# K012070: Orallite Comprehensive Exam Tray

- Pathway: 510(k) (Traditional)
- Applicant: Trylon Corp.
- Decided: Nov 27, 2001 after 148 days
- Product code: MPU (Source, Chemiluminescent Light)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K033033: Vizilite-Blue Oral Exam Kit (2004), 9 descendants of its own
- K082603: Trimira Ocs 3000 (2008), 8 descendants of its own
- K090135: Trimira Identafi 3000 (2009), 7 descendants of its own
- K101140: Dentlight Oral Exam Light Kit (2010), 5 descendants of its own
- K210550: VALO Grand Corded and Accessory Lenses (2021), 3 descendants of its own

## Indications for use
The OralLite Test Kit, when used in combination with conventional visual oral mucosal examination by health care providers, improves identification, evaluation, and monitoring of oral mucosal abnormalities in a patient population at increased risk for oral cancer.

Source page: https://510kreport.com/device/K012070
Methodology: https://510kreport.com/methodology