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Premium Plus 7501-Y

by Premium Plus International Limited

Premium Plus 7501-Y is a Class I device made by Premium Plus International Limited, listed in FDA GUDID since 7 Jan 2020 (UDI-DI D8387501Y2), 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 NumberD8387501Y2 UDI-DI Date7 Jan 2020ListedStatusListed 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  • Withdrawn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
Premium Plus
Generic name
Dental material application tool, single-use
Model / reference
7501-Y
Primary DI / UDI-DI
D8387501Y2
FDA product code
EJB
GMDN term
Dental material application tool, single-use
Device class
Class I
Regulation number
872.4565
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental material application tool, single-use

Other devices from Premium Plus International Limited

See all devices from Premium Plus International Limited →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)