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FDA 510(k)

Evogue Dental Unit

K-Number: K152100 · 2016-01-22

Decision Date2016-01-22
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Evogue Dental Unit is a medical device manufactured by Takara Belmont Corporation. It received FDA 510(k) clearance on 2016-01-22 under approval number K152100. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Evogue Dental Unit?

Evogue Dental Unit is a medical device that received FDA 510(k) clearance on 2016-01-22. It is manufactured by Takara Belmont Corporation. The 510(k) number is K152100.

When was Evogue Dental Unit approved by the FDA?

Evogue Dental Unit received FDA 510(k) clearance on 2016-01-22, under approval number K152100.

What company makes Evogue Dental Unit?

Evogue Dental Unit is manufactured by Takara Belmont Corporation.

What is the FDA product code for Evogue Dental Unit?

The FDA product code for Evogue Dental Unit is EIA.

Other Devices by Takara Belmont Corporation

Related Devices (Code: EIA)

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.