Cleared Traditional

BOND-3 ADHESIVE (K020499) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K020499 · Jeneric/Pentron, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
67d
Days
Class 2
Risk

K020499 is an FDA 510(k) clearance for the BOND-3 ADHESIVE. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on April 22, 2002 after a review of 67 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 Jeneric/Pentron, Inc. devices

Submission Details

510(k) Number K020499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2002
Decision Date April 22, 2002
Days to Decision 67 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 127d · This submission: 67d
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 122
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K020499.
FINAL VARNISH LC
K030844 · Voco GmbH · Jun 2003
XENO III DENTAL ADHESIVE
K023776 · Dentsply Intl. · Jan 2003
IBOND GLUMA INSIDE
K022612 · Heraeus Kulzer, Inc. · Oct 2002
UNIFIL BOND
K013997 · GC America, Inc. · Feb 2002
MODIFICATION TO EXCITE
K011490 · Ivoclar North America, Inc. · Jun 2001
XSE
K011167 · 3M Company · May 2001