BruxZir® Radiant
K-Number: K240574 · 2024-03-20
ApplicantPrismatik Dentalcraft, Inc.
Decision Date2024-03-20
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BruxZir® Radiant is a medical device manufactured by Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2024-03-20 under approval number K240574. 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® Radiant?
BruxZir® Radiant is a medical device that received FDA 510(k) clearance on 2024-03-20. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K240574.
When was BruxZir® Radiant approved by the FDA?
BruxZir® Radiant received FDA 510(k) clearance on 2024-03-20, under approval number K240574.
What company makes BruxZir® Radiant?
BruxZir® Radiant is manufactured by Prismatik Dentalcraft, Inc..
What is the FDA product code for BruxZir® Radiant?
The FDA product code for BruxZir® Radiant 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.