Cleared Traditional

K252450 - Adhese 2 (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K252450 is an FDA 510(k) clearance for the Adhese 2. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on March 5, 2026 after a review of 213 days - an extended review 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: 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 Ivoclar Vivadent, Inc. devices

Submission Details

510(k) Number K252450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 127d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 417
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K252450.
Porcelain Etch Gel
K260430 · Belport Company, Inc., Gingi-Pak · Apr 2026
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K260682 · Premier Dental Products Company · Mar 2026
VITA VMLC Primer
K251587 · Vita Zahnfabrik H. Rauter GmbH & Co. Kg. · Feb 2026
els unibond
K252151 · Saremco Dental AG · Dec 2025
MAGNABOND SE
K252469 · Dmp Dental Industry S.A. · Nov 2025
G-Bond Universal
K251124 · GC America, Inc. · Oct 2025