# K032395: Prophy-Mate

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Oct 17, 2003 after 74 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K112673: Prophy-Mate Neo (2012), 0 descendants of its own
- K112869: Easyprophy Series Air Polish Devices, Models Easyprophy 200 and Easyprophy 400 (2011), 0 descendants of its own

## Indications for use
The Prophy-Mate device is intended for use in dental applications to remove stains and plaque deposits from the teeth by shooting a mixture of sodium bicarbonate powers, air, and water onto tooth surfaces. This product should not be used on patients who are restricted of salt intake (hypernatremia, toxemia of pregnancy); or with critical ulcers in digestive organs, dyshepatia, cardia1 or lung dysfunction, damage or abnormality in a mouth, congestion, bleeding or inflammation in a mouth, contact lenses, or allergies; or who tend to have inflammation or soreness in their oral mucous membrane.

Source page: https://510kreport.com/device/K032395
Methodology: https://510kreport.com/methodology