Cleared Traditional

K151619 - Prime&Bond Elect Universal Dental Adhesive

K151619 is the FDA 510(k) clearance for Prime&Bond Elect Universal Dental Adhesive by Dentsply International, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K151619 · Dentsply International, Inc. · Dental device
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Oct 2015
Decision
136d
Days
Class 2
Risk

K151619 is an FDA 510(k) clearance for the Prime&Bond Elect Universal Dental Adhesive. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Dentsply International, Inc. (York, US). The FDA issued a Cleared decision on October 30, 2015 after a review of 136 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 Dentsply International, Inc. devices

Submission Details

510(k) Number K151619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2015
Decision Date October 30, 2015
Days to Decision 136 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
9d slower than avg
Panel avg: 127d · This submission: 136d
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 K151619.
SHOFU MZ Primer Plus
K172106 · Shofu Dental Corporation · Aug 2017
HC Primer
K161891 · Shofu Dental Corporation · Nov 2016
All-Bond Universal w/BAC (not finalized)
K161051 · Bisco, Inc. · Sep 2016
BRUSH&BOND PLUS
K151518 · Parkell, Inc. · Sep 2015
G-Premio BOND
K143140 · GC America, Inc. · Apr 2015
EAZY PRIMER
K142848 · Parkell, Inc. · Feb 2015