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AdDent Bio/Screen

by Addent, Inc.

AdDent Bio/Screen (110090) is a Class II device made by Addent, Inc., listed in FDA GUDID since 1 Jun 2017 (UDI-DI D86911009002), 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 NumberD86911009002 UDI-DI Date1 Jun 2017ListedStatusListed 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  • Withdrawn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
AdDent
Generic name
Oral lesion examination light
Model / Ref / Catalog
Bio/Screen, 110090
Primary DI / UDI-DI
D86911009002
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).

Other devices from Addent, Inc.

  • AdDent Compex HD

    Class I
  • AdDent OraBlu

    Class II
  • AdDent Microlux

    Class II
  • AdDent Calset

    Class I

See all devices from Addent, Inc. →

Properties

  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)