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Hand instrument K-file TEKF1021

by Tulsa Dental Products LLC

Hand instrument K-file TEKF1021 is a Class I device made by Tulsa Dental Products LLC, listed in FDA GUDID since 16 Aug 2022 (UDI-DI D716TEKF10211), 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 NumberD716TEKF10211 UDI-DI Date16 Aug 2022ListedStatusListed 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  • Withdrawn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
Hand instrument K-file
Generic name
Manual endodontic file/rasp, reusable
Model / Ref / Catalog
TEKF1021
Primary DI / UDI-DI
D716TEKF10211
FDA product code
EKS
GMDN term
Manual 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: Manual endodontic file/rasp, reusable

Other devices from Tulsa Dental Products LLC

See all devices from Tulsa Dental Products LLC →

Properties

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