Cleared Traditional

Titanium Turbine

K230888 · Nakanishi, Inc. · Dental
Jun 2023
Decision
63d
Days
Class 1
Risk

About This 510(k) Submission

K230888 is an FDA 510(k) clearance for the Titanium 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 2, 2023, 63 days after receiving the submission on March 31, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K230888 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2023
Decision Date June 02, 2023
Days to Decision 63 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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