Skip to content

Hygitech Hy-139

by Hygitech

Hygitech Hy-139 is a Class I device made by Hygitech, listed in FDA GUDID since 24 Nov 2020 (UDI-DI 03615140002431), 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 Number03615140002431 UDI-DI Date24 Nov 2020ListedStatusListed 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  • Withdrawn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
Hygitech
Generic name
Denture repair kit, professional
Model / Ref / Catalog
HY-139
Primary DI / UDI-DI
03615140002431
FDA product code
FXP
GMDN term
Denture repair kit, professional
Device class
Class I
Regulation number
878.4040
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code FXP (Cover, Shoe, Operating-Room).

Other devices from Hygitech

See all devices from Hygitech →

Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)