Cleared Traditional

K152443 - Vericore Gradient Temporary Disc

K152443 is an FDA 510(k) clearance for Vericore Gradient Temporary Disc, manufactured by Whip Mix Corporation. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 258-day FDA review.

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

FDA 510(k) Submission Details - K152443

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 128d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBG Device Classification - Class 2, Special Controls

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 170
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K152443.
Fixtemp C&B
K171729 · Dreve Dentamid GmbH · Dec 2017
PuRE PMMA Disc
K172281 · Quest Dental USA Corp. · Oct 2017
DD medical polymers
K153490 · Dental Direkt GmbH · May 2016
TelioCAD Multi
K153753 · Ivoclar Vivadent, Inc. · Apr 2016
DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR
K152215 · Dentalplus GmbH · Jan 2016
YAMAHACHI PMMA DISKS
K151764 · Yamahachi Dental Products USA, Inc. · Nov 2015