Cleared Traditional

K960399 - TOPAZ

K960399 is the FDA 510(k) clearance for TOPAZ by J.F. Jelenko & Co., Inc.. It is a Class 2 Dental device (product code EJT) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K960399 · J.F. Jelenko & Co., Inc. · Dental device
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Optimized for regulatory review, auditing and printing
Feb 1996
Decision
23d
Days
Class 2
Risk

K960399 is an FDA 510(k) clearance for the TOPAZ. 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 21, 1996 after a review of 23 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 J.F. Jelenko & Co., Inc. devices

Submission Details

510(k) Number K960399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1996
Decision Date February 21, 1996
Days to Decision 23 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
104d faster than avg
Panel avg: 127d · This submission: 23d
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 435
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K960399.
ARGELITE 52+
K961211 · Argen Precious Metals, Inc. · Apr 1996
ARGEDENT 40(GOLD-PALLADIUM-SILVER ALLOY FOR PORCELAIN APPLICATION)
K961285 · Argen Precious Metals, Inc. · Apr 1996
DIAMOND (CODE NAME PT-054)
K960403 · J.F. Jelenko & Co., Inc. · Feb 1996
DW260 19
K954837 · Ivoclar North America, Inc. · Nov 1995
IMPLANTALOY
K954702 · Metalor Dental USA Corp. · Oct 1995
ARGISTAR 74
K954362 · Argen Precious Metals, Inc. · Oct 1995