Cleared Traditional

K011167 - XSE

K011167 is the FDA 510(k) clearance for XSE by 3M Company. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K011167 · 3M Company · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
31d
Days
Class 2
Risk

K011167 is an FDA 510(k) clearance for the XSE. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by 3M Company (St Paul, US). The FDA issued a Cleared decision on May 17, 2001 after a review of 31 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K011167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2001
Decision Date May 17, 2001
Days to Decision 31 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 127d · This submission: 31d
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 248
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K011167.
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
EXCITE DSC
K003293 · Ivoclar North America, Inc. · Feb 2001
SELF ETCH BONDING PRIMER
K003011 · Jeneric/Pentron, Inc. · Nov 2000
SOLOBOND PLUS
K003153 · Voco GmbH · Nov 2000