Cleared Traditional

K020499 - BOND-3 ADHESIVE

K020499 is an FDA 510(k) clearance for BOND-3 ADHESIVE, manufactured by Jeneric/Pentron, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 67-day FDA review.

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

FDA 510(k) Submission Details - K020499

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 128d · This submission: 67d
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 388
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K020499.
CLEARFIL SA PRIMER
K021427 · Kuraray Medical, Inc. · Jun 2002
PULPDENT GLAZE II
K020514 · Pulpdent Corporation · May 2002
SIMPLICITY
K020570 · Apex Dental Materials, Inc. · Apr 2002
XR PRIMER 2
K020303 · Kerr Dental Materials Center · Apr 2002
ADPER PROMPT
K020946 · 3M Espe AG Dental Products · Apr 2002
TOUCH&BOND-PLUS
K020239 · Parkell, Inc. · Mar 2002