Cleared Traditional

General Cutting Straight

K230106 · Nakanishi, Inc. · Dental
May 2023
Decision
131d
Days
Class 1
Risk

About This 510(k) Submission

K230106 is an FDA 510(k) clearance for the General Cutting Straight, a Handpiece, Contra- And Right-angle Attachment, Dental (Class I — General Controls, product code EGS), submitted by Nakanishi, Inc. (Kanuma, JP). The FDA issued a Cleared decision on May 24, 2023, 131 days after receiving the submission on January 13, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K230106 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 2023
Decision Date May 24, 2023
Days to Decision 131 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EGS — Handpiece, Contra- And Right-angle Attachment, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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