Cleared Traditional

K051463 - XENO ADHESIVE WITH ACTIVATOR

K051463 is an FDA 510(k) clearance for XENO ADHESIVE WITH ACTIVATOR, manufactured by Dentsply Intl.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K051463 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
39d
Days
Class 2
Risk

K051463 is an FDA 510(k) clearance for the XENO ADHESIVE WITH ACTIVATOR. 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 12, 2005 after a review of 39 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 Dentsply Intl. devices

FDA 510(k) Submission Details - K051463

510(k) Number K051463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2005
Decision Date July 12, 2005
Days to Decision 39 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 127d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 380
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K051463.
REVENEER CERAMIC REPAIR SYSTEM
K052189 · Schutz-Dental GmbH · Oct 2005
CLEARFIL TRI-S BOND SINGLE DOSE
K051796 · Kuraray Medical Kurashiki Plant · Aug 2005
ECLIPSE BONDING AGENT
K051707 · Dentsply Intl. · Jul 2005
SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092
K051050 · Schutz-Dental GmbH · Jun 2005
IBOND NEXT GENERATION
K051006 · Heraeus Kulzer,GmbH · Jun 2005
ALL-IN-ONE
K050647 · Bisco, Inc. · Apr 2005