BruxZir Opaque Coloring Liquid
K-Number: K220960 · 2022-06-29
ApplicantPrismatik Dentalcraft, Inc.
Decision Date2022-06-29
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BruxZir Opaque Coloring Liquid is a medical device manufactured by Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2022-06-29 under approval number K220960. 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 Opaque Coloring Liquid?
BruxZir Opaque Coloring Liquid is a medical device that received FDA 510(k) clearance on 2022-06-29. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K220960.
When was BruxZir Opaque Coloring Liquid approved by the FDA?
BruxZir Opaque Coloring Liquid received FDA 510(k) clearance on 2022-06-29, under approval number K220960.
What company makes BruxZir Opaque Coloring Liquid?
BruxZir Opaque Coloring Liquid is manufactured by Prismatik Dentalcraft, Inc..
What is the FDA product code for BruxZir Opaque Coloring Liquid?
The FDA product code for BruxZir Opaque 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.