Cleared Special

K142670 - Vericore Zirconia Blanks

K142670 is an FDA 510(k) clearance for Vericore Zirconia Blanks, manufactured by Whip Mix Corporation. The device is a Class 2 Dental device with product code EIH cleared through the Special 510(k) pathway after a 33-day FDA review.

K142670 · Whip Mix Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
33d
Days
Class 2
Risk

K142670 is an FDA 510(k) clearance for the Vericore Zirconia Blanks. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Whip Mix Corporation (Louisville, US). The FDA issued a Cleared decision on October 22, 2014 after a review of 33 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 Whip Mix Corporation devices

FDA 510(k) Submission Details - K142670

510(k) Number K142670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2014
Decision Date October 22, 2014
Days to Decision 33 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 127d · This submission: 33d
Pathway characteristics
Modification to existing cleared device.

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 286
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K142670.
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ZIRTOUGH
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K131534 · Kuraray Noritake Dental, Inc. · Oct 2013