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FDA 510(k)

EthanZir Zirconia

K-Number: K191304 · 2019-11-04

ApplicantBesorah Dental Solutions NZ Limited
Decision Date2019-11-04
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EthanZir Zirconia is a medical device manufactured by Besorah Dental Solutions NZ Limited. It received FDA 510(k) clearance on 2019-11-04 under approval number K191304. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EthanZir Zirconia?

EthanZir Zirconia is a medical device that received FDA 510(k) clearance on 2019-11-04. It is manufactured by Besorah Dental Solutions NZ Limited. The 510(k) number is K191304.

When was EthanZir Zirconia approved by the FDA?

EthanZir Zirconia received FDA 510(k) clearance on 2019-11-04, under approval number K191304.

What company makes EthanZir Zirconia?

EthanZir Zirconia is manufactured by Besorah Dental Solutions NZ Limited.

What is the FDA product code for EthanZir Zirconia?

The FDA product code for EthanZir Zirconia is EIH.

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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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