FDA 510(k) Application Details - K191133

Device Classification Name	More FDA Info for this Device
510(K) Number	K191133
Device Name	KATANA Cleaner, KATANA Cleaner (Trial)
Applicant	Kuraray Noritake Dental Inc. Ote Center Bldg. 7F Chiyoda-ku 100-0004 JP Other 510(k) Applications for this Company
Contact	Yasujiro Ohara Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PME Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/29/2019
Decision Date	10/08/2019
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