Cleared Traditional

K142848 - EAZY PRIMER

K142848 is the FDA 510(k) clearance for EAZY PRIMER by Parkell, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K142848 · Parkell, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
147d
Days
Class 2
Risk

K142848 is an FDA 510(k) clearance for the EAZY PRIMER. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Parkell, Inc. (Edgewood, US). The FDA issued a Cleared decision on February 24, 2015 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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 Parkell, Inc. devices

Submission Details

510(k) Number K142848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2014
Decision Date February 24, 2015
Days to Decision 147 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
20d slower than avg
Panel avg: 127d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 248
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K142848.
Prime&Bond Elect Universal Dental Adhesive
K151619 · Dentsply International, Inc. · Oct 2015
BRUSH&BOND PLUS
K151518 · Parkell, Inc. · Sep 2015
G-Premio BOND
K143140 · GC America, Inc. · Apr 2015
PREMIER ETCH
K141839 · Premier Dental Products Co. · Nov 2014
FUTURABOND M+
K141610 · Voco GmbH · Aug 2014
ALL-BOND UNIVERSAL SC (NOT FINALIZED)
K131734 · Bisco, Inc. · Apr 2014