BruxZir NOW
K-Number: K220816 · 2022-08-02
ApplicantPrismatik Dentalcraft, Inc.
Decision Date2022-08-02
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BruxZir NOW is a medical device manufactured by Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2022-08-02 under approval number K220816. 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 NOW?
BruxZir NOW is a medical device that received FDA 510(k) clearance on 2022-08-02. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K220816.
When was BruxZir NOW approved by the FDA?
BruxZir NOW received FDA 510(k) clearance on 2022-08-02, under approval number K220816.
What company makes BruxZir NOW?
BruxZir NOW is manufactured by Prismatik Dentalcraft, Inc..
What is the FDA product code for BruxZir NOW?
The FDA product code for BruxZir NOW 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.