510(k) · Cleared

Cleared

Prophy-Mate

K032395510(k) TraditionalCleared Oct 17, 200374-day reviewClass I21 CFR 872.4200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nakanishi, Inc. · EFB Handpiece, Air-Powered, Dental

Cleared on Oct 17, 2003 after a 74-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided: Oct 17, 2003
Review: 74 days
Class: Class I
Product code: EFB
Recalls: None
Predicates: 0

2 later devices descend from it, 2 citing it directly.

This deviceK032395 Prophy-MateNakanishi, Inc. · 2003
Descendant · cites it directly · 0 of its ownK112673 Prophy-Mate NeoNakanishi, Inc. · 2012
Descendant · cites it directly · 0 of its ownK112869 Easyprophy Series Air Polish Devices, Models Easyprophy 200 and…Beyes Dental Canada, Inc. · 2011

Most influential descendants

Showing 2 of 2 · See all

K112673Prophy-Mate NeoNakanishi, Inc. · 2012 · cites it directly0descendants
K112869Easyprophy Series Air Polish Devices, Models Easyprophy 200 and Easyprophy 400Beyes Dental Canada, Inc. · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K032395	Prophy-Mate	Nakanishi, Inc.	2003	—
+1	K112673	Prophy-Mate Neo	Nakanishi, Inc.	2012	—
+1	K112869	Easyprophy Series Air Polish Devices, Models Easyprophy 200 and Easyprophy 400	Beyes Dental Canada, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	1	0

FIG. 1 — Lineage of K032395, 2003–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EFB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new EFB device

#1 K262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED…score 13.3 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K112673	Prophy-Mate Neo	Nakanishi, Inc.	2012	0
K112869	Easyprophy Series Air Polish Devices, Models Easyprophy 200 and Easyprophy 400	Beyes Dental Canada, Inc.	2011	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K112673 (Nakanishi, Inc., 2012) has gone furthest, with 0 descendants of its own.

How does its category compare?

All EFB devices

EFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EFB

1in 2025

2007high 12 (2007) · low 1 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EFB

209in 2024

2007high 430 (2022) · low 61 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EFB

No recall names EFB since 2007.

Adverse event reports per year · EFB

83in 2025

2007high 157 (2022) · low 13 (2007)2025

MAUDE reports naming product code EFB, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	12	61	13
2008	7	97	19
2009	11	120	40
2010	8	116	78
2011	4	168	96
2012	8	130	97
2013	3	207	61
2014	7	200	73
2015	7	296	87
2016	3	205	122
2017	7	246	153
2018	3	210	81
2019	3	348	117
2020	5	259	94
2021	2	—	123
2022	5	430	157
2023	4	158	116
2024	5	209	104
2025	1	—	83
2026	4	252	—

What is it indicated for?

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.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K032395 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032395: Prophy-Mate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032395

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026