Cleared Traditional

K862822 - REXILLIUM N. B. F.
(FDA 510(k) Clearance)

K862822 · Jeneric Ind. · Dental
Sep 1986
Decision
39d
Days
Class 2
Risk

K862822 is an FDA 510(k) clearance for the REXILLIUM N. B. F., a Alloy, Metal, Base (Class II — Special Controls, product code EJH), submitted by Jeneric Ind. (Wallingford, US). The FDA issued a Cleared decision on September 2, 1986, 39 days after receiving the submission on July 25, 1986. This device falls under the Dental review panel. Regulated under 21 CFR 872.3710.

Submission Details

510(k) Number K862822 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 1986
Decision Date September 02, 1986
Days to Decision 39 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