FDA 510(k) Application Details - K213147

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K213147
Device Name	Powder, Porcelain
Applicant	Kuraray Noritake Dental Inc. Tokiwabashi Tower, 2-6-4, Otemachi Chiyoda-ku 100-0004 JP Other 510(k) Applications for this Company
Contact	Yasujiro Ohara Other 510(k) Applications for this Contact
Regulation Number	872.6660   More FDA Info for this Regulation Number
Classification Product Code	EIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2021
Decision Date	03/28/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review