FDA product code · Dental

Solution, Cement Dissolving

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

KZPClass II21 CFR 872.3750510(k) required2 decisions since 19780 recalls

2 FDA decisions since 1978. No recall names this code.

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 KZP 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 · KZP

FDA has decided no KZP device since 2007.

Median 510(k) review, days · KZP

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

Recalls per year · KZP

No recall names KZP since 2007.

Adverse event reports per year · KZP

No MAUDE report names KZP since 2007.

View these four charts as a table

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

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

Planning a device in KZP? 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

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Other codes under 21 CFR 872.3750.

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Solution, Cement Dissolving

What has FDA decided in KZP lately?

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