Cleared Traditional

EUREKA (K933623) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K933623 · J.F. Jelenko & Co., Inc. · Dental device
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Feb 1994
Decision
197d
Days
Class 2
Risk

K933623 is an FDA 510(k) clearance for the EUREKA. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by J.F. Jelenko & Co., Inc. (Armonk, US). The FDA issued a Cleared decision on February 1, 1994 after a review of 197 days - an extended review 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: 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 J.F. Jelenko & Co., Inc. devices

Submission Details

510(k) Number K933623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1993
Decision Date February 01, 1994
Days to Decision 197 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 127d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - EJT Alloy, Gold-based Noble Metal

All 208
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K933623.
ARGEDENT 51SF
K940281 · Argen Precious Metals, Inc. · Mar 1994
AURIUM J
K940278 · Argen Precious Metals, Inc. · Feb 1994
AURIUM 224
K940111 · Argen Precious Metals, Inc. · Feb 1994
ARGISTAR 72 (HIGH GOLD PLATINUM SILVER ALLOY FOR BOTH LOW FUSING PORCELAIN AND CROWN AND BRIDGE APPLICATION
K935973 · Argen Precious Metals, Inc. · Jan 1994
ARGEDENT 77PF
K935507 · Argen Precious Metals, Inc. · Jan 1994
ARGEDENT 78PF
K935508 · Argen Precious Metals, Inc. · Jan 1994