QuickSleeper 5— 510(k) K243427

Substantially Equivalent

Dentalhitec

FDA 510(k) clearance K243427 for QuickSleeper 5, Substantially Equivalent on 2025-08-01. Applicant: Dentalhitec.

Clearance details

Applicant: Dentalhitec
Product code: Code EGM
Advisory panel: Dental
Date received: 2024-11-05
Decision date: 2025-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mazieres En Mauges, FR

Download summary PDF View on FDA.gov ↗

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