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Microlux Transilluminator

by Addent, Inc.

510(k) K062961

Microlux Transilluminator is a Class II device made by Addent, Inc., cleared under FDA 510(k) K062961 on 8 Feb 2007, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK062961 Date8 Feb 2007ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
NTK
Device class
Class II
Regulation
21 CFR Part 872.1745
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K062961

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K062961
UDI-DISize and differences
AdDent Microlux
Addent, Inc.
620007 / MicroluxD86962000706 —On the market
AdDent Microlux 2
Addent, Inc.
110080 / Microlux 2D86911008001 —On the market

Similar devices

Other devices filed under FDA product code NTK (Light Transmission Caries 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. →