Cleared Traditional

MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA

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

About This 510(k) Submission

K252469 is an FDA 510(k) clearance for the MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Dmp Dental Industry S.A. (Markopoulo, GR). The FDA issued a Cleared decision on November 6, 2025, 92 days after receiving the submission on August 6, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K252469 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200