Cleared Traditional

K132923 - FUSION SINGLE LINK

K132923 is an FDA 510(k) clearance for FUSION SINGLE LINK, manufactured by Angelus Industria DE Productos Odontologicos SA. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K132923 · Angelus Industria DE Productos Odontologicos SA · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
107d
Days
Class 2
Risk

K132923 is an FDA 510(k) clearance for the FUSION SINGLE LINK. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Angelus Industria DE Productos Odontologicos SA (Aventura, US). The FDA issued a Cleared decision on January 3, 2014 after a review of 107 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 Angelus Industria DE Productos Odontologicos SA devices

FDA 510(k) Submission Details - K132923

510(k) Number K132923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2013
Decision Date January 03, 2014
Days to Decision 107 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
20d faster than avg
Panel avg: 127d · This submission: 107d
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 337
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K132923.
FUTURABOND M+
K141610 · Voco GmbH · Aug 2014
ALL-BOND UNIVERSAL SC (NOT FINALIZED)
K131734 · Bisco, Inc. · Apr 2014
ADHESE UNIVERSAL
K133318 · Ivoclar Vivadent, AG · Feb 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
PEAK Z
K131357 · Ultradent Products, Inc. · Sep 2013