Identity
- Trade Name
- Endodontic Hand Instruments FDA UDI
- Generic Name
- Rotary/reciprocating endodontic file/rasp, reusable FDA UDI
- Device Name
- Ready•Steel K-FILE 030 25MM FDA UDI
- Model / Reference
- 6843025 FDA UDI
- Description
- Ready•Steel K-FILE 030 25MM FDA UDI
Identifiers
- Catalog Number
- 6843025 FDA UDI
- Primary DI / UDI-DI
- D71668430251 FDA UDI
- FDA Product Code
- EKS FDA UDI
- GMDN Term
- Rotary/reciprocating endodontic file/rasp, reusable 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
No
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: Rotary/reciprocating endodontic file/rasp, reusable
Endodontic Hand Instruments by Tulsa Dental Products Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rotary/reciprocating endodontic file/rasp, reusable.
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- X-Factor™ Minimally Invasive NiTi Files 20/.03 (21mm) — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. · 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
- Tulsa Dental Products Llc
Sources (1)
- FDA UDI 90ad2f90-0770-49fe-9f73-a4f3b91bb7e6 34 fields · synced May 31, 2026