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SmileDirectClub Whitening Pen - 4 Pack Plus Light 150-0142

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 Number00860012825530 UDI-DI Date16 Oct 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  • Withdrawn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
SmileDirectClub Whitening Pen - 4 Pack Plus Light
Generic Name
Teeth whitening kit
Model / Reference
150-0142
Primary DI / UDI-DI
00860012825530
FDA Product Code
EEG, MAU
GMDN Term
Teeth whitening kit
Device Class
Class I
Regulation Number
872.6475, 872.6855
GUDID distribution status
In Commercial Distribution

Other devices from Ortho Dental Lab, LLC

See all devices from Ortho Dental Lab, LLC →

Properties

  • Over-the-Counter
  • Premarket Exempt

Other properties (12)

  • Sterile: No
  • Single Use: 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