Cleared Abbreviated

K151332 - Nexus Universal, Nexus Universal Chroma

K151332 is an FDA 510(k) clearance for Nexus Universal, manufactured by Sybron Dental Specialties. The device is a Class 2 Dental device with product code EMA cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K151332 · Sybron Dental Specialties · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
90d
Days
Class 2
Risk

K151332 is an FDA 510(k) clearance for the Nexus Universal, Nexus Universal Chroma. 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 August 17, 2015 after a review of 90 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Sybron Dental Specialties devices

FDA 510(k) Submission Details - K151332

510(k) Number K151332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2015
Decision Date August 17, 2015
Days to Decision 90 days
Submission Type Abbreviated
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
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

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 K151332.
EDS Universal Cement
K152691 · Essential Dental Systems, Inc. · Feb 2016
Zone, ZoneFree, Zone A1
K151526 · Sybron Dental Specialties · Sep 2015
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
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ESTECEM
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K142446 · Exacta Dental Direct, Inc. · Jun 2015