BruxZir® NOW
K-Number: K252446 · 2025-09-03
ApplicantPrismatik Dentalcraft, Inc.
Decision Date2025-09-03
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 2025-09-03 under approval number K252446. 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 2025-09-03. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K252446.
When was BruxZir® NOW approved by the FDA?
BruxZir® NOW received FDA 510(k) clearance on 2025-09-03, under approval number K252446.
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.