FDA 510(k) Application Details - K191774

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K191774
Device Name	Aligner, Sequential
Applicant	3D Global Biotech Inc. 21F.-1, No.99, Sec. 1, Xintai 5th Rd., Xizhi Dist., New Taipei City 221 TW Other 510(k) Applications for this Company
Contact	Keng-Liang Ou Other 510(k) Applications for this Contact
Regulation Number	872.5470   More FDA Info for this Regulation Number
Classification Product Code	NXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2019
Decision Date	09/30/2019
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