FDA 510(k)

The NightBlocks Appliance

K-Number: K192581 · 2020-01-28

Decision Date2020-01-28

Product CodeLQZ

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

The NightBlocks Appliance is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Facialdontics, LLC. It received FDA 510(k) clearance on 2020-01-28 under 510(k) number K192581. The device is classified under product code LQZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The NightBlocks Appliance?

The NightBlocks Appliance is a medical device that received FDA 510(k) clearance on 2020-01-28. The listed applicant is Advanced Facialdontics, LLC. The 510(k) number is K192581.

When did The NightBlocks Appliance receive FDA 510(k) clearance?

The NightBlocks Appliance received FDA 510(k) clearance on 2020-01-28, under 510(k) number K192581.

Who is the listed applicant for The NightBlocks Appliance?

The FDA 510(k) record lists Advanced Facialdontics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The NightBlocks Appliance?

The FDA product code for The NightBlocks Appliance is LQZ.

Other records listing Advanced Facialdontics, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182820The POD

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.