Cleared Traditional

K964158 - JEL-40 (CODE NAME RD-0430)

K964158 is an FDA 510(k) clearance for JEL-40 (CODE NAME RD-0430), manufactured by Jelenko Co.. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K964158 · Jelenko Co. · Dental device
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Dec 1996
Decision
58d
Days
Class 2
Risk

K964158 is an FDA 510(k) clearance for the JEL-40 (CODE NAME RD-0430). Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Jelenko Co. (Armonk, US). The FDA issued a Cleared decision on December 13, 1996 after a review of 58 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 Jelenko Co. devices

FDA 510(k) Submission Details - K964158

510(k) Number K964158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1996
Decision Date December 13, 1996
Days to Decision 58 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
69d faster than avg
Panel avg: 127d · This submission: 58d
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 549
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K964158.
PACIFIC 56 (CB-40)
K964837 · Gateway Alloys, Inc. · Dec 1996
PALLADIA 85 (PM-13)
K964838 · Gateway Alloys, Inc. · Dec 1996
SOLDER 615
K964708 · Gateway Alloys, Inc. · Dec 1996
OZARK 20
K964566 · Gateway Alloys, Inc. · Dec 1996
EL DORADO 75
K964567 · Gateway Alloys, Inc. · Dec 1996
OZARK 46
K964568 · Gateway Alloys, Inc. · Dec 1996