Cleared Special

K050386 - PRIME & BOND NT DUAL CURE NANO-TECHNOLO...

K050386 is an FDA 510(k) clearance for PRIME & BOND NT DUAL CURE NANO-TECHNOLO..., manufactured by Dentsply International. The device is a Class 2 Dental device with product code KLE cleared through the Special 510(k) pathway after a 8-day FDA review.

K050386 · Dentsply International · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
8d
Days
Class 2
Risk

K050386 is an FDA 510(k) clearance for the PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Dentsply International (York, US). The FDA issued a Cleared decision on February 23, 2005 after a review of 8 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 International devices

FDA 510(k) Submission Details - K050386

510(k) Number K050386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2005
Decision Date February 23, 2005
Days to Decision 8 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
119d faster than avg
Panel avg: 127d · This submission: 8d
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 317
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K050386.
XENO ADHESIVE WITH ACTIVATOR
K051463 · Dentsply Intl. · Jul 2005
ALL-IN-ONE
K050647 · Bisco, Inc. · Apr 2005
BOSWORTH BOND
K043170 · Harry J. Bosworth Co. · Feb 2005
HERMES BOND 2
K043043 · 3M Espe AG Dental Products · Jan 2005
CLEARFIL TRI-S BOND
K042913 · Kuraray Medical, Inc. · Nov 2004
QUADRANT UNIT-1-BOND
K042806 · Cavex Holland BV · Nov 2004