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FDA 510(k)

D-LUX

K-Number: K130163 · 2013-08-16

ApplicantDiaDent Group International
Decision Date2013-08-16
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

D-LUX is the device name listed in this FDA 510(k) record. The listed applicant is DiaDent Group International. It received FDA 510(k) clearance on 2013-08-16 under 510(k) number K130163. 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 2013-08-16. The listed applicant is DiaDent Group International. The 510(k) number is K130163.

When did D-LUX receive FDA 510(k) clearance?

D-LUX received FDA 510(k) clearance on 2013-08-16, under 510(k) number K130163.

Who is the listed applicant for D-LUX?

The FDA 510(k) record lists DiaDent Group International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for D-LUX?

The FDA product code for D-LUX is EBZ.

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Related Devices (Code: EBZ)

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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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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