Cleared Traditional

K192767 - Clear Aligner

K192767 is the FDA 510(k) clearance for Clear Aligner by Royal Dental Lab. It is a Class 2 Dental device (product code NXC) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K192767 · Royal Dental Lab · Dental device
Download Printable Device Report (PDF)
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Jan 2020
Decision
100d
Days
Class 2
Risk

K192767 is an FDA 510(k) clearance for the Clear Aligner. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Royal Dental Lab (Shenzhen, CN). The FDA issued a Cleared decision on January 8, 2020 after a review of 100 days - within the typical 510(k) review window.

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 Royal Dental Lab devices

Submission Details

510(k) Number K192767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2019
Decision Date January 08, 2020
Days to Decision 100 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
27d faster than avg
Panel avg: 127d · This submission: 100d
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
Becky Chen

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 126
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K192767.
ULab Systems Dental Aligner Kit
K192596 · Ulab Systems, Inc. · Feb 2020
Argen Clear Aligner, Argen Clear Aligner Premium
K192846 · Argen Corporation · Feb 2020
UniSmile Clear Aligner System
K191837 · Vitang Technology, LLC · Jan 2020
Clear-Aligners
K191823 · Cdb Corporation · Dec 2019
DenMat Orthodontic Aligners
K192470 · Denmat Holdings, LLC · Dec 2019
Krystal Klear Aligners
K182388 · Shatkin F.I.R.S.T., LLC · Dec 2019