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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 a medical device manufactured by Young Dental Manufacturing Co. 1, LLC. It received FDA 510(k) clearance on 2018-08-20 under approval 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. It is manufactured by Young Dental Manufacturing Co. 1, LLC. The 510(k) number is K171377.

When was Young INFINITY Cordless Handpiece System approved by the FDA?

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

What company makes Young INFINITY Cordless Handpiece System?

Young INFINITY Cordless Handpiece System is manufactured by Young Dental Manufacturing Co. 1, LLC.

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

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

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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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