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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 K211308
Device Name INNI-CERA
Applicant
Aon Co., Ltd
A-Dong 2508,2201, 17, Gosan-ro 148beon-gil
gunpo,  KR 15850
Applicant Contact julie choi
Correspondent
E&M
D-1474, 230, Simin-daero, Dongan-gu
anyang,  KR 14067
Correspondent Contact sanghwa myung
Regulation Number872.6660
Classification Product Code
EIH  
Date Received04/29/2021
Decision Date 10/04/2021
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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