Oral Surgery Contra

Handpiece, Rotary Bone Cutting

Nakanishi INC.

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

Pre-market Notification Details

Device IDK211584
510k NumberK211584
Device Name:Oral Surgery Contra
ClassificationHandpiece, Rotary Bone Cutting
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 CodeKMW  
CFR Regulation Number872.4120 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-24
Decision Date2021-08-19

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