Cleared Special

General Cutting Contra Handpiece

K202960 · Nakanishi, Inc. · Dental
Oct 2020
Decision
27d
Days
Class 1
Risk

About This 510(k) Submission

K202960 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, JP). The FDA issued a Cleared decision on October 27, 2020, 27 days after receiving the submission on September 30, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K202960 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2020
Decision Date October 27, 2020
Days to Decision 27 days
Submission Type Special
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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