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FDA 510(k)

Duranext Abutments

K-Number: K200355 · 2020-07-22

ApplicantElegant Dental Corp.
Decision Date2020-07-22
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Duranext Abutments is a medical device manufactured by Elegant Dental Corp.. It received FDA 510(k) clearance on 2020-07-22 under approval number K200355. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Duranext Abutments?

Duranext Abutments is a medical device that received FDA 510(k) clearance on 2020-07-22. It is manufactured by Elegant Dental Corp.. The 510(k) number is K200355.

When was Duranext Abutments approved by the FDA?

Duranext Abutments received FDA 510(k) clearance on 2020-07-22, under approval number K200355.

What company makes Duranext Abutments?

Duranext Abutments is manufactured by Elegant Dental Corp..

What is the FDA product code for Duranext Abutments?

The FDA product code for Duranext Abutments is NHA.

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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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