QuickSleeper 5— 510(k) K243427

Substantially Equivalent

Dentalhitec

FDA 510(k) clearance K243427 for QuickSleeper 5, Substantially Equivalent on 2025-08-01. Applicant: Dentalhitec. Device class: 2.

Clearance details

Applicant: Dentalhitec
Product code: Code EGM
Device class: Class 2
Regulation: 21 CFR 872.4475
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 ↗

Recent devices under product code EGM

K083811 — W&H HANDPIECE ANESTO, MODEL: RA-52010-01-14
K964802 — CYBERJET LOCAL ANESTHESIA SYSTEM1997-05-27
K962017 — HYPODERMIC JET INJECTION APPARATUS1996-07-26
K904279 — PAROJECT ANESTHETIC SYRINGE1990-12-07
K864294 — HENKE-JECT PRESSURE SYRINGE (MODIFICATION)1987-11-04

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