Cleared Traditional

K150164 - Monobond Etch & Prime

K150164 is an FDA 510(k) clearance for Monobond Etch & Prime, manufactured by Ivoclar Vivadent, AG. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K150164

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
Combination Product No
PCCP Authorized No
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.

KLE Device Classification - Class 2, Special Controls

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 Consultant

Ivoclar Vivadent, Inc.
DONNA MARIE HARTNETT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KLE Agent, Tooth Bonding, Resin

All 372
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K150164.
iBond Universal & iBond Ceramic Primer
K150933 · Heraeus Kulzer, LLC, Mitsui Chemicals Group · Jul 2015
Jade 37% Phosphoric Acid Etchant Gel
K150696 · Dharma Research, Inc. · Jun 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
TENURE4G
K140537 · Den-Mat Holdings, LLC · Aug 2014