510(k) K230888

Device
Titanium Turbine
Applicant
Nakanishi, Inc.
510(k) number
K230888
Product code
EFB
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-02
Date received
2023-03-31
Regulation
872.4200
Classification name
Handpiece, Air-Powered, Dental
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Masaaki Kikuchi
Address
700 Shimohinata Kanuma JP 322-8666 322-8666

FDA Registration Numbers

Source Documents

510(k) summary PDF

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