Cleared Traditional

K222518 - FX Contra (FDA 510(k) Clearance)

Class I Dental device.

K222518 · Nakanishi, Inc. · Dental device
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Optimized for regulatory review, auditing and printing
Nov 2022
Decision
90d
Days
Class 1
Risk

K222518 is an FDA 510(k) clearance for the FX Contra. Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Nakanishi, Inc. (Kanuma, JP). The FDA issued a Cleared decision on November 17, 2022 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Nakanishi, Inc. devices

Submission Details

510(k) Number K222518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EGS Handpiece, Contra- And Right-angle Attachment, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Ken Block Consulting, LLC
Yulia Nikova

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EGS Handpiece, Contra- And Right-angle Attachment, Dental

All 72
Devices cleared under the same product code (EGS) and FDA review panel - the closest regulatory comparables to K222518.
Disposable Prophy Angle (3399-60, 3399-090, 3399-105)
K251869 · Premium Plus (Dongguan) Limited · Sep 2025
Disposable Prophy Angle
K240950 · Pacific Care Limited · May 2025
Star E900 Handpiece Series
K240183 · Dentalez, Inc., Stardental Division · Sep 2024
General Cutting Straight
K230106 · Nakanishi, Inc. · May 2023