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FDA 510(k) Application Details - K230106
Device Classification Name
Handpiece, Contra- And Right-Angle Attachment, Dental
More FDA Info for this Device
510(K) Number
K230106
Device Name
Handpiece, Contra- And Right-Angle Attachment, Dental
Applicant
Nakanishi Inc.
700 Shimohinata
Kanuma 322-8666 JP
Other 510(k) Applications for this Company
Contact
Masaaki Kikuchi
Other 510(k) Applications for this Contact
Regulation Number
872.4200
More FDA Info for this Regulation Number
Classification Product Code
EGS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/13/2023
Decision Date
05/24/2023
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
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