Identity
- Trade Name
- Sendoline FDA UDI
- Generic Name
- Manual endodontic file/rasp, single-use FDA UDI
- Model / Reference
- K-File 10 sterile - 25mm, 6pcs FDA UDI
Identifiers
- Catalog Number
- 3525410BS FDA UDI
- Primary DI / UDI-DI
- 17310230019827 FDA UDI
- FDA Product Code
- EKS FDA UDI
- GMDN Term
- Manual endodontic file/rasp, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
No
FDA UDI
Category: Manual endodontic file/rasp, single-use
Sendoline by Directa AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Manual endodontic file/rasp, single-use.
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- K-REAMERS — TULSA DENTAL PRODUCTS LLC · Class I
- K-Files — TULSA DENTAL PRODUCTS LLC · 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
- Directa AB
Sources (1)
- FDA UDI e7d824e6-762c-4289-9c8f-611e41565fdc 33 fields · synced Jun 8, 2026