BruxZir TintEFX Coloring Liquid
K-Number: K231347 · 2023-06-09
ApplicantPrismatik Dentalcraft, Inc.
Decision Date2023-06-09
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BruxZir TintEFX Coloring Liquid is a medical device manufactured by Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2023-06-09 under approval number K231347. 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 TintEFX Coloring Liquid?
BruxZir TintEFX Coloring Liquid is a medical device that received FDA 510(k) clearance on 2023-06-09. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K231347.
When was BruxZir TintEFX Coloring Liquid approved by the FDA?
BruxZir TintEFX Coloring Liquid received FDA 510(k) clearance on 2023-06-09, under approval number K231347.
What company makes BruxZir TintEFX Coloring Liquid?
BruxZir TintEFX Coloring Liquid is manufactured by Prismatik Dentalcraft, Inc..
What is the FDA product code for BruxZir TintEFX Coloring Liquid?
The FDA product code for BruxZir TintEFX Coloring Liquid is EIH.
Other Devices by Prismatik Dentalcraft, Inc.
Related Devices (Code: EIH)
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.