Cleared Traditional

K874308 - JEL-62

K874308 is an FDA 510(k) clearance for JEL-62, 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 150-day FDA review.

K874308 · Jelenko Co. · Dental device
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Optimized for regulatory review, auditing and printing
Mar 1988
Decision
150d
Days
Class 2
Risk

K874308 is an FDA 510(k) clearance for the JEL-62. 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 18, 1988 after a review of 150 days - an extended review 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: 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 - K874308

510(k) Number K874308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1987
Decision Date March 18, 1988
Days to Decision 150 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 127d · This submission: 150d
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 K874308.
PTM-45
K881861 · J.F. Jelenko & Co., Inc. · Jun 1988
PALLADIUM-BASED DENTAL ALLOYS FOR PORCELAIN APPLI.
K880348 · J.F. Jelenko & Co., Inc. · May 1988
RAJAH
K881354 · J.F. Jelenko & Co., Inc. · Apr 1988
DEGUSTAR
K880033 · Degussa Dental, Inc. · Mar 1988
NEY-ORO 41
K870677 · Deringer-Ney, Inc. · May 1987
PONTALLOR 4 DENTAL ALLOY
K870024 · Degussa Dental, Inc. · Mar 1987