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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Orthodontic
510(k) Number K211992
Device Name Ortho MI System
Applicant
Osteonic Co., Ltd.
303ho, 405ho, 505-2ho, 505-3ho, 902ho, 1004ho, 1201ho
1202ho, 1206ho, 38 Digital-Ro 29-Gil
Guro-Gu,  KR 08381
Applicant Contact Lee Jisun
Correspondent
Osteonic Co., Ltd.
303ho, 405ho, 505-2ho, 505-3ho, 902ho, 1004ho, 1201ho
1202ho, 1206ho, 38 Digital-Ro 29-Gil
Guro-Gu,  KR 08381
Correspondent Contact Lee Jisun
Regulation Number872.3640
Classification Product Code
OAT  
Date Received06/28/2021
Decision Date 10/15/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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