# K170822: Electronic Caries Detector

- Pathway: 510(k) (Traditional)
- Applicant: Ortek Therapeutics, Inc.
- Decided: Sep 11, 2017 after 175 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: 7 generations back to K921979 (1993). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090598: Cariescan Pro, Cariescan, Ltd. (2009) Summary page 5.
- K982105: Oral Potential Meter (Opm), Pertec of Wisconsin, Inc. (1998) Summary page 5.

## Indications for use
The Electronic Caries Detector is for use by dental professionals as an aid in the diagnosis and monitoring of dental caries.

Source page: https://510kreport.com/device/K170822
Methodology: https://510kreport.com/methodology