# K031868: Prophypearls

- Pathway: 510(k) (Special)
- Applicant: Kavo America
- Decided: Jul 9, 2003 after 22 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K973876 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973876: Prophyflex 2, Model 2012, Kavo America (1997) Summary page 1.

## Indications for use
PROPHYpearls is a powder intended for use in removing plaque deposits and stains from teeth by projecting a mixture of water, air, and calcium carbonate onto tooth surfaces.

Source page: https://510kreport.com/device/K031868
Methodology: https://510kreport.com/methodology