Cleared Traditional

K893688 - HIGH NOBLE, TYPE III DENTAL CASTING ALLOY

K893688 is an FDA 510(k) clearance for HIGH NOBLE, 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 99-day FDA review.

K893688 · Jelenko Co. · Dental device
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Aug 1989
Decision
99d
Days
Class 2
Risk

K893688 is an FDA 510(k) clearance for the HIGH NOBLE, TYPE III DENTAL CASTING ALLOY. 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 August 23, 1989 after a review of 99 days - within the typical 510(k) review window.

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 Jelenko Co. devices

FDA 510(k) Submission Details - K893688

510(k) Number K893688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1989
Decision Date August 23, 1989
Days to Decision 99 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 127d · This submission: 99d
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 K893688.
MONOGRAM II
K895064 · Leach and Dillon Co., Inc. · Dec 1989
MONOGRAM III
K895065 · Leach and Dillon Co., Inc. · Dec 1989
SELECT 50
K895068 · Leach and Dillon Co., Inc. · Dec 1989
ARGENCO 50 TYPE IV TYPE IV DENTAL GOLD ALLOY
K893566 · Argen Precious Metals, Inc. · Jul 1989
ARGENCO 68 TYPE IV DENTAL GOLD ALLOY
K893565 · Argen Precious Metals, Inc. · Jun 1989
ARGENCO 56 TYPE IV DENTAL GOLD ALLOY
K893568 · Argen Precious Metals, Inc. · Jun 1989