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FDA 510(k)

Purzir Dental Zirconia

K-Number: K193055 · 2020-05-13

Applicant3DBiocad
Decision Date2020-05-13
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Purzir Dental Zirconia is a medical device manufactured by 3DBiocad. It received FDA 510(k) clearance on 2020-05-13 under approval number K193055. 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 Purzir Dental Zirconia?

Purzir Dental Zirconia is a medical device that received FDA 510(k) clearance on 2020-05-13. It is manufactured by 3DBiocad. The 510(k) number is K193055.

When was Purzir Dental Zirconia approved by the FDA?

Purzir Dental Zirconia received FDA 510(k) clearance on 2020-05-13, under approval number K193055.

What company makes Purzir Dental Zirconia?

Purzir Dental Zirconia is manufactured by 3DBiocad.

What is the FDA product code for Purzir Dental Zirconia?

The FDA product code for Purzir Dental Zirconia is EIH.

Related Clinical Trials

NCT04695899 Zirconia Implants for Replacement of a Single Tooth ACTIVE_NOT_RECRUITING

Related Devices (Code: EIH)

K162677L- OVCRhondium, Ltd. K160079rainbow ShineGenoss Co., Ltd. K160203ADAMANT ZIRCONIA DISCAdamant Co., Ltd. K160262n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,Institut Straumann AG K152023Luminesse Shaded Zirconia SZTalladium, Inc. K153130Initial LiSi BlockGC America, Inc.

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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