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FDA 510(k)

Young INFINITY Cordless Handpiece System

K-Number: K171377 · 2018-08-20

ApplicantYoung Dental Manufacturing Co. 1, LLC
Decision Date2018-08-20
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Young INFINITY Cordless Handpiece System is the device name listed in this FDA 510(k) record. The listed applicant is Young Dental Manufacturing Co. 1, LLC. It received FDA 510(k) clearance on 2018-08-20 under 510(k) number K171377. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Young INFINITY Cordless Handpiece System?

Young INFINITY Cordless Handpiece System is a medical device that received FDA 510(k) clearance on 2018-08-20. The listed applicant is Young Dental Manufacturing Co. 1, LLC. The 510(k) number is K171377.

When did Young INFINITY Cordless Handpiece System receive FDA 510(k) clearance?

Young INFINITY Cordless Handpiece System received FDA 510(k) clearance on 2018-08-20, under 510(k) number K171377.

Who is the listed applicant for Young INFINITY Cordless Handpiece System?

The FDA 510(k) record lists Young Dental Manufacturing Co. 1, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Young INFINITY Cordless Handpiece System?

The FDA product code for Young INFINITY Cordless Handpiece System is EKX.

Other records listing Young Dental Manufacturing Co. 1, LLC as applicant

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.

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Related Devices (Code: EKX)

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.

K252223Alpha Endo Handpiece (Alpha Endo)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K251597InnerView SystemPerimetrics, Inc.K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L.K242514Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)Shenzhen Rogin Medical Co., Ltd.K241065ChecQ (AC100)Dentis Co., Ltd.K243911HPR Cordless Hygiene HandpieceHandpiece Headquarters

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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