Cleared Traditional

K262252 - MPa Max adhesive

K262252 is an FDA 510(k) clearance for MPa Max adhesive, manufactured by Den-Mat Holdings, LLC. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K262252 · Den-Mat Holdings, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
84d
Days
Class 2
Risk

K262252 is an FDA 510(k) clearance for the MPa Max adhesive. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Den-Mat Holdings, LLC (Lompoc, US). The FDA issued a Cleared decision on September 24, 2026 after a review of 84 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.

View all Den-Mat Holdings, LLC devices

FDA 510(k) Submission Details - K262252

510(k) Number K262252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2026
Decision Date September 24, 2026
Days to Decision 84 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
44d faster than avg
Panel avg: 128d · This submission: 84d
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 389
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K262252.
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K252151 · Saremco Dental AG · Dec 2025