Cleared Traditional

H40 BASE METAL ALLOY

K854878 · Jeneric Ind. · Dental
Jan 1986
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K854878 is an FDA 510(k) clearance for the H40 BASE METAL ALLOY, 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 30, 1986, 55 days after receiving the submission on December 6, 1985. This device falls under the Dental review panel. Regulated under 21 CFR 872.3710.

Submission Details

510(k) Number K854878 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 1985
Decision Date January 30, 1986
Days to Decision 55 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