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GoldenDent GK15

by GoldenDent

GoldenDent GK15 is a Class I device made by GoldenDent, listed in FDA GUDID since 25 Feb 2021 (UDI-DI 00850011211434), 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 Number00850011211434 UDI-DI Date25 Feb 2021ListedStatusListed 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  • Withdrawn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
GoldenDent
Generic name
Manual endodontic file/rasp, reusable
Model / Ref / Catalog
GK15
Primary DI / UDI-DI
00850011211434
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 GoldenDent

See all devices from GoldenDent →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)