Cleared Traditional

K150933 - iBond Universal & iBond Ceramic Primer

K150933 is an FDA 510(k) clearance for iBond Universal & iBond Ceramic Primer, manufactured by Heraeus Kulzer, LLC, Mitsui Chemicals Group. 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.

K150933 · Heraeus Kulzer, LLC, Mitsui Chemicals Group · Dental device
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Jul 2015
Decision
92d
Days
Class 2
Risk

K150933 is an FDA 510(k) clearance for the iBond Universal & iBond Ceramic Primer. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Heraeus Kulzer, LLC, Mitsui Chemicals Group (South Bend, US). The FDA issued a Cleared decision on July 7, 2015 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 Heraeus Kulzer, LLC, Mitsui Chemicals Group devices

FDA 510(k) Submission Details - K150933

510(k) Number K150933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2015
Decision Date July 07, 2015
Days to Decision 92 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
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 337
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K150933.
Prime&Bond Elect Universal Dental Adhesive
K151619 · Dentsply International, Inc. · Oct 2015
BRUSH&BOND PLUS
K151518 · Parkell, Inc. · Sep 2015
CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial)
K150703 · Kuraray Noritake Dental, Inc. · Aug 2015
G-Premio BOND
K143140 · GC America, Inc. · Apr 2015
Monobond Etch & Prime
K150164 · Ivoclar Vivadent, AG · Apr 2015
EAZY PRIMER
K142848 · Parkell, Inc. · Feb 2015