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FDA 510(k)

Insure® Universal; Insure® Universal Automix

K-Number: K240714 · 2024-07-24

ApplicantCosmedent, Inc.
Decision Date2024-07-24
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Cosmedent, 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.

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Related Devices (Code: EMA)

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.

K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.K252606Bifix Veneer LC, Bifix Veneer Try-InVoco GmbH

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.

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