FDA 510(k)

Insure® Universal; Insure® Universal Automix

K-Number: K240714 · 2024-07-24

Decision Date2024-07-24

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Insure® Universal; Insure® Universal Automix is a medical device manufactured by Cosmedent, Inc.. It received FDA 510(k) clearance on 2024-07-24 under approval 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. It is manufactured by Cosmedent, Inc.. The 510(k) number is K240714.

When was Insure® Universal; Insure® Universal Automix approved by the FDA?

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

What company makes Insure® Universal; Insure® Universal Automix?

Insure® Universal; Insure® Universal Automix is manufactured by Cosmedent, Inc..

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

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

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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.