Cleared Traditional

K182388 - Krystal Klear Aligners

K182388 is the FDA 510(k) clearance for Krystal Klear Aligners by Shatkin F.I.R.S.T., LLC. It is a Class 2 Dental device (product code NXC) cleared through the Traditional 510(k) pathway after a 471-day FDA review.

K182388 · Shatkin F.I.R.S.T., LLC · Dental device
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Dec 2019
Decision
471d
Days
Class 2
Risk

K182388 is an FDA 510(k) clearance for the Krystal Klear Aligners. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Shatkin F.I.R.S.T., LLC (Amherst, US). The FDA issued a Cleared decision on December 19, 2019 after a review of 471 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Shatkin F.I.R.S.T., LLC devices

Submission Details

510(k) Number K182388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2018
Decision Date December 19, 2019
Days to Decision 471 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
344d slower than avg
Panel avg: 127d · This submission: 471d
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 126
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K182388.
Clear Aligner
K192767 · Royal Dental Lab · Jan 2020
Clear-Aligners
K191823 · Cdb Corporation · Dec 2019
DenMat Orthodontic Aligners
K192470 · Denmat Holdings, LLC · Dec 2019
SunClear Aligner system
K190394 · Sun Dental Laboratories, LLC · Dec 2019
Vivid Aligners
K190003 · Orthodent Laboratory, Inc. · Nov 2019
SmileAlign Orthodontic Aligner System
K191774 · 3D Global Biotech, Inc. · Sep 2019