Cleared Special

K231347 - BruxZir™ TintEFX Coloring Liquid (FDA 510(k) Clearance)

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K231347 · Prismatik Dentalcraft, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
31d
Days
Class 2
Risk

K231347 is an FDA 510(k) clearance for the BruxZir™ TintEFX 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 June 9, 2023 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Prismatik Dentalcraft, Inc. devices

Submission Details

510(k) Number K231347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2023
Decision Date June 09, 2023
Days to Decision 31 days
Submission Type Special
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
96d faster than avg
Panel avg: 127d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 478
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