FDA 510(k)

Exceed Tx

K-Number: K150702 · 2016-03-24

Decision Date2016-03-24

Product CodeDYW

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Exceed Tx is the device name listed in this FDA 510(k) record. The listed applicant is Great Lakes Orthodontics, Ltd.. It received FDA 510(k) clearance on 2016-03-24 under 510(k) 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. The listed applicant is Great Lakes Orthodontics, Ltd.. The 510(k) number is K150702.

When did Exceed Tx receive FDA 510(k) clearance?

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

Who is the listed applicant for Exceed Tx?

The FDA 510(k) record lists Great Lakes Orthodontics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Exceed Tx?

The FDA product code for Exceed Tx is DYW.

Other records listing Great Lakes Orthodontics, Ltd. 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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.