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SmileSet Premium Whitening Refill – 4 Pack 150-0122

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 Number00850078989154 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  • Withdrawn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 Refill – 4 Pack
Generic Name
Dental bleaching agent
Model / Reference
150-0122
Primary DI / UDI-DI
00850078989154
FDA Product Code
MAU
GMDN Term
Dental bleaching agent
Device Class
Class I
Regulation Number
872.6855
GUDID distribution status
In Commercial Distribution

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Properties

  • Single Use
  • Over-the-Counter
  • Premarket Exempt

Other properties (11)

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