Cleared Special

BruxZir? NOW

K252446 · Prismatik Dentalcraft, Inc. · Dental
Sep 2025
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K252446 is an FDA 510(k) clearance for the BruxZir? NOW, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Prismatik Dentalcraft, Inc. (Irvine, US). The FDA issued a Cleared decision on September 3, 2025, 30 days after receiving the submission on August 4, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K252446 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2025
Decision Date September 03, 2025
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

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