Cleared Traditional

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

K233308 · Nakanishi, Inc. · Dental
Apr 2024
Decision
209d
Days
Class 1
Risk

About This 510(k) Submission

K233308 is an FDA 510(k) clearance for the Air Motor (Model name: FX204 M4); Air Motor (Model name: M205), a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by Nakanishi, Inc. (Kanuma, JP). The FDA issued a Cleared decision on April 25, 2024, 209 days after receiving the submission on September 29, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K233308 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2023
Decision Date April 25, 2024
Days to Decision 209 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EFB — Handpiece, Air-powered, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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