Cleared Traditional

General Cutting Contra Handpiece

K182999 · Nakanishi, Inc. · Dental
Apr 2019
Decision
168d
Days
Class 1
Risk

About This 510(k) Submission

K182999 is an FDA 510(k) clearance for the General Cutting Contra Handpiece, a Handpiece, Contra- And Right-angle Attachment, Dental (Class I — General Controls, product code EGS), submitted by Nakanishi, Inc. (Kanuma-Shi, JP). The FDA issued a Cleared decision on April 16, 2019, 168 days after receiving the submission on October 30, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K182999 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2018
Decision Date April 16, 2019
Days to Decision 168 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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