FDA · official record K233308Substantially Equivalent

Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)

Name: Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) — FDA K233308
Creator: Nakanishi, Inc.
Keywords: Air Motor (Model name: FX204 M4); Air Motor (Model name: M205), Air Motor (Model name: FX204 M4); Air Motor (Model name: M205), K233308, EFB, FDA

United StatesEFBNakanishi, Inc.

Verified

Official record identity

FDA application number: K233308
Decision date: April 25, 2024
Published decision: Substantially Equivalent

Classification

Product code: EFB

Published parties

Applicant: Nakanishi, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2023-09-29
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.4200

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.