# K073483: Sapphire O/E Oral Examination System

- Pathway: 510(k) (Traditional)
- Applicant: Den-Mat Holdings, LLC
- Decided: Apr 3, 2008 after 114 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
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 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
- 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
- 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

## Indications for use
The Sapphire O/E oral examination light is intended for use by a dentist or qualified health-care provider as an adjunct to traditional bral examination by white light to enhance the visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or pre-malignant dysphasia. Sapphire O/E oral examination light is further intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion and thus aid in determining the appropriate margin for surgical excision.

Source page: https://510kreport.com/device/K073483
Methodology: https://510kreport.com/methodology