510(k) Report

FDA product code · Dental

Crown And Bridge, Temporary, Resin

EBGClass II21 CFR 872.3770510(k) required189 decisions since 19774 recalls

189 FDA decisions since 1977. 510(k) reviews decided 2021–2025 took a median of 144 days (half between 62 and 187). 4 recalls name this code, 0 of them Class I. The most-cited predicate is K101710, 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 EBG 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 · EBG

4in 2025

2007: 32008: 92009: 22010: 52011: 102012: 52013: 22014: 32015: 62016: 42017: 22018: 42019: 62020: 142021: 32022: 32023: 22024: 52025: 42026 (partial year): 2
2007high 14 (2020) · low 2 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBG

106in 2025

2007: 64 days median2008: 83 days median2010: 103 days median2011: 96 days median2012: 90 days median2014: 114 days median2015: 209 days median2016: 163 days median2018: 202 days median2019: 98 days median2020: 194 days median2021: 265 days median2022: 73 days median2024: 144 days median2025: 106 days median
2007high 265 (2021) · low 64 (2007)2026

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

Recalls per year · EBG

1in 2020

2009: 12020: 1
2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · EBG

1in 2025

2007: 42008: 42009: 12010: 12011: 12012: 52013: 112014: 232015: 262016: 82017: 42019: 62020: 22021: 42022: 22025: 1
2007high 26 (2015) · low 0 (2018)2025

MAUDE reports naming product code EBG, 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
200736404
200898304
20092—11
2010510301
2011109601
201259005
20132—011
20143114023
20156209026
2016416308
20172—04
2018420200
201969806
20201419412
2021326504
202237302
20232—00
2024514400
2025410601
20262—0—
FIG. 1 — EBG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in EBG? 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 872.3770.