 Paper Points 25.06 FDA UDIEdge 04 Paper Points 25.04 FDA UDIEdge 06 Paper Points 20.06 FDA UDIEdge 04 Paper Points 20.04 FDA UDIEdge 06 Paper Points 50.06 FDA UDIEdge 06 Paper Points 30.06 FDA UDIEDGE X7 06 PAPER POINTS ASSORTED - (20,25,30,35,40,45) FDA UDIEdge 06 Paper Points 15.06 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800069209503 EUDAMEDFDA UDI08800069209602 EUDAMEDFDA UDI08800069209640 EUDAMEDFDA UDI08800069209626 EUDAMEDFDA UDI08800069209510 EUDAMEDFDA UDI08800069209589 EUDAMEDFDA UDI08800069213173 EUDAMEDFDA UDI08800069209824 EUDAMEDFDA UDI08800069209596 EUDAMEDFDA UDI08800069209572 EUDAMEDFDA UDI08800069209527 EUDAMEDFDA UDI
- Basic UDI-DI
- 880926429PP38 EUDAMED
- Direct Marketing DI
- 08800069209503 EUDAMED08800069209602 EUDAMED08800069209640 EUDAMED08800069209626 EUDAMED08800069209510 EUDAMED08800069209589 EUDAMED08800069213173 EUDAMED08800069209824 EUDAMED08800069209596 EUDAMED08800069209572 EUDAMED08800069209527 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
EdgeEndo .04 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 (32)
- EUDAMED 6d97f9c0-d29a-4223-978e-17d1f44b7f9f 61 fields · synced Aug 4, 2026
- EUDAMED 63496fd1-4bbc-4e07-b3f9-2b830a8dccfb 61 fields · synced May 16, 2026
- EUDAMED f9c7c76b-d425-4d47-bd85-1bf3eaffa3d4 61 fields · synced May 16, 2026
- EUDAMED 91d890f8-4177-4379-906f-79a596d4f997 61 fields · synced May 17, 2026
- EUDAMED f7ce559a-2d18-47f3-96b0-a19f45100d64 61 fields · synced May 17, 2026
- EUDAMED ee35dfbf-f8d7-4402-994f-b0828ec69b40 61 fields · synced May 17, 2026
- EUDAMED 8addba0f-5012-48b4-8a83-1ed6570bc2bf 61 fields · synced May 17, 2026
- EUDAMED c4d7d3a0-c5fe-4f6b-916c-dbb4ab554d1f 61 fields · synced May 18, 2026
- EUDAMED 71bd2fa8-469a-427a-8aab-c6313360ac68 61 fields · synced May 18, 2026
- EUDAMED 22e93d84-d2fa-45ad-841e-0d0c3848a680 61 fields · synced May 18, 2026
- EUDAMED 06160544-f556-4e46-8504-f89faa323a77 61 fields · synced May 18, 2026
- FDA UDI cc0eb0d1-9e45-46d1-a778-948723cc1e50 34 fields · synced May 25, 2026
- FDA UDI f0379b58-8deb-4763-bf97-6a9b7544f967 34 fields · synced May 29, 2026
- FDA UDI 88d803dc-caed-4c42-911a-1fb00134f41d 34 fields · synced May 29, 2026
- FDA UDI 6e819236-b525-45f5-92e4-514b296b5a58 34 fields · synced May 30, 2026
- FDA UDI 44728538-0ed2-4c35-85b1-e4782abcdd11 34 fields · synced May 30, 2026
- FDA UDI 4e1f1f57-bb5a-41c5-927c-7ba591c1e5e6 34 fields · synced May 30, 2026
- FDA UDI c4720006-d9dc-4388-872a-0a7f5ea9383b 34 fields · synced May 30, 2026
- FDA UDI 0ab4b59f-0440-4e0a-8a83-4c14d5c132e9 34 fields · synced May 30, 2026
- FDA UDI 19f5183b-bb6a-4e05-be83-ca6ffbc60e43 34 fields · synced May 30, 2026
- FDA UDI 21d520b4-f1c7-437b-b5dc-3a9385cae685 34 fields · synced May 30, 2026
- FDA UDI 446e6ff5-c757-41a5-808d-74d24b453d9c 34 fields · synced May 30, 2026
- EUDAMED 7b1f4055-017a-4086-a53a-49399f1b0aef 61 fields · synced Jul 9, 2026
- EUDAMED 1a4cd195-bfed-4c07-b491-558418affd74 61 fields · synced Jul 9, 2026
- EUDAMED ff69eb7e-7014-47e0-8a78-18a479a7596b 61 fields · synced Jul 11, 2026
- EUDAMED 3f4d2c3f-f853-4863-b799-eebd8e5ceee5 61 fields · synced Jul 15, 2026
- EUDAMED 22471681-e7f2-4ebd-8834-b63a3c9bcb93 61 fields · synced Jul 20, 2026
- EUDAMED 60f4cfa4-bdb5-4853-a81c-01c8ba5a3e18 61 fields · synced Jul 22, 2026
- EUDAMED 1143b6d8-e5d7-4bc8-95ab-54ad1c5148aa 61 fields · synced Jul 24, 2026
- EUDAMED 3928f3af-263b-4e59-b0fd-7db364284ec0 61 fields · synced Jul 26, 2026
- EUDAMED 77faca2e-0121-47a2-954b-9d48616c24b9 61 fields · synced Jul 27, 2026
- EUDAMED a7fa02e1-632e-42a8-ba39-07cdb63fe21b 61 fields · synced Aug 1, 2026