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PhytoLight PL1.0

by PhotoDynamic Incorporated

Listed FDA GUDID listing, not in commercial distribution

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00628634327043 UDI-DI Date19 Dec 2022ListedStatusListed GUDID: not 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  • Withdrawn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
PhytoLight
Generic Name
Tooth-bleaching acceleration unit
Model / Ref / Catalog
PL1.0
Primary DI / UDI-DI
00628634327043
FDA Product Code
EEG
GMDN Term
Tooth-bleaching acceleration unit
Device Class
Class I
Regulation Number
872.6475
GUDID distribution status
Not in Commercial Distribution

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