FDA 510(k) Application Details - K223912

Device Classification Name	Barrier, Animal Source, Intraoral   More FDA Info for this Device
510(K) Number	K223912
Device Name	Barrier, Animal Source, Intraoral
Applicant	SigmaGraft Inc. 575 Sally Place Fullerton, CA 92831 US Other 510(k) Applications for this Company
Contact	Elcin Chang Other 510(k) Applications for this Contact
Regulation Number	872.3930   More FDA Info for this Regulation Number
Classification Product Code	NPL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/29/2022
Decision Date	08/17/2023
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