BruxZir Steel
K-Number: K200131 · 2020-06-10
ApplicantPrismatik Dentalcraft, Inc.
Decision Date2020-06-10
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BruxZir Steel is a medical device manufactured by Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2020-06-10 under approval number K200131. 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 Steel?
BruxZir Steel is a medical device that received FDA 510(k) clearance on 2020-06-10. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K200131.
When was BruxZir Steel approved by the FDA?
BruxZir Steel received FDA 510(k) clearance on 2020-06-10, under approval number K200131.
What company makes BruxZir Steel?
BruxZir Steel is manufactured by Prismatik Dentalcraft, Inc..
What is the FDA product code for BruxZir Steel?
The FDA product code for BruxZir Steel 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.