BruxZir® Esthetic
K-Number: K240882 · 2024-05-01
ApplicantPrismatik Dentalcraft, Inc.
Decision Date2024-05-01
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BruxZir® Esthetic is a medical device manufactured by Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2024-05-01 under approval number K240882. 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?
BruxZir® Esthetic is a medical device that received FDA 510(k) clearance on 2024-05-01. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K240882.
When was BruxZir® Esthetic approved by the FDA?
BruxZir® Esthetic received FDA 510(k) clearance on 2024-05-01, under approval number K240882.
What company makes BruxZir® Esthetic?
BruxZir® Esthetic is manufactured by Prismatik Dentalcraft, Inc..
What is the FDA product code for BruxZir® Esthetic?
The FDA product code for BruxZir® Esthetic 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.