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SmileSet Premium Whitening Kit – Black 150-0119

by Ortho Dental Lab, LLC

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 Number00850078989123 UDI-DI Date25 Sep 2025ListedStatusListed 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  • Withdrawn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
SmileSet Premium Whitening Kit – Black
Generic Name
Teeth whitening kit
Model / Reference
150-0119
Primary DI / UDI-DI
00850078989123
FDA Product Code
MAU, EEG
GMDN Term
Teeth whitening kit
Device Class
Class I
Regulation Number
872.6855, 872.6475
GUDID distribution status
In Commercial Distribution

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Properties

  • Over-the-Counter
  • Convenience Kit
  • Premarket Exempt

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No