# K101140: Dentlight Oral Exam Light Kit

- Pathway: 510(k) (Traditional)
- Applicant: Dentlight, Inc.
- Decided: Jul 15, 2010 after 84 days
- Product code: NXV (Diagnostic Light, Soft Tissue Detector)
- Device class: 2
- Regulation: 21 CFR 872.6350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K003995 (2001). 9 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070523: Modification to: Velscope, Led Dental, Inc. (2007) Summary page 1.
- K073483: Sapphire O/E Oral Examination System, Den-Mat Holdings, LLC (2008) Summary page 1.
- K090135: Trimira Identafi 3000, Remicalm, LLC (2009) Summary page 1.

## Most influential descendants
- K210550: VALO Grand Corded and Accessory Lenses (2021), 3 descendants of its own
- K220471: VALO X, VALO X Accessory Lenses (2022), 2 descendants of its own
- K253461: Demi Pro (2025), 0 descendants of its own
- K243921: LED Curing Lights (DB686 HALO) (2025), 0 descendants of its own
- K123169: Oralid (2013), 0 descendants of its own

## Indications for use
Dentlight Oral Exam Light Kit is indicated to be used by a dentist and physician for illumination to aid visualization during oral procedures and as an adjunct to enhance the visualization for oral examination of mucosal abnormalities and oral lesions.

Source page: https://510kreport.com/device/K101140
Methodology: https://510kreport.com/methodology