FDA 510(k) Application Details - K222323

Device Classification Name	More FDA Info for this Device
510(K) Number	K222323
Device Name	Black Diamond
Applicant	Elevate Oral Care, LLC 346 Pike Rd, Suite 5 West Palm Beach, FL 33411 US Other 510(k) Applications for this Company
Contact	Steve Pardue Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/02/2022
Decision Date	06/23/2023
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