510(k) Report

FDA product code · Dental

Material, Dressing, Surgical, Polylactic Acid

LPGClass IIIPMA required2 decisions since 19830 recalls

2 FDA decisions since 1983. 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 LPG 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 · LPG

2in 2025

2007: 52008: 12009: 22010: 22012: 32013: 82014: 112015: 62016: 62017: 42018: 62019: 82020: 12021: 62022: 32023: 42024: 32025: 22026 (partial year): 3
2007high 11 (2014) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPG

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

Recalls per year · LPG

No recall names LPG since 2007.

Adverse event reports per year · LPG

1in 2025

2009: 22011: 52013: 52014: 22018: 22020: 12021: 12023: 22024: 12025: 1
2007high 5 (2011) · low 0 (2007)2025

MAUDE reports naming product code LPG, 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
20075—00
20081—00
20092—02
20102—00
20110—05
20123—00
20138—05
201411—02
20156—00
20166—00
20174—00
20186—02
20198—00
20201—01
20216—01
20223—00
20234—02
20243—01
20252—01
20263—0—
FIG. 1 — LPG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LPG? 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