FDA product code · Dental

Adhesive, Denture, Karaya With Sodium Borate

Name: FDA decisions, review times, recalls and adverse event reports for product code KOR
Creator: 510(k) Report

KORClass III21 CFR 872.3400PMA required0 decisions0 recalls

0 FDA decisions. 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 KOR 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 · KOR

FDA has decided no KOR device since 2007.

Median 510(k) review, days · KOR

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

Recalls per year · KOR

No recall names KOR since 2007.

Adverse event reports per year · KOR

1in 2024

2007high 1 (2024) · low 0 (2007)2025

MAUDE reports naming product code KOR, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	1
2025	—	0
2026	—	—

FIG. 1 — KOR by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KOR? 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

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