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FDA 510(k)

BRILLIANT EVERGLOW

K-Number: K152927 · 2016-04-28

Decision Date2016-04-28
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BRILLIANT EVERGLOW is a medical device manufactured by Coltene/Whaledent AG. It received FDA 510(k) clearance on 2016-04-28 under approval number K152927. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRILLIANT EVERGLOW?

BRILLIANT EVERGLOW is a medical device that received FDA 510(k) clearance on 2016-04-28. It is manufactured by Coltene/Whaledent AG. The 510(k) number is K152927.

When was BRILLIANT EVERGLOW approved by the FDA?

BRILLIANT EVERGLOW received FDA 510(k) clearance on 2016-04-28, under approval number K152927.

What company makes BRILLIANT EVERGLOW?

BRILLIANT EVERGLOW is manufactured by Coltene/Whaledent AG.

What is the FDA product code for BRILLIANT EVERGLOW?

The FDA product code for BRILLIANT EVERGLOW is EBF.

Other Devices by Coltene/Whaledent AG

Related Devices (Code: EBF)

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.