Identity
- Trade Name
- HyFlex EDM FDA UDI
- Generic Name
- Rotary/reciprocating endodontic file/rasp, reusable FDA UDI
- Device Name
- HyFlex EDM Shaping Set Simple 25/.12, 10/.05, 25/.~, 25mm FDA UDI
- Model / Reference
- 60019363 FDA UDI
- Description
- HyFlex EDM Shaping Set Simple 25/.12, 10/.05, 25/.~, 25mm FDA UDI
Identifiers
- Catalog Number
- 60019363 FDA UDI
- Primary DI / UDI-DI
- E165600193630 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Moist Heat or Steam Sterilization FDA UDI
Category: Rotary/reciprocating endodontic file/rasp, reusable
HyFlex EDM by Coltène/Whaledent AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rotary/reciprocating endodontic file/rasp, reusable.
- Brasseler USA — Peter Brasseler Holdings, LLC
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY · Class I
- X-Factor™ Minimally Invasive NiTi Files Assorted Sizes 25, 40, 60 (21mm) — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. · Class I
- DIA-X FILE — DiaDent Group International · Class I
- Hyflex — Coltene/Whaledent Inc. · Class I
- ProFile Orifice Opener — TULSA DENTAL PRODUCTS LLC · Class I
- X-Factor™ Minimally Invasive NiTi Files Assorted .02 Taper (25mm) — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Coltène/Whaledent AG
Sources (1)
- FDA UDI 1525d707-a065-4c97-92d9-9750d616f55a 36 fields · synced Jun 7, 2026