# K041614: Microlux DL

- Pathway: 510(k) (Traditional)
- Applicant: Addent, Inc.
- Decided: Apr 4, 2005 after 293 days
- Product code: EAZ (Light, Operating, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003995 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012070: Orallite Comprehensive Exam Tray, Trylon Corp. (2001) Summary page 1.
- K003995: Speculite/Orallite, Trylon Corp. (2001) Summary page 1.

## Indications for use
This device is used as an aid to improve the visualization of oral lesions. It is designed to be used by a dentist or health care provider, in combination with a traditional examination by incandescent light.

Source page: https://510kreport.com/device/K041614
Methodology: https://510kreport.com/methodology