Cleared Traditional

RX CBY

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

About This 510(k) Submission

K844123 is an FDA 510(k) clearance for the RX CBY, a Alloy, Metal, Base (Class II — Special Controls, product code EJH), submitted by Jeneric Ind. (Wallingford, US). The FDA issued a Cleared decision on January 9, 1985, 78 days after receiving the submission on October 23, 1984. This device falls under the Dental review panel. Regulated under 21 CFR 872.3710.

Submission Details

510(k) Number K844123 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 1984
Decision Date January 09, 1985
Days to Decision 78 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EJH — Alloy, Metal, Base
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3710