Cleared Traditional

K133318 - ADHESE UNIVERSAL

K133318 is an FDA 510(k) clearance for ADHESE UNIVERSAL, 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 106-day FDA review.

K133318 · Ivoclar Vivadent, AG · Dental device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K133318

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
Combination Product No
PCCP Authorized No
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.

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 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 K133318.
TENURE4G
K140537 · Den-Mat Holdings, LLC · Aug 2014
FUTURABOND M+
K141610 · Voco GmbH · Aug 2014
ALL-BOND UNIVERSAL SC (NOT FINALIZED)
K131734 · Bisco, Inc. · Apr 2014
FUSION SINGLE LINK
K132923 · Angelus Industria DE Productos Odontologicos SA · Jan 2014
K-ETCHANT SYRINGE
K133078 · Kuraray Noritake Dental, Inc. · Dec 2013
CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND
K132450 · Kuraray Noritake Dental, Inc. · Nov 2013