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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthodontic Software
510(k) Number K201036
Device Name PlaniMax Orthodontic Software
Applicant
Choice Biotech, Inc.
Rm. C, 4f, #13, Nanke 3rd Rd., Xinshi Dist.
Tainan City,  TW 74147
Applicant Contact Tyler Kuo
Correspondent
Choice Biotech, Inc.
Rm. C, 4f, #13, Nanke 3rd Rd., Xinshi Dist.
Tainan City,  TW 74147
Correspondent Contact Tyler Kuo
Regulation Number872.5470
Classification Product Code
PNN  
Date Received04/20/2020
Decision Date 12/22/2020
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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