510(k) Report

FDA product code · Dental

Resin, Root Canal Filling

KIFClass II21 CFR 872.3820510(k) required148 decisions since 19771 recall

148 FDA decisions since 1977. 510(k) reviews decided 2021–2025 took a median of 90 days (half between 59 and 136). 1 recall names this code; it is not Class I. The most-cited predicate is K080917, named by 12 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 KIF 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 · KIF

7in 2025

2007: 22008: 42009: 52010: 52012: 52013: 22014: 102015: 12016: 52017: 32018: 52019: 72020: 32021: 122022: 32023: 72024: 82025: 72026 (partial year): 7
2007high 12 (2021) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KIF

90in 2025

2008: 31 days median2009: 94 days median2010: 75 days median2012: 172 days median2014: 220 days median2016: 212 days median2017: 211 days median2018: 147 days median2019: 252 days median2020: 239 days median2021: 89 days median2022: 152 days median2023: 59 days median2024: 96 days median2025: 90 days median2026 (partial year): 108 days median
2007high 252 (2019) · low 31 (2008)2026

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

Recalls per year · KIF

1in 2009

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

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

Adverse event reports per year · KIF

55in 2025

2008: 22009: 72010: 102011: 82012: 42013: 792014: 4212015: 152016: 52017: 52018: 132019: 62020: 32021: 92022: 102023: 72024: 102025: 55
2007high 421 (2014) · low 0 (2007)2025

MAUDE reports naming product code KIF, 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
20072—00
200843102
200959417
2010575010
20110—08
2012517204
20132—079
2014102200421
20151—015
2016521205
2017321105
20185147013
2019725206
2020323903
2021128909
20223152010
202375907
2024896010
2025790055
202671080—
FIG. 1 — KIF by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KIF? 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 872.3820.