Cleared Traditional

Vericore Gradient Temporary Disc (K152443) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K152443 · Whip Mix Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
258d
Days
Class 2
Risk

K152443 is an FDA 510(k) clearance for the Vericore Gradient Temporary Disc. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Whip Mix Corporation (Louisville, US). The FDA issued a Cleared decision on May 11, 2016 after a review of 258 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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 Whip Mix Corporation devices

Submission Details

510(k) Number K152443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2015
Decision Date May 11, 2016
Days to Decision 258 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 127d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 63
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K152443.
Harvest Dental Polymer Blocks
K180578 · Harvest Dental Products, LLC · Dec 2018
Resin for Temporary Crown & Bridge
K180657 · Dentis Co., Ltd. · Dec 2018
TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT
K180562 · Zirkonzahn GmbH · Jun 2018
MSN-006
K141562 · GC America, Inc. · Sep 2014
STRUCTUR 3
K120779 · Voco GmbH · Jun 2012
TEMPORARY C&B COMPOSITE
K091894 · Voco GmbH · Jul 2009