Exceed Tx— 510(k) K150702

Substantially Equivalent

Great Lakes Orthodontics, Ltd.

FDA 510(k) clearance K150702 for Exceed Tx, Substantially Equivalent on 2016-03-24. Applicant: Great Lakes Orthodontics, Ltd.. Device class: 2.

Clearance details

Applicant: Great Lakes Orthodontics, Ltd.
Product code: Code DYW
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2015-03-18
Decision date: 2016-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tonawanda, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.