FDA 510(k) Application Details - K233768

Device Classification Name	Varnish, Cavity   More FDA Info for this Device
510(K) Number	K233768
Device Name	Varnish, Cavity
Applicant	Elevate Oral Care 346 Pike Rd Suite 5 West Palm Beach, FL 33411 US Other 510(k) Applications for this Company
Contact	Steven Pardue Other 510(k) Applications for this Contact
Regulation Number	872.3260   More FDA Info for this Regulation Number
Classification Product Code	LBH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/24/2023
Decision Date	07/18/2024
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