FDA 510(k) Application Details - K223141

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K223141
Device Name	Aligner, Sequential
Applicant	STR8 Oral Care 217 E Cherry Ave Jonesboro, AR 72401 US Other 510(k) Applications for this Company
Contact	Misee Harris 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	10/04/2022
Decision Date	04/24/2023
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