BruxZir® Esthetic NOW
K-Number: K250223 · 2025-02-25
ApplicantPrismatik Dentalcraft, Inc.
Decision Date2025-02-25
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BruxZir® Esthetic NOW is a medical device manufactured by Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2025-02-25 under approval number K250223. 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® Esthetic NOW?
BruxZir® Esthetic NOW is a medical device that received FDA 510(k) clearance on 2025-02-25. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K250223.
When was BruxZir® Esthetic NOW approved by the FDA?
BruxZir® Esthetic NOW received FDA 510(k) clearance on 2025-02-25, under approval number K250223.
What company makes BruxZir® Esthetic NOW?
BruxZir® Esthetic NOW is manufactured by Prismatik Dentalcraft, Inc..
What is the FDA product code for BruxZir® Esthetic NOW?
The FDA product code for BruxZir® Esthetic 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.