Cleared Traditional

K022973 - ADHESIVE 14

K022973 is an FDA 510(k) clearance for ADHESIVE 14, manufactured by Ab Ardent. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K022973 · Ab Ardent · Dental device
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Nov 2002
Decision
77d
Days
Class 2
Risk

K022973 is an FDA 510(k) clearance for the ADHESIVE 14. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Ab Ardent (Tonawanda, US). The FDA issued a Cleared decision on November 22, 2002 after a review of 77 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 Ab Ardent devices

FDA 510(k) Submission Details - K022973

510(k) Number K022973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2002
Decision Date November 22, 2002
Days to Decision 77 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 127d · This submission: 77d
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 337
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K022973.
CLEARFIL SILANE KIT
K024356 · Kuraray Medical, Inc. · Mar 2003
CLEARFIL SE BOND PLUS
K023842 · Kuraray Medical, Inc. · Feb 2003
XENO III DENTAL ADHESIVE
K023776 · Dentsply Intl. · Jan 2003
IBOND GLUMA INSIDE
K022612 · Heraeus Kulzer, Inc. · Oct 2002
PQ1
K023042 · Ultradent Products, Inc. · Oct 2002
CLEARFIL SA PRIMER
K021427 · Kuraray Medical, Inc. · Jun 2002