FDA 510(k) Application Details - K201036

Device Classification Name	More FDA Info for this Device
510(K) Number	K201036
Device Name	PlaniMax Orthodontic Software
Applicant	Choice Biotech Inc. Rm. C, 4F, No.13, Nanke 3rd Rd., Xinshi Dist. Tainan City 74147 TW Other 510(k) Applications for this Company
Contact	Tyler Kuo Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/2020
Decision Date	12/22/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review