Cleared Traditional

K020303 - XR PRIMER 2

K020303 is an FDA 510(k) clearance for XR PRIMER 2, manufactured by Kerr Dental Materials Center. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K020303 · Kerr Dental Materials Center · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
80d
Days
Class 2
Risk

K020303 is an FDA 510(k) clearance for the XR PRIMER 2. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Kerr Dental Materials Center (Orange, US). The FDA issued a Cleared decision on April 19, 2002 after a review of 80 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 Kerr Dental Materials Center devices

FDA 510(k) Submission Details - K020303

510(k) Number K020303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2002
Decision Date April 19, 2002
Days to Decision 80 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
47d faster than avg
Panel avg: 127d · This submission: 80d
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 343
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K020303.
CLEARFIL SA PRIMER
K021427 · Kuraray Medical, Inc. · Jun 2002
PULPDENT GLAZE II
K020514 · Pulpdent Corporation · May 2002
BOND-3 ADHESIVE
K020499 · Jeneric/Pentron, Inc. · Apr 2002
ADPER PROMPT
K020946 · 3M Espe AG Dental Products · Apr 2002
TOUCH&BOND-PLUS
K020239 · Parkell, Inc. · Mar 2002
BOND-1 C & B
K013543 · Jeneric/Pentron, Inc. · Feb 2002