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FDA 510(k)

QuickSleeper 5

K-Number: K243427 · 2025-08-01

ApplicantDentalhitec
Decision Date2025-08-01
Product CodeEGM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

QuickSleeper 5 is a medical device manufactured by Dentalhitec. It received FDA 510(k) clearance on 2025-08-01 under approval number K243427. The device is classified under product code EGM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QuickSleeper 5?

QuickSleeper 5 is a medical device that received FDA 510(k) clearance on 2025-08-01. It is manufactured by Dentalhitec. The 510(k) number is K243427.

When was QuickSleeper 5 approved by the FDA?

QuickSleeper 5 received FDA 510(k) clearance on 2025-08-01, under approval number K243427.

What company makes QuickSleeper 5?

QuickSleeper 5 is manufactured by Dentalhitec.

What is the FDA product code for QuickSleeper 5?

The FDA product code for QuickSleeper 5 is EGM.

Official Source

View on FDA Database →

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

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