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ViziLite® 650118

by Den-Mat Holdings, LLC

ViziLite® 650118 is a Class II device made by Den-Mat Holdings, LLC, listed in FDA GUDID since 22 Sep 2022 (UDI-DI D8136501180), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD8136501180 UDI-DI Date22 Sep 2022ListedStatusListed 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  • Withdrawn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
ViziLite®
Generic name
Oral lesion examination light
Model / Ref / Catalog
650118
Primary DI / UDI-DI
D8136501180
FDA product code
NXV
GMDN term
Oral lesion examination light
Device class
Class II
Regulation number
872.6350
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code NXV (Diagnostic Light, Soft Tissue Detector).

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Properties

  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)