# K973200: Caries Stain

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: Nov 6, 1997 after 72 days
- Product code: LFC (Device, Caries Detection)
- Device class: 2
- Regulation: 21 CFR 872.1740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Kar-D-Tek: named in the summary without a submission number
- (no number) Caries Detector: named in the summary without a submission number
- (no number) SEEK: named in the summary without a submission number
- (no number) Caries Finder: named in the summary without a submission number
- (no number) Team Caries Indicator: named in the summary without a submission number
- (no number) Pulpdent Snoop: named in the summary without a submission number

## Indications for use
For use as a color-indicator of caries demineralized dentin. The water-soluble dye differentiates between dentin infected by caries and unaffected dentin and serves as a guide for the dentist-user in the conservative preparation of teeth that require restoration.

Source page: https://510kreport.com/device/K973200
Methodology: https://510kreport.com/methodology