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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 a medical device manufactured by Saeshin Precision Co., Ltd.. It received FDA 510(k) clearance on 2019-01-31 under approval 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. It is manufactured by Saeshin Precision Co., Ltd.. The 510(k) number is K181129.

When was STRONG Dental Handpieces approved by the FDA?

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

What company makes STRONG Dental Handpieces?

STRONG Dental Handpieces is manufactured by Saeshin Precision Co., Ltd..

What is the FDA product code for STRONG Dental Handpieces?

The FDA product code for STRONG Dental Handpieces is EGS.

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Other Devices by Saeshin Precision Co., Ltd.

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Related Devices (Code: EGS)

K162856Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)Bonart Co., Ltd. K162397Titan 3 Low Speed Angle AttachmentsDentalez, Inc. K171436STRONG Dental HandpiecesSaeshin Precision Co., Ltd. K182892TRAUS Dental HandpiecesSaeshin Precision Co., Ltd. K182999General Cutting Contra HandpieceNakanishi, Inc. K202960General Cutting Contra HandpieceNakanishi, Inc.

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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