Cleared Traditional

Clear Aligners (K210373) - FDA 510(k) Clearance

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

K210373 · Shenzhen Yinuo Dental Technology Co.Ltd · Dental device
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Aug 2021
Decision
200d
Days
Class 2
Risk

K210373 is an FDA 510(k) clearance for the Clear Aligners. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Shenzhen Yinuo Dental Technology Co.Ltd (Shenzhen, CN). The FDA issued a Cleared decision on August 27, 2021 after a review of 200 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 Shenzhen Yinuo Dental Technology Co.Ltd devices

Submission Details

510(k) Number K210373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2021
Decision Date August 27, 2021
Days to Decision 200 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
73d slower than avg
Panel avg: 127d · This submission: 200d
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

Feiying Drug & Medical Consulting Technical Service Group
Gamma Zhang

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 K210373.
Inman Digital Clear Aligners
K210763 · Inman Orthodontic Laboratories, Inc. · Sep 2021
Smylio Invisible Clear Aligners
K212660 · Smylio, Inc. · Sep 2021
SMILERS
K212961 · Biotech Dental Smilers, Sas · Sep 2021
ClearCorrect System
K210320 · Clearcorrect, LLC · Aug 2021
TRIOCLEAR System
K193622 · Perfection Aligner System Hong Kong Limited · Jul 2021
HIT Clear Aligner
K210613 · Cdb Corporation · Jun 2021