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Paper Points
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PP04.000.035Ref 25918Ref PP02.000.025Ref PP04.000.020Ref PP04.000.040Ref 25919Ref 25908Ref PP04.000.025Ref 25956Ref PP04.000.030Ref PP02.000.035Ref 25962Ref 25970Ref 25971Ref 25920Ref 25921Ref 25972Ref PP04.000.015Ref PP02.000.S1Ref 25948
Identity
- Trade Name
- Paper Points EUDAMEDPAPER POINT, 4% N°20 FDA UDI
- Generic Name
- Endodontic paper point FDA UDI
- Device Name
- Sterile Absorbent Paper Points EUDAMEDUsed in root canal therapy to remove moisture from the root canal or to introduce medicaments Box of 100 - N°20 (Yellow) FDA UDI
- Model / Reference
- PP04.000.035 EUDAMED25918 EUDAMEDPP02.000.025 EUDAMEDPP04.000.020 EUDAMEDPP04.000.040 EUDAMED25919 EUDAMED25908 EUDAMEDPP04.000.025 EUDAMED25956 EUDAMEDPP04.000.030 EUDAMEDPP02.000.035 EUDAMED25962 EUDAMED25970 EUDAMED25971 EUDAMED25920 EUDAMED25921 EUDAMED25972 EUDAMEDPP04.000.015 EUDAMEDPP02.000.S1 EUDAMED25948 EUDAMEDFDA UDI
- Description
- Used in root canal therapy to remove moisture from the root canal or to introduce medicaments Box of 100 - N°20 (Yellow) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800069204089 EUDAMED08809264298794 EUDAMED08800069204126 EUDAMED08800069204058 EUDAMED08800069204096 EUDAMED08809264298800 EUDAMED08809264298244 EUDAMED08800069204065 EUDAMED08809264298831 EUDAMED08800069204072 EUDAMED08800069204140 EUDAMED08809264298848 EUDAMED08809264298855 EUDAMED08809264298862 EUDAMED08809264298817 EUDAMED08809264298824 EUDAMED08809264298879 EUDAMED08800069204041 EUDAMED08800069204164 EUDAMED08809264298541 EUDAMEDFDA UDI
- Basic UDI-DI
- 880926429PP38 EUDAMED
- Direct Marketing DI
- 08800069204089 EUDAMED08809264298794 EUDAMED08800069204126 EUDAMED08800069204058 EUDAMED08800069204096 EUDAMED08809264298800 EUDAMED08809264298244 EUDAMED08800069204065 EUDAMED08809264298831 EUDAMED08800069204072 EUDAMED08800069204140 EUDAMED08809264298848 EUDAMED08809264298855 EUDAMED08809264298862 EUDAMED08809264298817 EUDAMED08809264298824 EUDAMED08809264298879 EUDAMED08800069204041 EUDAMED08800069204164 EUDAMED08809264298541 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 EUDAMEDFrance 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
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 (21)
- EUDAMED 191cbd4f-c537-4699-a380-a7883ca2ee05 61 fields · synced Sep 18, 2026
- EUDAMED 6a78fccf-26aa-4d3b-bf1f-3a84d8c98520 61 fields · synced May 16, 2026
- EUDAMED 3ebcec79-d1fc-48bb-901a-e41d9cd407d2 61 fields · synced May 16, 2026
- EUDAMED 20cf9b03-c1b3-4386-bc2b-0100322844cc 61 fields · synced May 16, 2026
- EUDAMED f085cecc-8c6d-4094-aae3-5d72a089ce66 61 fields · synced May 16, 2026
- EUDAMED c59cef8d-46c3-47fd-b50f-39822f3b4f7a 61 fields · synced May 17, 2026
- EUDAMED bffe7b4e-79c7-436c-a091-c723a5f8f13f 61 fields · synced May 17, 2026
- EUDAMED 9a878d38-9692-4738-b595-70292b413561 61 fields · synced May 17, 2026
- EUDAMED bc202a7c-703a-4700-8859-b788a624f8be 61 fields · synced May 18, 2026
- EUDAMED 19548a02-7dd2-4f9c-afb8-b2c85d92ad7d 61 fields · synced May 18, 2026
- EUDAMED 71309f45-c9df-4fd3-b72a-b0a0da9a6fb1 61 fields · synced May 18, 2026
- EUDAMED 538f152e-0159-454c-906b-65efbfa91c03 61 fields · synced May 18, 2026
- EUDAMED a3ba43de-6d9c-48be-aff1-279474c2ea33 61 fields · synced May 18, 2026
- EUDAMED 3308ad4b-45b7-43ad-b93b-56df44bd248c 61 fields · synced May 18, 2026
- EUDAMED 1a91a79d-c54e-4089-a657-ddad711a9f67 61 fields · synced May 18, 2026
- EUDAMED a9ff38ab-c7e3-4809-bbfa-7387076824a8 61 fields · synced May 18, 2026
- EUDAMED 1558cbd5-e86f-495a-94b8-0205dc281097 61 fields · synced May 19, 2026
- EUDAMED aa61045c-1035-42a0-b6cc-b1bd90dde9dc 61 fields · synced May 19, 2026
- EUDAMED ff7633ff-7080-4d3a-85ba-dc8f2816609c 61 fields · synced May 19, 2026
- EUDAMED b080c37c-045a-4802-aed8-64a2a05d9489 61 fields · synced May 19, 2026
- FDA UDI 761f9a45-e413-4b54-b410-99a71d690b29 33 fields · synced May 30, 2026