Cleared Traditional

K110302 - ADHESIVE EXL-759

K110302 is an FDA 510(k) clearance for ADHESIVE EXL-759, manufactured by 3M Espe AG. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K110302 · 3M Espe AG · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
106d
Days
Class 2
Risk

K110302 is an FDA 510(k) clearance for the ADHESIVE EXL-759. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by 3M Espe AG (Bavaria D-82228 Seefeld, DE). The FDA issued a Cleared decision on May 19, 2011 after a review of 106 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.

FDA 510(k) Submission Details - K110302

510(k) Number K110302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2011
Decision Date May 19, 2011
Days to Decision 106 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
22d faster than avg
Panel avg: 128d · This submission: 106d
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 402
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K110302.
Z BOND, PRELUDE ONE
K111876 · Danville Materials, Inc. · Sep 2011
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K110403 · Silmet , Ltd. · Sep 2011
B1P ADHESIVE
K111431 · Pentron Clinical · Aug 2011
BEAUTIBOND MULTI
K110235 · Shofu Dental Corp. · May 2011
BEAUTIBOND MULTI PR PLUS
K110252 · Shofu Dental Corp. · May 2011
DMP SINGLE BONDING
K102254 · Dmp, Ltd. · Nov 2010