Cleared Traditional

K243654 - DentalJect (FDA 510(k) Clearance)

K243654 · Vapocoolshot, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
185d
Days
-
Risk

K243654 is an FDA 510(k) clearance for the DentalJect. Classified as Vapocoolant Device (product code MLY).

Submitted by Vapocoolshot, Inc. (Boca Raton, US). The FDA issued a Cleared decision on May 30, 2025 after a review of 185 days - an extended review cycle.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Vapocoolshot, Inc. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 127d · This submission: 185d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MLY Vapocoolant Device
Device Class -