Cleared Traditional

K152243 - One Coat 7 Universal

K152243 is an FDA 510(k) clearance for One Coat 7 Universal, manufactured by Coltene/Whaledent AG. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K152243 · Coltene/Whaledent AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
121d
Days
Class 2
Risk

K152243 is an FDA 510(k) clearance for the One Coat 7 Universal. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Coltene/Whaledent AG (Altstatten, CH). The FDA issued a Cleared decision on December 9, 2015 after a review of 121 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 Coltene/Whaledent AG devices

FDA 510(k) Submission Details - K152243

510(k) Number K152243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2015
Decision Date December 09, 2015
Days to Decision 121 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
6d faster than avg
Panel avg: 127d · This submission: 121d
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 372
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K152243.
HC Primer
K161891 · Shofu Dental Corporation · Nov 2016
CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack
K161042 · Kuraray Noritake Dental, Inc. · Oct 2016
All-Bond Universal w/BAC (not finalized)
K161051 · Bisco, Inc. · Sep 2016
e-1 etchants
K152110 · E Dental Products · Nov 2015
Prime&Bond Elect Universal Dental Adhesive
K151619 · Dentsply International, Inc. · Oct 2015
BRUSH&BOND PLUS
K151518 · Parkell, Inc. · Sep 2015