Cleared Traditional

K014027 - OPTIBOND SOLO PLUS 4

K014027 is an FDA 510(k) clearance for OPTIBOND SOLO PLUS 4, 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 78-day FDA review.

K014027 · Kerr Dental Materials Center · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
78d
Days
Class 2
Risk

K014027 is an FDA 510(k) clearance for the OPTIBOND SOLO PLUS 4. 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 February 22, 2002 after a review of 78 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 - K014027

510(k) Number K014027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2001
Decision Date February 22, 2002
Days to Decision 78 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
49d faster than avg
Panel avg: 127d · This submission: 78d
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 K014027.
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
UNIFIL BOND
K013997 · GC America, Inc. · Feb 2002
DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)
K013542 · Jeneric/Pentron, Inc. · Feb 2002
EXCITE SELF ETCH
K013584 · Ivoclar Vivadent, Inc. · Jan 2002