Cleared Traditional

K252469 - MAGNABOND SE

Also marketed or referenced as:
MAGNABOND UNIVERSAL MAGNABOND UNIVERSAL DCA

K252469 is an FDA 510(k) clearance for MAGNABOND SE, manufactured by Dmp Dental Industry S.A.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K252469 · Dmp Dental Industry S.A. · Dental device
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Nov 2025
Decision
92d
Days
Class 2
Risk

K252469 is an FDA 510(k) clearance for the MAGNABOND SE. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Dmp Dental Industry S.A. (Markopoulo, GR). The FDA issued a Cleared decision on November 6, 2025 after a review of 92 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.

View all Dmp Dental Industry S.A. devices

FDA 510(k) Submission Details - K252469

510(k) Number K252469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2025
Decision Date November 06, 2025
Days to Decision 92 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
35d faster than avg
Panel avg: 127d · This submission: 92d
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 317
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K252469.
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K242749 · Rizhao Huge Biomaterials Company, Ltd. · Nov 2024