Cleared Special

K063780 - ACE BOND SE

K063780 is the FDA 510(k) clearance for ACE BOND SE by Bisco, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Special 510(k) pathway after a 29-day FDA review.

K063780 · Bisco, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
29d
Days
Class 2
Risk

K063780 is an FDA 510(k) clearance for the ACE BOND SE. 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 January 19, 2007 after a review of 29 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 Bisco, Inc. devices

Submission Details

510(k) Number K063780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2006
Decision Date January 19, 2007
Days to Decision 29 days
Submission Type Special
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
98d faster than avg
Panel avg: 127d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K063780.
FUTURABOND DC/SINGLE DOSE
K070723 · Voco GmbH · Jun 2007
ADHESE ONE
K070646 · Ivoclar Vivadent, Inc. · May 2007
XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE
K070538 · Dentsply Intl. · Mar 2007
PEAK SE, MODEL 5135
K063558 · Ultradent Products, Inc. · Dec 2006
PEAK BOND, MODEL 5133
K063557 · Ultradent Products, Inc. · Dec 2006
HKBOND 2006
K063062 · Heraeus Kulzer, Inc. · Dec 2006