Cleared Traditional

GOLD/PALLADIUM BASED DENTAL ALLOY (K885302) - FDA 510(k) Clearance

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

K885302 · Jelenko Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1989
Decision
48d
Days
Class 2
Risk

K885302 is an FDA 510(k) clearance for the GOLD/PALLADIUM BASED DENTAL 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 February 13, 1989 after a review of 48 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

Submission Details

510(k) Number K885302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1988
Decision Date February 13, 1989
Days to Decision 48 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 127d · This submission: 48d
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 K885302.
ARGIPAL
K893011 · Argen Precious Metals, Inc. · May 1989
ARGEDENT 75
K892234 · Argen Precious Metals, Inc. · May 1989
ARGEDENT 52SF
K891911 · Argen Precious Metals, Inc. · May 1989
HOWMEDICA A-30 DENTAL ALLOY
K791304 · Howmedica Corp. · Oct 1979
A-33 DENTAL ALLOY
K781045 · Howmedica Corp. · Jul 1978
HERITAGE SPECIAL ALLOY
K771110 · Howmedica Corp. · Jul 1977