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FDA 510(k)

Exceed Tx

K-Number: K150702 · 2016-03-24

ApplicantGreat Lakes Orthodontics, Ltd.
Decision Date2016-03-24
Product CodeDYW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Exceed Tx is a medical device manufactured by Great Lakes Orthodontics, Ltd.. It received FDA 510(k) clearance on 2016-03-24 under approval number K150702. The device is classified under product code DYW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Exceed Tx?

Exceed Tx is a medical device that received FDA 510(k) clearance on 2016-03-24. It is manufactured by Great Lakes Orthodontics, Ltd.. The 510(k) number is K150702.

When was Exceed Tx approved by the FDA?

Exceed Tx received FDA 510(k) clearance on 2016-03-24, under approval number K150702.

What company makes Exceed Tx?

Exceed Tx is manufactured by Great Lakes Orthodontics, Ltd..

What is the FDA product code for Exceed Tx?

The FDA product code for Exceed Tx is DYW.

Other Devices by Great Lakes Orthodontics, Ltd.

K172765Smart Moves Complete

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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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