Cleared Traditional

K003293 - EXCITE DSC

K003293 is the FDA 510(k) clearance for EXCITE DSC by Ivoclar North America, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K003293 · Ivoclar North America, Inc. · Dental device
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Feb 2001
Decision
109d
Days
Class 2
Risk

K003293 is an FDA 510(k) clearance for the EXCITE DSC. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on February 6, 2001 after a review of 109 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 North America, Inc. devices

Submission Details

510(k) Number K003293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2000
Decision Date February 06, 2001
Days to Decision 109 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
18d faster than avg
Panel avg: 127d · This submission: 109d
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 282
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K003293.
OPTIBOND 2
K012322 · Sybron Dental Specialties, Inc. · Aug 2001
MODIFICATION TO EXCITE
K011490 · Ivoclar North America, Inc. · Jun 2001
XSE
K011167 · 3M Company · May 2001
SELF ETCH BONDING PRIMER
K003011 · Jeneric/Pentron, Inc. · Nov 2000
SOLOBOND PLUS
K003153 · Voco GmbH · Nov 2000
PQ1
K000189 · Ultradent Products, Inc. · May 2000