Cleared Traditional

K020050 - ENAMEL BONDING SYSTEM

K020050 is an FDA 510(k) clearance for ENAMEL BONDING SYSTEM, manufactured by Rite-Dent Manufacturing Corp.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K020050 · Rite-Dent Manufacturing Corp. · Dental device
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Feb 2002
Decision
38d
Days
Class 2
Risk

K020050 is an FDA 510(k) clearance for the ENAMEL BONDING SYSTEM. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Rite-Dent Manufacturing Corp. (Hialeah, US). The FDA issued a Cleared decision on February 14, 2002 after a review of 38 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 Rite-Dent Manufacturing Corp. devices

FDA 510(k) Submission Details - K020050

510(k) Number K020050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2002
Decision Date February 14, 2002
Days to Decision 38 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
89d faster than avg
Panel avg: 127d · This submission: 38d
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 370
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K020050.
OPTIBOND SOLO PLUS 4
K014027 · Kerr Dental Materials Center · 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
SIMPLE
K013519 · Bisco, Inc. · Jan 2002
OPTIBOND SOLO PLUS ACTIVATOR
K012082 · Sybron Dental Specialties, Inc. · Sep 2001