BruxZir Esthetic
K-Number: K213425 · 2021-11-17
ApplicantPrismatik Dentalcraft, Inc.
Decision Date2021-11-17
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 2021-11-17 under approval number K213425. 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 2021-11-17. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K213425.
When was BruxZir Esthetic approved by the FDA?
BruxZir Esthetic received FDA 510(k) clearance on 2021-11-17, under approval number K213425.
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.