Cleared Traditional

K123595 - NEXUS RMGI

K123595 is an FDA 510(k) clearance for NEXUS RMGI, manufactured by Kerr Corporation. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K123595 · Kerr Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
90d
Days
Class 2
Risk

K123595 is an FDA 510(k) clearance for the NEXUS RMGI. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Kerr Corporation (Orange, US). The FDA issued a Cleared decision on February 19, 2013 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 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 Kerr Corporation devices

FDA 510(k) Submission Details - K123595

510(k) Number K123595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2012
Decision Date February 19, 2013
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 K123595.
PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM
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VITRO MOLAR
K123826 · Dfl Industria E Comercio SA · Feb 2013
SOLOCEM
K121621 · Coltene/Whaledent AG · Jan 2013
RMGI LOW VISCOSITY
K123265 · Pulpdent Corporation · Dec 2012