FDA 510(k) Application Details - K213175

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K213175
Device Name	Material, Impression
Applicant	No Stress Impress LLC 2012 Scrimshaw PL Wilmington, NC 28405 US Other 510(k) Applications for this Company
Contact	Misael Otero Other 510(k) Applications for this Contact
Regulation Number	872.3660   More FDA Info for this Regulation Number
Classification Product Code	ELW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2021
Decision Date	01/19/2023
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