Cleared Traditional

QuickAligners (K211537) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211537 · Oral Image, Inc. · Dental device
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Oct 2021
Decision
161d
Days
Class 2
Risk

K211537 is an FDA 510(k) clearance for the QuickAligners. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Oral Image, Inc. (San Diego, US). The FDA issued a Cleared decision on October 26, 2021 after a review of 161 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 Oral Image, Inc. devices

Submission Details

510(k) Number K211537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2021
Decision Date October 26, 2021
Days to Decision 161 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
34d slower than avg
Panel avg: 127d · This submission: 161d
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 Consultant

Aclivi, LLC
Chris Brown

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NXC Aligner, Sequential

All 123
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K211537.
Redline
K213297 · Johns Dental Laboratories · Feb 2022
Precision Align
K212772 · Precision Align, LLC · Jan 2022
Ortho Aligner System
K212496 · Ortho Lab Services, LLC · Nov 2021
Clear Aligner
K203688 · Wuxi EA Medical Instruments Technologies Limited. · Oct 2021
Inman Digital Clear Aligners
K210763 · Inman Orthodontic Laboratories, Inc. · Sep 2021
Smylio Invisible Clear Aligners
K212660 · Smylio, Inc. · Sep 2021