Cleared Traditional

DELTAPAL, ALLOY NO. 5161

K993474 · Metalor Dental USA Corp. · Dental
Dec 1999
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K993474 is an FDA 510(k) clearance for the DELTAPAL, ALLOY NO. 5161, a Alloy, Other Noble Metal (Class II — Special Controls, product code EJS), submitted by Metalor Dental USA Corp. (North Attleborough, US). The FDA issued a Cleared decision on December 2, 1999, 49 days after receiving the submission on October 14, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K993474 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 1999
Decision Date December 02, 1999
Days to Decision 49 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJS — Alloy, Other Noble Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3060