FDA 510(k)

Insure® 通用型；Insure® 通用型自动混合型

K号: K240714 · 2024-07-24

决定日期2024-07-24

产品代码EMA

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决定实质等同

器械摘要

Insure® Universal; Insure® Universal Automix is the device name listed in this FDA 510(k) record. The listed applicant is Cosmedent, Inc.. It received FDA 510(k) clearance on 2024-07-24 under 510(k) number K240714. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Insure® Universal; Insure® Universal Automix?

Insure® Universal; Insure® Universal Automix is a medical device that received FDA 510(k) clearance on 2024-07-24. The listed applicant is Cosmedent, Inc.. The 510(k) number is K240714.

When did Insure® Universal; Insure® Universal Automix receive FDA 510(k) clearance?

Insure® Universal; Insure® Universal Automix received FDA 510(k) clearance on 2024-07-24, under 510(k) number K240714.

Who is the listed applicant for Insure® Universal; Insure® Universal Automix?

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

What is the FDA product code for Insure® Universal; Insure® Universal Automix?

The FDA product code for Insure® Universal; Insure® Universal Automix is EMA.

列明Cosmedent, Inc.为申报人的其他记录

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K222435Renamel® Microhybrid ;Renamel® 流动微混合 K211259Renamel Bulkfill K172707Renamel Microfill K163480Renamel NANO +plus

官方来源

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