Cleared Traditional

Stainless Turbine

K203791 · Nakanishi, Inc. · Dental
Jun 2022
Decision
540d
Days
Class 1
Risk

About This 510(k) Submission

K203791 is an FDA 510(k) clearance for the Stainless Turbine, 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 June 21, 2022, 540 days after receiving the submission on December 28, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K203791 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2020
Decision Date June 21, 2022
Days to Decision 540 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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