510(k) Report

FDA product code · Dental

Device, Jaw Repositioning

LQZClass II21 CFR 872.5570510(k) required27 decisions since 19870 recalls

27 FDA decisions since 1987. 510(k) reviews decided 2021–2025 took a median of 135 days (half between 114 and 173). No recall names this code. The most-cited predicate is K130130, named by 6 later devices.

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 LQZ 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 · LQZ

1in 2024

2009: 22011: 12012: 22013: 12017: 12020: 22021: 12023: 12024: 1
2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LQZ

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

Recalls per year · LQZ

No recall names LQZ since 2007.

Adverse event reports per year · LQZ

2in 2021

2009: 12010: 12012: 22014: 22016: 42017: 12021: 2
2007high 4 (2016) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20092—01
20100—01
20111—00
20122—02
20131—00
20140—02
20150—00
20160—04
20171—01
20180—00
20190—00
20202—00
20211—02
20220—00
20231—00
20241—00
20250—00
20260—0—
FIG. 1 — LQZ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LQZ? 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 872.5570.