FDA 510(k)

Smart Moves Complete

K-Number: K172765 · 2018-06-01

Decision Date2018-06-01

Product CodeNXC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Smart Moves Complete 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 2018-06-01 under 510(k) number K172765. 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 Smart Moves Complete?

Smart Moves Complete is a medical device that received FDA 510(k) clearance on 2018-06-01. The listed applicant is Great Lakes Orthodontics, Ltd.. The 510(k) number is K172765.

When did Smart Moves Complete receive FDA 510(k) clearance?

Smart Moves Complete received FDA 510(k) clearance on 2018-06-01, under 510(k) number K172765.

Who is the listed applicant for Smart Moves Complete?

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 Smart Moves Complete?

The FDA product code for Smart Moves Complete is NXC.

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.

K150702Exceed Tx

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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.