# K111423: CS 1600 Intraoral Camera

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health, Inc.
- Decided: Mar 2, 2012 after 284 days
- Product code: NBL (Light-Induced Fluorescence Caries Detector )
- Device class: 2
- Regulation: 21 CFR 872.1745
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN990002 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091186: Kodak 1500 Intraoral Camera, Carestream Health, Inc. (2009) Summary page 2.
- K040063: Inspektor Pro, Inspektor Dental Care BV (2004) Summary page 2.
- K092583: Soprolife, Sopro (2010) Summary page 2.

## Indications for use
The CS 1600 is indicated for use by health professionals as an aid in the detection of dental caries. It is also indicated for use in viewing and capturing intraoral or extraoral color video images for the purpose of: * Allowing practitioners to view and magnify all regions of the oral cavity * Assisting in communication with the patient by providing a view of treatment areas before and after a procedure * Providing images for documentation in patient records.

Source page: https://510kreport.com/device/K111423
Methodology: https://510kreport.com/methodology