Cleared Traditional

K090941 - ADHESE ONE F

K090941 is the FDA 510(k) clearance for ADHESE ONE F by Ivoclar Vivadent, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K090941 · Ivoclar Vivadent, Inc. · Dental device
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Jul 2009
Decision
105d
Days
Class 2
Risk

K090941 is an FDA 510(k) clearance for the ADHESE ONE F. 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 July 17, 2009 after a review of 105 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 Ivoclar Vivadent, Inc. devices

Submission Details

510(k) Number K090941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2009
Decision Date July 17, 2009
Days to Decision 105 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
22d faster than avg
Panel avg: 127d · This submission: 105d
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 248
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K090941.
PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)
K100752 · Ultradent Products, Inc. · Jul 2010
EXCITE F AND EXCITE DSC
K093744 · Ivoclar Vivadent, Inc. · Mar 2010
PRIMER PLUS
K091705 · Bisco, Inc. · Aug 2009
MONOBOND PLUS
K090826 · Ivoclar Vivadent, Inc. · May 2009
BEAUTIBOND
K082744 · Shofu Dental Corp. · Dec 2008
FUTURABOND M/FUTURABOND M SINGLE DOSE
K082753 · Voco GmbH · Nov 2008