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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vapocoolant Device
510(k) Number K243654
Device Name DentalJect
Applicant
Vapocoolshot, Inc.
950 Peninsula Corporate Circle
Suite 2011
Boca Raton,  FL  33487
Applicant Contact Jacob Leibovici
Correspondent
Vapocoolshot, Inc.
950 Peninsula Corporate Circle
Suite 2011
Boca Raton,  FL  33487
Correspondent Contact Michal Lyzwa
Classification Product Code
MLY  
Date Received11/26/2024
Decision Date 05/30/2025
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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