# K112673: Prophy-Mate Neo

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Feb 7, 2012 after 146 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: 3 generations back to K900709 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032395: Prophy-Mate, Nakanishi, Inc. (2003) Summary page 1.
- K973876: Prophyflex 2, Model 2012, Kavo America (1997) Summary page 1.
- K022119: Ems Air-Flow Handy 2 Dental Handpiece, Electro Medical Systems SA (2002) Summary page 1.

## Indications for use
The Prophy-Mate Nec device is intended for use in dental applications to remove stains and plaque depositsfrom the teeth by shooting a mixture of sodium bicarbonatepowders or calcium carbonatepowders, air, and water onto tooth surfaces. The Prophy-Mate neo can also be used in dental applications to prepare surface prior to bonding and to preparefor pit andfissure sealant.

Source page: https://510kreport.com/device/K112673
Methodology: https://510kreport.com/methodology