DentalJect— 510(k) K243654

Substantially Equivalent

Vapocoolshot, Inc.

FDA 510(k) clearance K243654 for DentalJect, Substantially Equivalent on 2025-05-30. Applicant: Vapocoolshot, Inc.. Device class: Unclassified.

Clearance details

Applicant: Vapocoolshot, Inc.
Product code: Code MLY
Device class: Unclassified
Advisory panel: Unknown
Date received: 2024-11-26
Decision date: 2025-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

Download summary PDF View on FDA.gov ↗

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