FDA 510(k) Application Details - K233754

Device Classification Name	Device, Jaw Repositioning   More FDA Info for this Device
510(K) Number	K233754
Device Name	Device, Jaw Repositioning
Applicant	Aiomega, LLC 3187 Paluxy Drive Tyler, TX 75701 US Other 510(k) Applications for this Company
Contact	Raghavendra Ghuge 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	11/22/2023
Decision Date	02/23/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review