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Hedstrom-Files 07321090R

by Tulsa Dental Products LLC

Hedstrom-Files 07321090R is a Class I device made by Tulsa Dental Products LLC, listed in FDA GUDID since 21 Oct 2022 (UDI-DI D7160730210901), 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 NumberD7160730210901 UDI-DI Date21 Oct 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  • Withdrawn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
Hedstrom-Files
Generic name
Manual endodontic file/rasp, single-use
Model / Ref / Catalog
07321090R
Primary DI / UDI-DI
D7160730210901
FDA product code
EKS
GMDN term
Manual endodontic file/rasp, single-use
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, single-use

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
Other properties (11, all answered No)