Cleared Traditional

K131734 - ALL-BOND UNIVERSAL SC (NOT FINALIZED)

K131734 is the FDA 510(k) clearance for ALL-BOND UNIVERSAL SC (NOT FINALIZED) by Bisco, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K131734 · Bisco, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
302d
Days
Class 2
Risk

K131734 is an FDA 510(k) clearance for the ALL-BOND UNIVERSAL SC (NOT FINALIZED). Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on April 11, 2014 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Bisco, Inc. devices

Submission Details

510(k) Number K131734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2013
Decision Date April 11, 2014
Days to Decision 302 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
175d slower than avg
Panel avg: 127d · This submission: 302d
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 183
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K131734.
All-Bond Universal w/BAC (not finalized)
K161051 · Bisco, Inc. · Sep 2016
G-Premio BOND
K143140 · GC America, Inc. · Apr 2015
FUTURABOND M+
K141610 · Voco GmbH · Aug 2014
PEAK Z
K131357 · Ultradent Products, Inc. · Sep 2013
FUTURABOND UNIVERSAL
K130486 · Voco GmbH · Jun 2013
DREAMBOND
K112118 · Bisco, Inc. · Nov 2011