Cleared Abbreviated

K002826 - EQUITY (FDA 510(k) Clearance)

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K002826 · Jensen Industries, Inc. · Dental device
Oct 2000
Decision
43d
Days
Class 2
Risk

K002826 is an FDA 510(k) clearance for the EQUITY. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Jensen Industries, Inc. (North Haven, US). The FDA issued a Cleared decision on October 24, 2000 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3060 - 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.

Submission Details

510(k) Number K002826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2000
Decision Date October 24, 2000
Days to Decision 43 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 158d · This submission: 43d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code EJT Alloy, Gold-based Noble Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3060
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.