Cleared Traditional

K010415 - ISODAN

K010415 is the FDA 510(k) clearance for ISODAN by Specialites Septodont. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K010415 · Specialites Septodont · Dental device
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Jul 2001
Decision
161d
Days
Class 2
Risk

K010415 is an FDA 510(k) clearance for the ISODAN. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Specialites Septodont (Washington, US). The FDA issued a Cleared decision on July 23, 2001 after a review of 161 days - an extended review 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: 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 Specialites Septodont devices

Submission Details

510(k) Number K010415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2001
Decision Date July 23, 2001
Days to Decision 161 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
34d slower than avg
Panel avg: 127d · This submission: 161d
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 283
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K010415.
MODIFICATION TO CLEARFIL PHOTO BOND
K012432 · Kuraray Medical, Inc. · Sep 2001
MODIFICATION TO ALLOY PRIMER
K012436 · Kuraray Medical, Inc. · Sep 2001
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
EXCITE DSC
K003293 · Ivoclar North America, Inc. · Feb 2001