Cleared Special

ECLIPSE BONDING AGENT (K051707) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K051707 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
18d
Days
Class 2
Risk

K051707 is an FDA 510(k) clearance for the ECLIPSE BONDING AGENT. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on July 15, 2005 after a review of 18 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 Dentsply Intl. devices

Submission Details

510(k) Number K051707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2005
Decision Date July 15, 2005
Days to Decision 18 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
109d faster than avg
Panel avg: 127d · This submission: 18d
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 82
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K051707.
Acid Etchant
K172953 · American Orthodontics · Feb 2018
Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel
K172977 · Nanova Biomaterials, Inc. · Jan 2018
XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE
K070538 · Dentsply Intl. · Mar 2007
XENO ADHESIVE WITH ACTIVATOR
K051463 · Dentsply Intl. · Jul 2005
XENO III DENTAL ADHESIVE
K023776 · Dentsply Intl. · Jan 2003
XSE
K011167 · 3M Company · May 2001