Cleared Traditional

K010415 - ISODAN

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

K010415 · Specialites Septodont · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K010415

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
Combination Product No
PCCP Authorized No
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.

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 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