Skip to content

Premium Plus 904T-BK-100

by Premium Plus (Dongguan) Limited

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD125904TBK1002 UDI-DI Date20 May 2026ListedStatusListed 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  • Withdrawn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
904T-BK-100
Primary DI / UDI-DI
D125904TBK1002
FDA Product Code
KXR
GMDN Term
Dental material application tool, single-use
Device Class
Class I
Regulation Number
872.3140
GUDID distribution status
In Commercial Distribution

Other devices from Premium Plus (Dongguan) Limited

See all devices from Premium Plus (Dongguan) Limited →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No