FDA 510(k) Application Details - K172281

Device Classification Name	Crown And Bridge, Temporary, Resin   More FDA Info for this Device
510(K) Number	K172281
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	07/28/2017
Decision Date	10/19/2017
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