Cleared Traditional

K192581 - The NightBlocks Appliance

K192581 is an FDA 510(k) clearance for The NightBlocks Appliance, manufactured by Advanced Facialdontics, LLC. The device is a Class 2 Dental device with product code LQZ cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K192581 · Advanced Facialdontics, LLC · Dental device
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Jan 2020
Decision
131d
Days
Class 2
Risk

K192581 is an FDA 510(k) clearance for the The NightBlocks Appliance. Classified as Device, Jaw Repositioning (product code LQZ), Class II - Special Controls.

Submitted by Advanced Facialdontics, LLC (St James, US). The FDA issued a Cleared decision on January 28, 2020 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - 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 Advanced Facialdontics, LLC devices

FDA 510(k) Submission Details - K192581

510(k) Number K192581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2019
Decision Date January 28, 2020
Days to Decision 131 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
4d slower than avg
Panel avg: 127d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LQZ Device Classification - Class 2, Special Controls

Product Code LQZ Device, Jaw Repositioning
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
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 - LQZ Device, Jaw Repositioning

All 12
Devices cleared under the same product code (LQZ) and FDA review panel - the closest regulatory comparables to K192581.
RADx Intraoral Appliance for Snoring and Sleep Apnea
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The Slide
K203712 · Biotex, Inc. · Jul 2021
Slow Wave DS8
K191320 · Slow Wave, Inc. · Oct 2020
SML-OSA2 Appliances
K162816 · Selane Products, Inc. · Jul 2017
ATG/SM-OSA APPLIANCES
K130130 · Selane Products, Inc. · Aug 2013
MILLENIUM ANTI-SNORING DEVICE
K112627 · Millenium Dental Laboratory, Inc. · Jun 2012