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FDA 510(k)

ZMAXX Dental Zirconia Blanks

K-Number: K191631 · 2019-11-01

ApplicantZmaxx Bioceramics, LLC
Decision Date2019-11-01
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZMAXX Dental Zirconia Blanks is a medical device manufactured by Zmaxx Bioceramics, LLC. It received FDA 510(k) clearance on 2019-11-01 under approval number K191631. 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 ZMAXX Dental Zirconia Blanks?

ZMAXX Dental Zirconia Blanks is a medical device that received FDA 510(k) clearance on 2019-11-01. It is manufactured by Zmaxx Bioceramics, LLC. The 510(k) number is K191631.

When was ZMAXX Dental Zirconia Blanks approved by the FDA?

ZMAXX Dental Zirconia Blanks received FDA 510(k) clearance on 2019-11-01, under approval number K191631.

What company makes ZMAXX Dental Zirconia Blanks?

ZMAXX Dental Zirconia Blanks is manufactured by Zmaxx Bioceramics, LLC.

What is the FDA product code for ZMAXX Dental Zirconia Blanks?

The FDA product code for ZMAXX Dental Zirconia Blanks 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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