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FDA 510(k)

D-LUX+

K-Number: K200809 · 2020-08-07

ApplicantDiaDent Group International
Decision Date2020-08-07
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

D-LUX+ is a medical device manufactured by DiaDent Group International. It received FDA 510(k) clearance on 2020-08-07 under approval number K200809. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the D-LUX+?

D-LUX+ is a medical device that received FDA 510(k) clearance on 2020-08-07. It is manufactured by DiaDent Group International. The 510(k) number is K200809.

When was D-LUX+ approved by the FDA?

D-LUX+ received FDA 510(k) clearance on 2020-08-07, under approval number K200809.

What company makes D-LUX+?

D-LUX+ is manufactured by DiaDent Group International.

What is the FDA product code for D-LUX+?

The FDA product code for D-LUX+ is EBZ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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