Cleared Traditional

K062519 - NEXUS 3

K062519 is an FDA 510(k) clearance for NEXUS 3, 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 52-day FDA review.

K062519 · Kerr Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
52d
Days
Class 2
Risk

K062519 is an FDA 510(k) clearance for the NEXUS 3. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Kerr Corporation (Newport Beach, US). The FDA issued a Cleared decision on October 19, 2006 after a review of 52 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kerr Corporation devices

FDA 510(k) Submission Details - K062519

510(k) Number K062519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2006
Decision Date October 19, 2006
Days to Decision 52 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
75d faster than avg
Panel avg: 127d · This submission: 52d
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
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