FDA 510(k) Application Details - K203712

Device Classification Name	Device, Jaw Repositioning   More FDA Info for this Device
510(K) Number	K203712
Device Name	Device, Jaw Repositioning
Applicant	Biotex, Inc. 114 Holmes Rd. Houston, TX 77045 US Other 510(k) Applications for this Company
Contact	Wade Munsch Other 510(k) Applications for this Contact
Regulation Number	872.5570   More FDA Info for this Regulation Number
Classification Product Code	LQZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2020
Decision Date	07/20/2021
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