Cleared Traditional

K930762 - SUPERSTAR

K930762 is an FDA 510(k) clearance for SUPERSTAR, 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 47-day FDA review.

K930762 · Jelenko Co. · Dental device
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Mar 1993
Decision
47d
Days
Class 2
Risk

K930762 is an FDA 510(k) clearance for the SUPERSTAR. 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 March 31, 1993 after a review of 47 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 - K930762

510(k) Number K930762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1993
Decision Date March 31, 1993
Days to Decision 47 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
80d faster than avg
Panel avg: 127d · This submission: 47d
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 K930762.
DENTAL CASTING ALLOY MODIFICATION-PF-4
K930481 · Deringer-Ney, Inc. · Mar 1993
DENTAL CASTING ALLOY, MODIFICATION - PF-3
K930482 · Deringer-Ney, Inc. · Mar 1993
FREEDOM
K930601 · J.F. Jelenko & Co., Inc. · Mar 1993
SYMPHONY
K923714 · J.F. Jelenko & Co., Inc. · Mar 1993
ULTRAGOLD
K923817 · J.F. Jelenko & Co., Inc. · Mar 1993
SUNCAST-D
K923715 · J.F. Jelenko & Co., Inc. · Mar 1993