Cleared Traditional

K133318 - ADHESE UNIVERSAL

K133318 is the FDA 510(k) clearance for ADHESE UNIVERSAL by Ivoclar Vivadent, AG. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K133318 · Ivoclar Vivadent, AG · Dental device
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Feb 2014
Decision
106d
Days
Class 2
Risk

K133318 is an FDA 510(k) clearance for the ADHESE UNIVERSAL. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Ivoclar Vivadent, AG (Amherst, US). The FDA issued a Cleared decision on February 11, 2014 after a review of 106 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 Ivoclar Vivadent, AG devices

Submission Details

510(k) Number K133318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2013
Decision Date February 11, 2014
Days to Decision 106 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
21d faster than avg
Panel avg: 127d · This submission: 106d
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 K133318.
PREMIER ETCH
K141839 · Premier Dental Products Co. · Nov 2014
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
PREMIER CERAMIC PRIMER
K131212 · Premier Dental Products Co. · Aug 2013
FUTURABOND UNIVERSAL
K130486 · Voco GmbH · Jun 2013