Cleared Traditional

K962303 - STERNGOLD CF

K962303 is an FDA 510(k) clearance for STERNGOLD CF, manufactured by Sterngold/Implamed. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K962303 · Sterngold/Implamed · Dental device
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Jul 1996
Decision
31d
Days
Class 2
Risk

K962303 is an FDA 510(k) clearance for the STERNGOLD CF. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Sterngold/Implamed (Sunrise, US). The FDA issued a Cleared decision on July 18, 1996 after a review of 31 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 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 Sterngold/Implamed devices

FDA 510(k) Submission Details - K962303

510(k) Number K962303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1996
Decision Date July 18, 1996
Days to Decision 31 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 127d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJT Device Classification - Class 2, Special Controls

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.

Regulatory Peers - EJT Alloy, Gold-based Noble Metal

All 551
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K962303.
QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015)
K962325 · Sterngold/Implamed · Jul 1996
STERNGOLD BIO-5 (1127210)
K962326 · Sterngold/Implamed · Jul 1996
PEGASUS DENTAL ALLOY
K962302 · Sterngold/Implamed · Jul 1996
STERNGOLD M-PF YELLOW CROWN & BRIDGE ALLOY MODEL 1127200
K960956 · Sterngold/Implamed · May 1996
285 SL
K961352 · Argen Precious Metals, Inc. · May 1996
ARGELITE 52+
K961211 · Argen Precious Metals, Inc. · Apr 1996