Cleared Traditional

K844123 - RX CBY

K844123 is an FDA 510(k) clearance for RX CBY, manufactured by Jeneric Ind.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K844123 · Jeneric Ind. · Dental device
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Jan 1985
Decision
78d
Days
Class 2
Risk

K844123 is an FDA 510(k) clearance for the RX CBY. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Jeneric Ind. (Wallingford, US). The FDA issued a Cleared decision on January 9, 1985 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3710 - 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 - K844123

510(k) Number K844123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1984
Decision Date January 09, 1985
Days to Decision 78 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
49d faster than avg
Panel avg: 127d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJH Device Classification - Class 2, Special Controls

Product Code EJH Alloy, Metal, Base
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3710
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 - EJH Alloy, Metal, Base

All 79
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K844123.
CERAMIC ALLOY NO. DW 179
K852895 · Williams Gold Refining Co., Inc. · Oct 1985
VERA BOND NON PERCIOUS CERAMIC ALLOY
K851569 · Aalba Dent, Inc. · May 1985
RX CBG
K844122 · Jeneric Ind. · Jan 1985
BASE METAL ALLOY
K842551 · Dentsply Intl. · Aug 1984
REX V
K840562 · Jeneric Ind. · Apr 1984
VITEX P.D.A
K834560 · Jeneric Ind. · Feb 1984