Identity
- Trade Name
- HyFlex CM FDA UDI
- Generic Name
- Rotary/reciprocating endodontic file/rasp, reusable FDA UDI
- Device Name
- HYFLEX NT FILE ASST LRG 25MM FDA UDI
- Model / Reference
- SBHNT825LRG FDA UDI
- Description
- HYFLEX NT FILE ASST LRG 25MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661SBHNT825LRG1 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
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: Rotary/reciprocating endodontic file/rasp, reusable
HyFlex CM by Coltene/Whaledent Inc. — 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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- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
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- DIA-X FILE — DiaDent Group International · Class I
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- X-Factor™ Minimally Invasive NiTi Files Assorted .02 Taper (25mm) — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. · Class I
- 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
- Coltene/Whaledent Inc.
Sources (1)
- FDA UDI 459ac5b0-1f70-4c25-bc74-cbfcc728f3e9 34 fields · synced Jun 9, 2026