FDA 510(k) Application Details - K213297

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K213297
Device Name	Aligner, Sequential
Applicant	Johns Dental Laboratories 423 S. 13th ST Terre Haute, IN 47807 US Other 510(k) Applications for this Company
Contact	Marni Buis 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	10/01/2021
Decision Date	02/09/2022
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