Cleared Traditional

FX Contra

K222518 · Nakanishi, Inc. · Dental
Nov 2022
Decision
90d
Days
Class 1
Risk

About This 510(k) Submission

K222518 is an FDA 510(k) clearance for the FX Contra, 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 November 17, 2022, 90 days after receiving the submission on August 19, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K222518 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2022
Decision Date November 17, 2022
Days to Decision 90 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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