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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2026-01-30 under 510(k) 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. The listed applicant is Prismatik Dentalcraft, Inc.. The 510(k) number is K254283.

When did BruxZir® Shaded 16 PLUS receive FDA 510(k) clearance?

BruxZir® Shaded 16 PLUS received FDA 510(k) clearance on 2026-01-30, under 510(k) number K254283.

Who is the listed applicant for BruxZir® Shaded 16 PLUS?

The FDA 510(k) record lists Prismatik Dentalcraft, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BruxZir® Shaded 16 PLUS?

The FDA product code for BruxZir® Shaded 16 PLUS is EIH.

Other records listing Prismatik Dentalcraft, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: EIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba DandyK260918Zolid LunarisAmann Girrbach AGK260859Rosetta SM, Rosetta SPHass Corp.K253191DCMhotbond zirconDental Creativ Management GmbH

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.

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