FDA 510(k) Application Details - K201104

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K201104
Device Name	Aligner, Sequential
Applicant	Aso International Manila, Inc. Atlantica Bldg. 5, Block 12, Phase 1, South Avenue, Cavite Economic Zone Cavite 4106 PH Other 510(k) Applications for this Company
Contact	Hiromichi Takahashi 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	04/24/2020
Decision Date	02/26/2021
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