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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
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