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510(k) K243654

DentalJect by Vapocoolshot, Inc. — Product Code MLY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2025
Date Received
November 26, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vapocoolant Device
Device Class
Class U
Regulation Number
Review Panel
PM
Submission Type

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  • K172203 — CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray (October 18, 2017)
  • K162218 — Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model (November 22, 2016)