Cleared Traditional

K130486 - FUTURABOND UNIVERSAL

K130486 is the FDA 510(k) clearance for FUTURABOND UNIVERSAL by Voco GmbH. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K130486 · Voco GmbH · Dental device
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Jun 2013
Decision
115d
Days
Class 2
Risk

K130486 is an FDA 510(k) clearance for the FUTURABOND UNIVERSAL. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on June 20, 2013 after a review of 115 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 Voco GmbH devices

Submission Details

510(k) Number K130486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2013
Decision Date June 20, 2013
Days to Decision 115 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 127d · This submission: 115d
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 189
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K130486.
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
DREAMBOND
K112118 · Bisco, Inc. · Nov 2011
ALL-BOUND 3
K102844 · Bisco, Inc. · Oct 2010
ALL-ETCH, ALL- ETCH WITH BAC
K101485 · Bisco, Inc. · Aug 2010