Cleared Traditional

K190394 - SunClear Aligner system

K190394 is the FDA 510(k) clearance for SunClear Aligner system by Sun Dental Laboratories, LLC. It is a Class 2 Dental device (product code NXC) cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K190394 · Sun Dental Laboratories, LLC · Dental device
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Dec 2019
Decision
300d
Days
Class 2
Risk

K190394 is an FDA 510(k) clearance for the SunClear Aligner system. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Sun Dental Laboratories, LLC (St. Petersburg, US). The FDA issued a Cleared decision on December 16, 2019 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

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 Sun Dental Laboratories, LLC devices

Submission Details

510(k) Number K190394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2019
Decision Date December 16, 2019
Days to Decision 300 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
173d slower than avg
Panel avg: 127d · This submission: 300d
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

Sun Dental Laboratories, LLC / Promedic, LLC
Paul Dryden

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 K190394.
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
Vivid Aligners
K190003 · Orthodent Laboratory, Inc. · Nov 2019
SmileAlign Orthodontic Aligner System
K191774 · 3D Global Biotech, Inc. · Sep 2019
3M Clarity Aligners
K192119 · 3M Company · Sep 2019