Cleared Traditional

K021427 - CLEARFIL SA PRIMER

K021427 is the FDA 510(k) clearance for CLEARFIL SA PRIMER by Kuraray Medical, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K021427 · Kuraray Medical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
35d
Days
Class 2
Risk

K021427 is an FDA 510(k) clearance for the CLEARFIL SA PRIMER. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Kuraray Medical, Inc. (New York, US). The FDA issued a Cleared decision on June 7, 2002 after a review of 35 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 Kuraray Medical, Inc. devices

Submission Details

510(k) Number K021427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2002
Decision Date June 07, 2002
Days to Decision 35 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
92d faster than avg
Panel avg: 127d · This submission: 35d
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 248
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K021427.
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
BOND-3 ADHESIVE
K020499 · Jeneric/Pentron, Inc. · Apr 2002
TOUCH&BOND-PLUS
K020239 · Parkell, Inc. · Mar 2002
BOND-1 C & B
K013543 · Jeneric/Pentron, Inc. · Feb 2002