FX Contra

Handpiece, Contra- And Right-angle Attachment, Dental

Nakanishi INC.

The following data is part of a premarket notification filed by Nakanishi Inc. with the FDA for Fx Contra.

Pre-market Notification Details

Device IDK222518
510k NumberK222518
Device Name:FX Contra
ClassificationHandpiece, Contra- And Right-angle Attachment, Dental
Applicant Nakanishi INC. 700 Shimohinata Kanuma,  JP 322-8666
ContactMasaaki Kikuchi
CorrespondentYulia Nikova
Ken Block Consulting LLC 800 E Campbell Road, Suite 202 Richardson,  TX  75081
Product CodeEGS  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-19
Decision Date2022-11-17

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