Cleared Traditional

K082753 - FUTURABOND M/FUTURABOND M SINGLE DOSE

K082753 is the FDA 510(k) clearance for FUTURABOND M/FUTURABOND M SINGLE DOSE by Voco GmbH. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K082753 · Voco GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
66d
Days
Class 2
Risk

K082753 is an FDA 510(k) clearance for the FUTURABOND M/FUTURABOND M 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 November 24, 2008 after a review of 66 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Voco GmbH devices

Submission Details

510(k) Number K082753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2008
Decision Date November 24, 2008
Days to Decision 66 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
61d faster than avg
Panel avg: 127d · This submission: 66d
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 248
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K082753.
ADHESE ONE F
K090941 · Ivoclar Vivadent, Inc. · Jul 2009
MONOBOND PLUS
K090826 · Ivoclar Vivadent, Inc. · May 2009
BEAUTIBOND
K082744 · Shofu Dental Corp. · Dec 2008
G-BOND PLUS
K082768 · GC America, Inc. · Oct 2008
FL BOND II
K071452 · Shofu Dental Corp. · Jul 2007
FUTURABOND DC/SINGLE DOSE
K070723 · Voco GmbH · Jun 2007