Identity
- Trade Name
- ProFile 29Series FDA UDI
- Generic Name
- Manual endodontic file/rasp, reusable FDA UDI
- Device Name
- Profile SS S29 04/25mm-Hnd FDA UDI
- Model / Reference
- SF042506 FDA UDI
- Description
- Profile SS S29 04/25mm-Hnd FDA UDI
Identifiers
- Catalog Number
- SF042506 FDA UDI
- Primary DI / UDI-DI
- D716SF0425061 FDA UDI
- FDA Product Code
- EKS FDA UDI
- GMDN Term
- Manual 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Manual endodontic file/rasp, reusable
ProFile 29Series by Tulsa Dental Products Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual endodontic file/rasp, reusable.
- K-Files 21mm 070, pu: 6 pcs — Diaswiss SA · Class I
- REAMERS — DiaDent Group International · Class I
- K-Files — MICRO MEGA · Class I
- Endodontic Files — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class IIa
- KOMET Root Canal Files — Gebr. Brasseler GmbH & Co. KG · Class I
- Endodontic Files — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class IIa
- SafeSiders — ESSENTIAL DENTAL SYSTEMS, INC. · Class I
- Hedstroem 015/31mm — LM-Instruments Oy · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tulsa Dental Products Llc
Sources (1)
- FDA UDI 3a8b0c36-401c-4fda-8cad-a4ddfff09833 34 fields · synced May 30, 2026