Cleared Traditional

K151526 - Zone, ZoneFree, Zone A1 (FDA 510(k) Clearance)

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

K151526 · Sybron Dental Specialties · Dental device
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.

Submission Details

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
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 158d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 18
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K151526.
Bifix Veneer LC, Bifix Veneer Try-In
K252606 · Voco GmbH · Mar 2026
iCEM Universal Plus
K254063 · Kulzer, LLC · Dec 2025
TopCEM Vigor SA Self-Adhesive Resin Cement
K252785 · Rizhao Huge Biomaterials Company, Ltd. · Dec 2025
GlasIonomer FX-LC
K252808 · Shofu Dental Corporation · Dec 2025
ZIRCONOMER P
K252165 · Shofu Dental Corporation · Oct 2025
EQUIA LC ONE
K250953 · GC America, Inc. · Sep 2025