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FDA 510(k)

BruxZir GT (Gum Tissue) Color

K-Number: K191903 · 2019-11-22

ApplicantPrismatik Dentalcraft, Inc.
Decision Date2019-11-22
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BruxZir GT (Gum Tissue) Color is a medical device manufactured by Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2019-11-22 under approval number K191903. 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 BruxZir GT (Gum Tissue) Color?

BruxZir GT (Gum Tissue) Color is a medical device that received FDA 510(k) clearance on 2019-11-22. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K191903.

When was BruxZir GT (Gum Tissue) Color approved by the FDA?

BruxZir GT (Gum Tissue) Color received FDA 510(k) clearance on 2019-11-22, under approval number K191903.

What company makes BruxZir GT (Gum Tissue) Color?

BruxZir GT (Gum Tissue) Color is manufactured by Prismatik Dentalcraft, Inc..

What is the FDA product code for BruxZir GT (Gum Tissue) Color?

The FDA product code for BruxZir GT (Gum Tissue) Color is EIH.

Related Clinical Trials

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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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