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Hyflex HGPF8311501

by Coltene/Whaledent Inc.

Hyflex HGPF8311501 is a Class I device made by Coltene/Whaledent Inc., listed in FDA GUDID since 26 Feb 2019 (UDI-DI D661HGPF83115011), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD661HGPF83115011 UDI-DI Date26 Feb 2019ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Hyflex
Generic name
Rotary/reciprocating endodontic file/rasp, reusable
Model / reference
HGPF8311501
Primary DI / UDI-DI
D661HGPF83115011
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

Related devices

Category: Rotary/reciprocating endodontic file/rasp, reusable

Other devices from Coltene/Whaledent Inc.

See all devices from Coltene/Whaledent Inc. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (10, all answered No)