Cleared Traditional

K151526 - Zone, ZoneFree, Zone A1

K151526 is an FDA 510(k) clearance for Zone, manufactured by Sybron Dental Specialties. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K151526 · Sybron Dental Specialties · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
94d
Days
Class 2
Risk

K151526 is an FDA 510(k) clearance for the Zone, ZoneFree, Zone A1. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Sybron Dental Specialties (Orange, US). The FDA issued a Cleared decision on September 10, 2015 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 Sybron Dental Specialties devices

FDA 510(k) Submission Details - K151526

510(k) Number K151526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2015
Decision Date September 10, 2015
Days to Decision 94 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
33d faster than avg
Panel avg: 127d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 421
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K151526.
Ketac Universal Aplicap
K153174 · 3M Deutschland GmbH · Apr 2016
PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement
K152652 · Gaia Dental Products, Inc. · Apr 2016
EDS Universal Cement
K152691 · Essential Dental Systems, Inc. · Feb 2016
PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer
K150704 · Kuraray Noritake Dental, Inc. · Aug 2015
Nexus Universal, Nexus Universal Chroma
K151332 · Sybron Dental Specialties · Aug 2015
Zeramic Adhesive Resin Cement
K150601 · Premier Dental Company Products · Jul 2015