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FDA 510(k)

STRONG Dental Handpieces

K-Number: K171436 · 2018-01-05

ApplicantSaeshin Precision Co., Ltd.
Decision Date2018-01-05
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 2018-01-05 under approval number K171436. 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 2018-01-05. It is manufactured by Saeshin Precision Co., Ltd.. The 510(k) number is K171436.

When was STRONG Dental Handpieces approved by the FDA?

STRONG Dental Handpieces received FDA 510(k) clearance on 2018-01-05, under approval number K171436.

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.

K182892TRAUS Dental Handpieces K181129STRONG Dental Handpieces K192561TRAUS SUS20 K201292TRAUS SIP20 K212043TRAUS ENDO K221741TRAUS Air Dental Handpiece

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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. K182892TRAUS Dental HandpiecesSaeshin Precision Co., Ltd. K182999General Cutting Contra HandpieceNakanishi, Inc. K181129STRONG Dental HandpiecesSaeshin Precision Co., Ltd. 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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