K201799 is the FDA 510(k) clearance record for CleaniCal, a class II device, cleared for Maruchi on 2021-02-12 under FDA product code EJK (Liner, Cavity, Calcium Hydroxide). FDA records list 8 510(k) clearances for Maruchi, from 2012-03-19 to 2023-02-14 . As of 2026-09-10 , FDA records show no recalls naming K201799.
Clearance record Decision date 2021-02-12 Received 2020-06-30 (227 days to decision) Product code EJK Liner, Cavity, Calcium HydroxideRegulation 21 CFR 872.3250 Device class Class II Review panel Dental Applicant Maruchi 2-208, Medical Industry Complex Bldg., 42-10, Taejanggongdan, Wonju-Si, KR 510(k) summary Summary PDF ↗ Third party review No
Clearances, product code EJK Trailing 12 months 2 clearances under product code EJK in the twelve months to October 2026, January 2026 the highest month at 1. Show the numbers FIRST ARTICLE / WEEKLY
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About this record Sourced from the FDA 510(k) premarket notification database, ingested from openFDA. MDM adds the decision time in days, the product code cross-link, recalls sharing that product code, and MDM coverage of the record.
Predicate devices are not listed. The openFDA 510(k) endpoint does not publish predicate references, so MDM does not assert them. Where a 510(k) summary exists, the FDA PDF is linked above and names the predicate itself.
Data as of 2026-09-28 , the FDA export date for this dataset. Page last changed 2026-09-05 . View this record on fda.gov ↗ (opens on fda.gov)
