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Hydroxyline Kit - TC

by Taub Products

Hydroxyline Kit - TC (05-1500) is a Class II device made by Taub Products, listed in FDA GUDID since 26 Oct 2016 (UDI-DI D8370515000), 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 NumberD8370515000 UDI-DI Date26 Oct 2016ListedStatusListed 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  • Withdrawn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
Hydroxyline
Generic name
Dental cavity varnish
Model / Ref / Catalog
Kit - TC, 05-1500
Primary DI / UDI-DI
D8370515000
FDA product code
EJK
GMDN term
Dental cavity varnish
Device class
Class II
Regulation number
872.3250
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 6 Milliliter

Similar devices

Other devices filed under FDA product code EJK (Liner, Cavity, Calcium Hydroxide).

Other devices from Taub Products

See all devices from Taub Products →

Properties

  • Single use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)