Cleared Traditional

K150164 - Monobond Etch & Prime

K150164 is the FDA 510(k) clearance for Monobond Etch & Prime by Ivoclar Vivadent, AG. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K150164 · Ivoclar Vivadent, AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
67d
Days
Class 2
Risk

K150164 is an FDA 510(k) clearance for the Monobond Etch & Prime. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Ivoclar Vivadent, AG (Schaan, LI). The FDA issued a Cleared decision on April 3, 2015 after a review of 67 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ivoclar Vivadent, AG devices

Submission Details

510(k) Number K150164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2015
Decision Date April 03, 2015
Days to Decision 67 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 127d · This submission: 67d
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 249
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K150164.
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
EAZY PRIMER
K142848 · Parkell, Inc. · Feb 2015
PREMIER ETCH
K141839 · Premier Dental Products Co. · Nov 2014
FUTURABOND M+
K141610 · Voco GmbH · Aug 2014