Cleared Traditional

K003293 - EXCITE DSC

K003293 is an FDA 510(k) clearance for EXCITE DSC, manufactured by Ivoclar North America, Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K003293

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.

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 380
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K003293.
ISODAN
K010415 · Specialites Septodont · Jul 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
CERAM-PRIME
K002502 · S & C Polymer GmbH · Nov 2000