FDA product code · Dental

Prophy Powder, Airbrush Accessory

Name: FDA decisions, review times, recalls and adverse event reports for product code PIP
Creator: 510(k) Report

PIPClass II21 CFR 872.6080510(k) required2 decisions since 20140 recalls

2 FDA decisions since 2014. No recall names this code. The most-cited predicate is K140684, named by 1 later device.

An air polishing powder to be used with an airbrush for prophylaxis in the oral cavity.

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

FIG. A — Illustration, dental panel

Twenty years of PIP at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · PIP

1in 2016

2007high 1 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PIP

Too few PIP 510(k)s in any year since 2007 to give a median.

Recalls per year · PIP

No recall names PIP since 2007.

Adverse event reports per year · PIP

No MAUDE report names PIP since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	1	—	0
2015	0	—	0
2016	1	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

FIG. 1 — PIP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PIP? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 872.6080.

KOJ Airbrush

Prophy Powder, Airbrush Accessory

Which predicates do PIP devices cite most?

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What has FDA decided in PIP lately?

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