Cleared Traditional

K243654 - DentalJect (FDA 510(k) Clearance)

K243654 · Vapocoolshot, Inc. · Dental device
May 2025
Decision
185d
Days
-
Risk

K243654 is an FDA 510(k) clearance for the DentalJect. This device is classified as a Vapocoolant Device.

Submitted by Vapocoolshot, Inc. (Boca Raton, US). The FDA issued a Cleared decision on May 30, 2025, 185 days after receiving the submission on November 26, 2024.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K243654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2024
Decision Date May 30, 2025
Days to Decision 185 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code MLY - Vapocoolant Device
Device Class -