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FDA 510(k)

STRONG Dental Handpieces

K-Number: K181129 · 2019-01-31

ApplicantSaeshin Precision Co., Ltd.
Decision Date2019-01-31
Product CodeEGS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STRONG Dental Handpieces is the device name listed in this FDA 510(k) record. The listed applicant is Saeshin Precision Co., Ltd.. It received FDA 510(k) clearance on 2019-01-31 under 510(k) number K181129. 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 STRONG Dental Handpieces?

STRONG Dental Handpieces is a medical device that received FDA 510(k) clearance on 2019-01-31. The listed applicant is Saeshin Precision Co., Ltd.. The 510(k) number is K181129.

When did STRONG Dental Handpieces receive FDA 510(k) clearance?

STRONG Dental Handpieces received FDA 510(k) clearance on 2019-01-31, under 510(k) number K181129.

Who is the listed applicant for STRONG Dental Handpieces?

The FDA 510(k) record lists Saeshin Precision Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRONG Dental Handpieces?

The FDA product code for STRONG Dental Handpieces is EGS.

Other records listing Saeshin Precision Co., Ltd. as applicant

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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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