Cleared Traditional

The NightBlocks Appliance

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

About This 510(k) Submission

K192581 is an FDA 510(k) clearance for the The NightBlocks Appliance, a Device, Jaw Repositioning (Class II — Special Controls, product code LQZ), submitted by Advanced Facialdontics, LLC (St James, US). The FDA issued a Cleared decision on January 28, 2020, 131 days after receiving the submission on September 19, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.5570.

Submission Details

510(k) Number K192581 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code LQZ — Device, Jaw Repositioning
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.5570