Cleared Traditional

K013584 - EXCITE SELF ETCH

K013584 is an FDA 510(k) clearance for EXCITE SELF ETCH, manufactured by Ivoclar Vivadent, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K013584 · Ivoclar Vivadent, Inc. · Dental device
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Jan 2002
Decision
90d
Days
Class 2
Risk

K013584 is an FDA 510(k) clearance for the EXCITE SELF ETCH. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on January 28, 2002 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ivoclar Vivadent, Inc. devices

FDA 510(k) Submission Details - K013584

510(k) Number K013584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2001
Decision Date January 28, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
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 374
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K013584.
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
SIMPLE
K013519 · Bisco, Inc. · Jan 2002
OPTIBOND SOLO PLUS ACTIVATOR
K012082 · Sybron Dental Specialties, Inc. · Sep 2001
CLEARFIL NEW BOND
K012734 · Kuraray Medical, Inc. · Sep 2001