The NightBlocks Appliance— 510(k) K192581

Name: FDA 510(k) clearance K192581
Creator: U.S. Food and Drug Administration
Published: 2020-01-28

Substantially Equivalent

Advanced Facialdontics, LLC

FDA 510(k) clearance K192581 for The NightBlocks Appliance, Substantially Equivalent on 2020-01-28. Applicant: Advanced Facialdontics, LLC. Device class: 2.

Clearance details

Applicant: Advanced Facialdontics, LLC
Product code: Code LQZ
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2019-09-19
Decision date: 2020-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St James, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.