Cleared Traditional

Adhese 2

K252450 · Ivoclar Vivadent, Inc. · Dental
Mar 2026
Decision
213d
Days
Class 2
Risk

About This 510(k) Submission

K252450 is an FDA 510(k) clearance for the Adhese 2, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on March 5, 2026, 213 days after receiving the submission on August 4, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K252450 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2025
Decision Date March 05, 2026
Days to Decision 213 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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

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