Cleared Traditional

Krystal Klear Aligners (K182388) - FDA 510(k) Clearance

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

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 143
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K182388.
Smylio Aligners
K260788 · Smylio, Inc. · May 2026
SureSmile Aligner (ASSY500020)
K260722 · Dentsply Sirona, Inc. · Apr 2026
ZSmile System
K253282 · Dror Orthodesign , Ltd. · Feb 2026
Clear Aligner (SCF-3348)
K251454 · Beame Medical Technology (Shenzhen) Limited · Jan 2026
Primeprint Direct Aligner
K250739 · Dreve Dentamid GmbH · Nov 2025
Invisalign® Palatal Expander System
K252931 · Align Technology, Inc. · Oct 2025