Cleared Traditional

K181476 - Prime&Bond active Universal Adhesive

K181476 is the FDA 510(k) clearance for Prime&Bond active Universal Adhesive by Dentsply Sirona. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K181476 · Dentsply Sirona · Dental device
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Sep 2018
Decision
115d
Days
Class 2
Risk

K181476 is an FDA 510(k) clearance for the Prime&Bond active Universal Adhesive. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Dentsply Sirona (York, US). The FDA issued a Cleared decision on September 28, 2018 after a review of 115 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 Sirona devices

Submission Details

510(k) Number K181476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2018
Decision Date September 28, 2018
Days to Decision 115 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
12d faster than avg
Panel avg: 127d · This submission: 115d
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 K181476.
GC Acrylic Primer
K180917 · GC America, Inc. · Nov 2018
OptiBond eXTRa Universal
K182162 · Kerr Corporation · Nov 2018
BracePaste MTP Light Cure Primer
K181910 · American Orthodontics · Oct 2018
BeautiBond Universal
K180803 · Shofu Dental Corporation · Sep 2018
Meta P&Bond
K180802 · Meta Biomed Co., Ltd. · Aug 2018
Acid Etchant
K172953 · American Orthodontics · Feb 2018