# K241880: Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Sep 20, 2024 after 84 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: 7 generations back to K900709 (1990). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151912: AIR-FLOW handy 3.0 PLUS, E.M.S Electro Medical Systems S.A (2016) Summary page 5.
- K171174: PERIO-FLOW nozzle, E.M.S Electro Medical Systems S.A (2017) Summary page 5.

## Indications for use
Perio-Mate: Perio-Mate is intended for the following application(s): Removal of supragingival/subgingival soft deposits and soft deposits on prostheses (including implant abutments). Perio Mate Nozzle Tip: Perio Mate Nozzle Tip is intended for the following application(s): Removal of subgingival soft deposits and soft deposits on prostheses (including implant abutments). The Perio Mate Nozzle Tip and Perio-Mate is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

Source page: https://510kreport.com/device/K241880
Methodology: https://510kreport.com/methodology