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AdDent Microlux 2

by Addent, Inc.

AdDent Microlux 2 (110080) is a Class II device made by Addent, Inc., cleared under FDA 510(k) K062961 on 8 Feb 2007 and listed in FDA GUDID since 1 Jun 2017 (UDI-DI D86911008001), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K062961

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD86911008001 UDI-DI Date1 Jun 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK062961 Date8 Feb 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K062961 decided 8 Feb 2007 Active
  • FDA GUDID UDI-DI D86911008001 listed 1 Jun 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K062961
  2. Listed FDA GUDID D86911008001

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AdDent
Generic name
Fibreoptic dental light
Model / Ref / Catalog
Microlux 2, 110080
Primary DI / UDI-DI
D86911008001
510(k) Number
FDA product code
NTK
GMDN term
Fibreoptic dental light
Device class
Class II
Regulation number
872.1745
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code NTK (Caries Detector, Laser Light, Transmission).

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)