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510(k) K243427

QuickSleeper 5 by Dentalhitec — Product Code EGM

K243427 is an FDA 510(k) premarket notification submitted by Dentalhitec for the device "QuickSleeper 5". The FDA issued a decision of Substantially Equivalent on August 1, 2025. The device falls under product code EGM (Injector, Jet, Mechanical-Powered), a Class II device regulated under 21 CFR 872.4475.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2025
Date Received
November 5, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector, Jet, Mechanical-Powered
Device Class
Class II
Regulation Number
872.4475
Review Panel
DE
Submission Type

Other clearances for product code EGM

  • K083811 — W&H HANDPIECE ANESTO, MODEL: RA-5 (January 14, 2010)
  • K964802 — CYBERJET LOCAL ANESTHESIA SYSTEM (May 27, 1997)
  • K962017 — HYPODERMIC JET INJECTION APPARATUS (July 26, 1996)
  • K904279 — PAROJECT ANESTHETIC SYRINGE (December 7, 1990)
  • K864294 — HENKE-JECT PRESSURE SYRINGE (MODIFICATION) (November 4, 1987)
  • K864732 — GRADTECH SYRINGE SYSTEM (April 15, 1987)
  • K864861 — INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM (February 13, 1987)
  • K834361 — JSB JET SYRINGE (March 5, 1984)
  • K821273 — MAYO SCISSOR STRAIGHT 6 3/4 (May 28, 1982)
  • K790193 — MIZZY SYRIJET MARK IV (April 23, 1979)

FDA data resources