FDA 510(k)

DentalJect

K号: K243654 · 2025-05-30

决定日期2025-05-30

产品代码MLY

决定实质等同

器械摘要

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.

常见问题

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.

列明Vapocoolshot, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K201248注射器夹配件 K193349Vapocoolshot 雾化吸入装置

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。