Cleared Special

BruxZir? Shaded 16 PLUS

K254283 · Prismatik Dentalcraft, Inc. · Dental
Jan 2026
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K254283 is an FDA 510(k) clearance for the BruxZir? Shaded 16 PLUS, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Prismatik Dentalcraft, Inc. (Irvine, US). The FDA issued a Cleared decision on January 30, 2026, 30 days after receiving the submission on December 31, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K254283 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 2025
Decision Date January 30, 2026
Days to Decision 30 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EIH — Powder, Porcelain
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6660

Similar Devices — EIH Powder, Porcelain

All 477
IPS e.max Zirconia
K253953 · Ivoclar Vivadent, Inc. · Mar 2026
Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series
K253973 · Liaoning Upcera Co., Ltd. · Jan 2026
Glass Ceramic
K252789 · Shenzhen Xiangtong Co., Ltd. · Dec 2025
BruxZir? NOW
K252446 · Prismatik Dentalcraft, Inc. · Sep 2025
DenMat Multilayered Zirconia Disc
K251593 · Denmat Holding, LLC · Aug 2025
ARENA Star, Galaxy Star
K250063 · Arum Dentistry Co., Ltd. · Jul 2025