Cleared Special

K202960 - General Cutting Contra Handpiece

K202960 is an FDA 510(k) clearance for General Cutting Contra Handpiece, manufactured by Nakanishi, Inc.. The device is a Class 1 Dental device with product code EGS cleared through the Special 510(k) pathway after a 27-day FDA review.

K202960 · Nakanishi, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
27d
Days
Class 1
Risk

K202960 is an FDA 510(k) clearance for the General Cutting Contra Handpiece. 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 October 27, 2020 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K202960

510(k) Number K202960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 128d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

EGS Device Classification - Class 1, General Controls

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 71
Devices cleared under the same product code (EGS) and FDA review panel - the closest regulatory comparables to K202960.
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K213139 · Kavo Dental GmbH · Dec 2021
TRAUS Dental Handpieces
K182892 · Saeshin Precision Co., Ltd. · Nov 2019
General Cutting Contra Handpiece
K182999 · Nakanishi, Inc. · Apr 2019
STRONG Dental Handpieces
K181129 · Saeshin Precision Co., Ltd. · Jan 2019
K202960 · General Cutting Contra Handpiece
Download PDF FDA Summary Nakanishi, Inc.