FDA 510(k) Application Details - K201563

Device Classification Name	Crown And Bridge, Temporary, Resin   More FDA Info for this Device
510(K) Number	K201563
Device Name	Crown And Bridge, Temporary, Resin
Applicant	Quest Dental USA Corp. 17865 Sky Park Circle, Suite L1 Irvine, CA 92614 US Other 510(k) Applications for this Company
Contact	Hirotaka Mori Other 510(k) Applications for this Contact
Regulation Number	872.3770   More FDA Info for this Regulation Number
Classification Product Code	EBG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/10/2020
Decision Date	04/09/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
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