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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K262980
Device Name INNI-CERA (BCM-W500, BCM-W1000)
Applicant
DentMedi Co., Ltd.
A-Dong 2201, 17, Gosan-Ro 148beon-Gil
Gunposi,  KR 15850
Applicant Contact Jeogin Ha
Correspondent
E & M
230 Simin-Daero, Dongan-Gu
Anyangsi,  KR 14067
Correspondent Contact Sanghwa Myung
Regulation Number872.6660
Classification Product Code
EIH  
Date Received08/27/2026
Decision Date 10/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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