Cleared Traditional

K141839 - PREMIER ETCH

K141839 is the FDA 510(k) clearance for PREMIER ETCH by Premier Dental Products Co.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K141839 · Premier Dental Products Co. · Dental device
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Nov 2014
Decision
132d
Days
Class 2
Risk

K141839 is an FDA 510(k) clearance for the PREMIER ETCH. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Premier Dental Products Co. (Plymouth Meeting, US). The FDA issued a Cleared decision on November 17, 2014 after a review of 132 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 Premier Dental Products Co. devices

Submission Details

510(k) Number K141839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2014
Decision Date November 17, 2014
Days to Decision 132 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 127d · This submission: 132d
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 184
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K141839.
Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel
K172977 · Nanova Biomaterials, Inc. · Jan 2018
All-Bond Universal w/BAC (not finalized)
K161051 · Bisco, Inc. · Sep 2016
G-Premio BOND
K143140 · GC America, Inc. · Apr 2015
FUTURABOND M+
K141610 · Voco GmbH · Aug 2014
ALL-BOND UNIVERSAL SC (NOT FINALIZED)
K131734 · Bisco, Inc. · Apr 2014
PEAK Z
K131357 · Ultradent Products, Inc. · Sep 2013