Cleared Traditional

K172765 - Smart Moves Complete

K172765 is the FDA 510(k) clearance for Smart Moves Complete by Great Lakes Orthodontics, Ltd.. It is a Class 2 Dental device (product code NXC) cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K172765 · Great Lakes Orthodontics, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
261d
Days
Class 2
Risk

K172765 is an FDA 510(k) clearance for the Smart Moves Complete. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Great Lakes Orthodontics, Ltd. (Tonawanda, US). The FDA issued a Cleared decision on June 1, 2018 after a review of 261 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Great Lakes Orthodontics, Ltd. devices

Submission Details

510(k) Number K172765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2017
Decision Date June 01, 2018
Days to Decision 261 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 127d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NXC Aligner, Sequential
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NXC Aligner, Sequential

All 124
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K172765.
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Blue Sky Bio Aligner
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