Cleared Traditional

K230262 - BruxZir™ Incisal Coloring Liquid

K230262 is an FDA 510(k) clearance for BruxZir Incisal Coloring Liquid, manufactured by Prismatik Dentalcraft, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K230262 · Prismatik Dentalcraft, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
105d
Days
Class 2
Risk

K230262 is an FDA 510(k) clearance for the BruxZir™ Incisal Coloring Liquid. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Prismatik Dentalcraft, Inc. (Irvine, US). The FDA issued a Cleared decision on May 16, 2023 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Prismatik Dentalcraft, Inc. devices

FDA 510(k) Submission Details - K230262

510(k) Number K230262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2023
Decision Date May 16, 2023
Days to Decision 105 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 127d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EIH Powder, Porcelain

All 400
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K230262.
BruxZir™ TintEFX Coloring Liquid
K231347 · Prismatik Dentalcraft, Inc. · Jun 2023
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K223192 · Shenzhen Xiangtong Co., Ltd. · Mar 2023
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