Identity
- Trade Name
- ROEKO Paper Points FDA UDI
- Generic Name
- Endodontic paper point FDA UDI
- Device Name
- ROEKO Paper Points Top color ISO 40 FDA UDI
- Model / Reference
- 344540 FDA UDI
- Description
- ROEKO Paper Points Top color ISO 40 FDA UDI
Identifiers
- Catalog Number
- 344540 FDA UDI
- Primary DI / UDI-DI
- E1653445401 FDA UDI
- FDA Product Code
- EKN FDA UDI
- GMDN Term
- Endodontic paper point FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3830 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Category: Endodontic paper point
ROEKO Paper Points by Coltène/Whaledent AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endodontic paper point.
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- MM MARKED PAPER POINTS — DiaDent Group International · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Coltène/Whaledent AG
Sources (1)
- FDA UDI d7235439-fc21-47df-808d-53b18552fdbf 36 fields · synced May 31, 2026