Skip to content

HyFlex EDM 60041085

by Coltène/Whaledent AG

HyFlex EDM 60041085 is a Class I device made by Coltène/Whaledent AG, listed in FDA GUDID since 22 Oct 2025 (UDI-DI 14260614073613), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number14260614073613 UDI-DI Date22 Oct 2025ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
HyFlex EDM
Generic name
Rotary/reciprocating endodontic file/rasp, reusable
Model / Ref / Catalog
60041085
Primary DI / UDI-DI
14260614073613
FDA product code
EKS
GMDN term
Rotary/reciprocating endodontic file/rasp, reusable
Device class
Class I
Regulation number
872.4565
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Coltène/Whaledent AG

See all devices from Coltène/Whaledent AG →

Properties

  • Supplied sterile
  • Sterilise before use
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)