FDA 510(k)

DentalJect

K-Number: K243654 · 2025-05-30

Decision Date2025-05-30

Product CodeMLY

DecisionSubstantially Equivalent

Device Summary

DentalJect is the device name listed in this FDA 510(k) record. The listed applicant is Vapocoolshot, Inc.. It received FDA 510(k) clearance on 2025-05-30 under 510(k) number K243654. The device is classified under product code MLY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DentalJect?

DentalJect is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Vapocoolshot, Inc.. The 510(k) number is K243654.

When did DentalJect receive FDA 510(k) clearance?

DentalJect received FDA 510(k) clearance on 2025-05-30, under 510(k) number K243654.

Who is the listed applicant for DentalJect?

The FDA 510(k) record lists Vapocoolshot, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DentalJect?

The FDA product code for DentalJect is MLY.

Other records listing Vapocoolshot, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201248Syringe Holder accessory K193349Vapocoolshot Mist

Related Devices (Code: MLY)

K232674PainFreeze IINuance Medical, LLC K203661CRYO Arctic, CRYO PenguinCryoscience North America, Inc.K202782num Vapocoolant623 Medical, LLC K201248Syringe Holder accessoryVapocoolshot, Inc.K193349Vapocoolshot MistVapocoolshot, Inc.K190161Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine SprayGebauer Company

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.