BruxZir® NOW SRC
K-Number: K231940 · 2024-05-15
ApplicantPrismatik Dentalcraft, Inc.
Decision Date2024-05-15
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BruxZir® NOW SRC is a medical device manufactured by Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2024-05-15 under approval number K231940. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BruxZir® NOW SRC?
BruxZir® NOW SRC is a medical device that received FDA 510(k) clearance on 2024-05-15. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K231940.
When was BruxZir® NOW SRC approved by the FDA?
BruxZir® NOW SRC received FDA 510(k) clearance on 2024-05-15, under approval number K231940.
What company makes BruxZir® NOW SRC?
BruxZir® NOW SRC is manufactured by Prismatik Dentalcraft, Inc..
What is the FDA product code for BruxZir® NOW SRC?
The FDA product code for BruxZir® NOW SRC is NHA.
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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.