FDA cleared the INNI-CERA (BCM-W500, BCM-W1000) from DentMedi Co., Ltd. on Oct 21, 2026 under K262980, a traditional 510(k). The device falls under product code EIH, Powder, Porcelain, regulated at 21 CFR 872.6660 as a Class 2 device. The review panel was Dental.
FDA logged the submission as received on Aug 27, 2026. The decision came 55 days later, inside the 90 FDA-day goal for a 510(k).
This is the only decision on file for DentMedi Co., Ltd. in the last 12 months of the tracker.
K262980 is the FDA 510(k) for INNI-CERA (BCM-W500, BCM-W1000), submitted by DentMedi Co., Ltd.. FDA's decision date was Oct 21, 2026, under product code EIH (Powder, Porcelain).
DentMedi Co., Ltd., based in Gunposi, is the applicant of record for K262980.
FDA received the submission on Aug 27, 2026 and issued its decision on Oct 21, 2026, 55 days later.
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