BruxZir® Shaded 16 PLUS
K-Number: K254283 · 2026-01-30
ApplicantPrismatik Dentalcraft, Inc.
Decision Date2026-01-30
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BruxZir® Shaded 16 PLUS is a medical device manufactured by Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2026-01-30 under approval number K254283. 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® Shaded 16 PLUS?
BruxZir® Shaded 16 PLUS is a medical device that received FDA 510(k) clearance on 2026-01-30. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K254283.
When was BruxZir® Shaded 16 PLUS approved by the FDA?
BruxZir® Shaded 16 PLUS received FDA 510(k) clearance on 2026-01-30, under approval number K254283.
What company makes BruxZir® Shaded 16 PLUS?
BruxZir® Shaded 16 PLUS is manufactured by Prismatik Dentalcraft, Inc..
What is the FDA product code for BruxZir® Shaded 16 PLUS?
The FDA product code for BruxZir® Shaded 16 PLUS 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.