Cleared Traditional

K912194 - PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE

K912194 is an FDA 510(k) clearance for PA-393 GOLD BASED/PRECIOUS METAL ALLOYS..., manufactured by Jelenko Co.. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K912194 · Jelenko Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1991
Decision
74d
Days
Class 2
Risk

K912194 is an FDA 510(k) clearance for the PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Jelenko Co. (Armonk, US). The FDA issued a Cleared decision on July 30, 1991 after a review of 74 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 - K912194

510(k) Number K912194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1991
Decision Date July 30, 1991
Days to Decision 74 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
53d faster than avg
Panel avg: 127d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJS Device Classification - Class 2, Special Controls

Product Code EJS Alloy, Other 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 - EJS Alloy, Other Noble Metal

All 171
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K912194.
STANDARD S3
K912305 · Metalor Dental USA Corp. · Aug 1991
STANDARD S31
K912307 · Metalor Dental USA Corp. · Aug 1991
STANDARD S32
K912308 · Metalor Dental USA Corp. · Aug 1991
CERADELTA
K911671 · Metalor Dental USA Corp. · Jul 1991
V-DELTA
K911545 · Metalor Dental USA Corp. · Jul 1991
800 SOLDER
K912314 · Metalor Dental USA Corp. · Jul 1991