FDA 510(k) Application Details - K192701

Device Classification Name	More FDA Info for this Device
510(K) Number	K192701
Device Name	DIBS (Digital Indirect Bonding System)
Applicant	OrthoSelect, LLC 831 E 340 S Suite 170 American Fork, UT 84003 US Other 510(k) Applications for this Company
Contact	Steven N. Gardner 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	09/27/2019
Decision Date	04/21/2020
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