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FDA 510(k)

ClearPath Aligner

K-Number: K162609 · 2017-07-06

ApplicantClearpath Orthodontics, Ltd.
Decision Date2017-07-06
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ClearPath Aligner is a medical device manufactured by Clearpath Orthodontics, Ltd.. It received FDA 510(k) clearance on 2017-07-06 under approval number K162609. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClearPath Aligner?

ClearPath Aligner is a medical device that received FDA 510(k) clearance on 2017-07-06. It is manufactured by Clearpath Orthodontics, Ltd.. The 510(k) number is K162609.

When was ClearPath Aligner approved by the FDA?

ClearPath Aligner received FDA 510(k) clearance on 2017-07-06, under approval number K162609.

What company makes ClearPath Aligner?

ClearPath Aligner is manufactured by Clearpath Orthodontics, Ltd..

What is the FDA product code for ClearPath Aligner?

The FDA product code for ClearPath Aligner is NXC.

Other Devices by Clearpath Orthodontics, Ltd.

K202857ClearPath Aligner

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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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