510(k) Report

FDA product code · Dental

Joint, Temporomandibular, Implant

LZDClass III21 CFR 872.3940PMA required3 decisions since 199916 recalls

3 FDA decisions since 1999. 16 recalls name this code, 1 of them Class I.

Call for PMAs to be filed by 3/30/99 per 63 FR 71746 on 12/30/98 - Indicated for reconstruction of the temporomandibular joint.

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 LZD 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 · LZD

1in 2025

2009: 22010: 22012: 52014: 32015: 12017: 12019: 12020: 22021: 12022: 12023: 12024: 22025: 12026 (partial year): 2
2007high 5 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZD

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

Recalls per year · LZD

1in 2025

2014: 142025: 1, 1 Class I2026 (partial year): 1
2007high 14 (2014) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · LZD

226in 2025

2007: 222008: 222009: 322010: 492011: 692012: 732013: 1042014: 962015: 1462016: 1312017: 952018: 2102019: 2042020: 2552021: 2072022: 1932023: 2362024: 2072025: 226
2007high 255 (2020) · low 22 (2007)2025

MAUDE reports naming product code LZD, 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—022
20080—022
20092—032
20102—049
20110—069
20125—073
20130—0104
20143—1496
20151—0146
20160—0131
20171—095
20180—0210
20191—0204
20202—0255
20211—0207
20221—0193
20231—0236
20242—0207
20251—1 (1)226
20262—1—
FIG. 1 — LZD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LZD? 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