QuickSleeper 5
K-Number: K243427 · 2025-08-01
ApplicantDentalhitec
Decision Date2025-08-01
Product CodeEGM
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
QuickSleeper 5 is the device name listed in this FDA 510(k) record. The listed applicant is Dentalhitec. It received FDA 510(k) clearance on 2025-08-01 under 510(k) 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. The listed applicant is Dentalhitec. The 510(k) number is K243427.
When did QuickSleeper 5 receive FDA 510(k) clearance?
QuickSleeper 5 received FDA 510(k) clearance on 2025-08-01, under 510(k) number K243427.
Who is the listed applicant for QuickSleeper 5?
The FDA 510(k) record lists Dentalhitec as the applicant. This does not by itself establish the device manufacturer.
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.