FDA 510(k) Application Details - K211345

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K211345
Device Name	Material, Tooth Shade, Resin
Applicant	Perfect Fit Crowns, LLC 1128 Royal Palm Beach Blvd, #166 Royal Palm Beach, FL 33411 US Other 510(k) Applications for this Company
Contact	Steve Ziskind Other 510(k) Applications for this Contact
Regulation Number	872.3690   More FDA Info for this Regulation Number
Classification Product Code	EBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/03/2021
Decision Date	11/24/2021
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