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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 a medical device manufactured by Advanced Facialdontics, LLC. It received FDA 510(k) clearance on 2020-01-28 under approval 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. It is manufactured by Advanced Facialdontics, LLC. The 510(k) number is K192581.

When was The NightBlocks Appliance approved by the FDA?

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

What company makes The NightBlocks Appliance?

The NightBlocks Appliance is manufactured by Advanced Facialdontics, LLC.

What is the FDA product code for The NightBlocks Appliance?

The FDA product code for The NightBlocks Appliance is LQZ.

Other Devices by Advanced Facialdontics, LLC

Related Devices (Code: LQZ)

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.