510(k) Report

FDA product code · Dental

Handpiece, Contra- And Right-Angle Attachment, Dental

EGSClass I21 CFR 872.4200510(k) required73 decisions since 19781 recall

73 FDA decisions since 1978. 510(k) reviews decided 2021–2025 took a median of 151 days (half between 90 and 240). 1 recall names this code; it is not Class I. The most-cited predicate is K011061, named by 10 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 EGS 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 · EGS

2in 2025

2007: 12009: 12010: 22011: 32012: 32013: 12014: 22015: 32017: 22018: 12019: 32020: 12021: 12022: 42023: 12024: 12025: 2
2007high 4 (2022) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EGS

189in 2022

2011: 104 days median2012: 288 days median2015: 245 days median2019: 276 days median2022: 189 days median
2007high 288 (2012) · low 104 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EGS

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EGS

82in 2025

2007: 22008: 142009: 452010: 742011: 22012: 32013: 22014: 382015: 1662016: 2992017: 3162018: 2302019: 2192020: 1912021: 2942022: 2792023: 1152024: 812025: 82
2007high 316 (2017) · low 2 (2007)2025

MAUDE reports naming product code EGS, 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
20071—02
20080—014
20091—045
20102—074
2011310402
2012328803
20131—02
20142—038
201532450166
20160—0299
20172—0316
20181—0230
201932760219
20201—0191
20211—0294
202241890279
20231—1115
20241—081
20252—082
20260—0—
FIG. 1 — EGS by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in EGS? 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 872.4200.