INNI-CERA (BCM-W500, BCM-W1000)— 510(k) K262980

Name: FDA 510(k) clearance K262980
Creator: U.S. Food and Drug Administration
Published: 2026-10-21

Substantially Equivalent

DentMedi Co., Ltd.

FDA 510(k) clearance K262980 for INNI-CERA (BCM-W500, BCM-W1000), Substantially Equivalent on 2026-10-21. Applicant: DentMedi Co., Ltd.. Device class: 2.

Clearance details

Applicant: DentMedi Co., Ltd.
Product code: Product code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2026-08-27
Decision date: 2026-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gunposi, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.