Cleared Special

K141788 - OBSIDIAN MILLING BLOCKS

K141788 is the FDA 510(k) clearance for OBSIDIAN MILLING BLOCKS by Prismatik Dentalcraft, Inc.. It is a Class 2 Dental device (product code EIH) cleared through the Special 510(k) pathway after a 49-day FDA review.

K141788 · Prismatik Dentalcraft, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
49d
Days
Class 2
Risk

K141788 is an FDA 510(k) clearance for the OBSIDIAN MILLING BLOCKS. 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 August 20, 2014 after a review of 49 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 K141788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2014
Decision Date August 20, 2014
Days to Decision 49 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
78d faster than avg
Panel avg: 127d · This submission: 49d
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 217
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K141788.
BruxZir Anterior Milling Blanks
K150872 · Prismatik Dentalcraft, Inc. · Jul 2015
BruxZir Anterior
K143330 · Prismatik Dentalcraft, Inc. · Dec 2014
OBSIDIAN PRESS (ALL CERAMIC AND POM)
K141887 · Prismatik Dentalcraft, Inc. · Nov 2014
UNIVERSAL PASTE STAINS AND GLAZE
K130604 · Prismatik Dentalcraft, Inc. · Sep 2013
BRUXZIR SHADED
K130924 · Prismatik Dentalcraft, Inc. · May 2013
IRIS - HIGH STRENGTH GLASS CERAMIC
K123615 · Dentsply Intl. · Feb 2013