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FDA 510(k)

General Cutting Contra Handpiece

K-Number: K202960 · 2020-10-27

ApplicantNakanishi, Inc.
Decision Date2020-10-27
Product CodeEGS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

General Cutting Contra Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Nakanishi, Inc.. It received FDA 510(k) clearance on 2020-10-27 under 510(k) number K202960. The device is classified under product code EGS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the General Cutting Contra Handpiece?

General Cutting Contra Handpiece is a medical device that received FDA 510(k) clearance on 2020-10-27. The listed applicant is Nakanishi, Inc.. The 510(k) number is K202960.

When did General Cutting Contra Handpiece receive FDA 510(k) clearance?

General Cutting Contra Handpiece received FDA 510(k) clearance on 2020-10-27, under 510(k) number K202960.

Who is the listed applicant for General Cutting Contra Handpiece?

The FDA 510(k) record lists Nakanishi, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for General Cutting Contra Handpiece?

The FDA product code for General Cutting Contra Handpiece is EGS.

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Related Devices (Code: EGS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251869Disposable Prophy Angle (3399-60, 3399-090, 3399-105)Premium Plus (Dongguan) LimitedK240950Disposable Prophy AnglePacific Care LimitedK240183Star E900 Handpiece SeriesDentalez, Inc., Stardental DivisionK230106General Cutting StraightNakanishi, Inc.K222518FX ContraNakanishi, Inc.K220874Smooth Drive contra angle and straight handpiecesLares Research

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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