Cleared Abbreviated

K022252 - STERNGOLD 1, MODEL 1127781

K022252 is an FDA 510(k) clearance for STERNGOLD 1, manufactured by Sterngold. The device is a Class 2 Dental device with product code EJS cleared through the Abbreviated 510(k) pathway after a 69-day FDA review.

K022252 · Sterngold · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
69d
Days
Class 2
Risk

K022252 is an FDA 510(k) clearance for the STERNGOLD 1, MODEL 1127781. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Sterngold (Attleboro, US). The FDA issued a Cleared decision on September 19, 2002 after a review of 69 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.

View all Sterngold devices

FDA 510(k) Submission Details - K022252

510(k) Number K022252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2002
Decision Date September 19, 2002
Days to Decision 69 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 127d · This submission: 69d
Pathway characteristics
Standards-based clearance path.

EJS Device Classification - Class 2, Special Controls

Product Code EJS Alloy, Other 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.

Regulatory Peers - EJS Alloy, Other Noble Metal

All 169
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K022252.
BRIGHT GOLD XH
K041433 · Ivoclar Vivadent, Inc. · Aug 2004
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K022469 · Wieland Dental + Technik GmbH & Co. KG · Sep 2002
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SIMIDUR KF PLUS
K020194 · Wieland Dental + Technik GmbH & Co. KG · Mar 2002
SIMIDUR S1S
K020195 · Wieland Dental + Technik GmbH & Co. KG · Mar 2002