Cleared Traditional

K840561 - RX ELAN

K840561 is an FDA 510(k) clearance for RX ELAN, manufactured by Jeneric Ind.. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K840561 · Jeneric Ind. · Dental device
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May 1984
Decision
83d
Days
Class 2
Risk

K840561 is an FDA 510(k) clearance for the RX ELAN. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Jeneric Ind. (Mchenry, US). The FDA issued a Cleared decision on May 1, 1984 after a review of 83 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 Jeneric Ind. devices

FDA 510(k) Submission Details - K840561

510(k) Number K840561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1984
Decision Date May 01, 1984
Days to Decision 83 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 127d · This submission: 83d
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 156
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K840561.
GDC-1433 A CASTING ALLOY
K850102 · Deringer-Ney, Inc. · Feb 1985
GDC-1489 A CASTING ALLOY
K850103 · Deringer-Ney, Inc. · Feb 1985
PORS-ON HF-SOLDER(PORCELAIN DENTAL ALLOYS)
K850193 · Degussa Dental, Inc. · Feb 1985
RX C & B 20
K840563 · Jeneric Ind. · May 1984
NATURELLE II & LITE II-N72-N74-L
K833774 · Jeneric Ind. · Jan 1984
CERAMCO * HIGH FUSING FOIL SOLDER
K833434 · Johnson & Johnson Professionals, Inc. · Dec 1983