Cleared Special

K053392 - FUTURABOND NR SINGLE DOSE

K053392 is an FDA 510(k) clearance for FUTURABOND NR SINGLE DOSE, 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 10-day FDA review.

K053392 · Voco GmbH · Dental device
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Dec 2005
Decision
10d
Days
Class 2
Risk

K053392 is an FDA 510(k) clearance for the FUTURABOND NR SINGLE DOSE. 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 December 15, 2005 after a review of 10 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.

View all Voco GmbH devices

FDA 510(k) Submission Details - K053392

510(k) Number K053392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2005
Decision Date December 15, 2005
Days to Decision 10 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 127d · This submission: 10d
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 372
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K053392.
PORCELAIN PRIMER
K061322 · J. Morita USA, Inc. · Jun 2006
ADPER PROMPT, ADPER PROMPT L-POP
K060684 · 3M Espe AG Dental Products · Apr 2006
OPTIBOND ALL-IN-ONE
K060469 · Sybron Dental Specialties, Inc. · Mar 2006
MULTIPLE RESIN TOOTH BONDING AGENT
K052501 · Cosmedent, Inc. · Oct 2005
ECLIPSE BONDING AGENT
K051707 · Dentsply Intl. · Jul 2005
XENO ADHESIVE WITH ACTIVATOR
K051463 · Dentsply Intl. · Jul 2005