Cleared Traditional

K840562 - REX V
(FDA 510(k) Clearance)

K840562 · Jeneric Ind. · Dental device

Apr 1984

Decision

65d

Days

Class 2

Risk

K840562 is an FDA 510(k) clearance for the REX V. This device is classified as a Alloy, Metal, Base (Class II - Special Controls, product code EJH).

Submitted by Jeneric Ind. (Mchenry, US). The FDA issued a Cleared decision on April 13, 1984, 65 days after receiving the submission on February 8, 1984.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3710.

Submission Details

510(k) Number	K840562 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 08, 1984
Decision Date	April 13, 1984
Days to Decision	65 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—