Cleared Special

K141610 - FUTURABOND M+

K141610 is an FDA 510(k) clearance for FUTURABOND M+, manufactured by Voco GmbH. The device is a Class 2 Dental device with product code KLE cleared through the Special 510(k) pathway after a 46-day FDA review.

K141610 · Voco GmbH · Dental device
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Aug 2014
Decision
46d
Days
Class 2
Risk

K141610 is an FDA 510(k) clearance for the FUTURABOND M+. 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 August 1, 2014 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K141610

510(k) Number K141610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2014
Decision Date August 01, 2014
Days to Decision 46 days
Submission Type Special
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
82d faster than avg
Panel avg: 128d · This submission: 46d
Pathway characteristics
Modification to existing cleared device.

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 406
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K141610.
EAZY PRIMER
K142848 · Parkell, Inc. · Feb 2015
PREMIER ETCH
K141839 · Premier Dental Products Co. · Nov 2014
TENURE4G
K140537 · Den-Mat Holdings, LLC · Aug 2014
ALL-BOND UNIVERSAL SC (NOT FINALIZED)
K131734 · Bisco, Inc. · Apr 2014
ADHESE UNIVERSAL
K133318 · Ivoclar Vivadent, AG · Feb 2014
FUSION SINGLE LINK
K132923 · Angelus Industria DE Productos Odontologicos SA · Jan 2014
K141610 · FUTURABOND M+
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