Cleared Traditional

K053114 - SILVERFIL
(FDA 510(k) Clearance)

K053114 · Dunia Perwira Manufacturing Sdn. Bhd. · Dental
Nov 2005
Decision
8d
Days
Class 2
Risk

K053114 is an FDA 510(k) clearance for the SILVERFIL. This device is classified as a Alloy, Amalgam (Class II — Special Controls, product code EJJ).

Submitted by Dunia Perwira Manufacturing Sdn. Bhd. (Upm Serdang, Selangor, MY). The FDA issued a Cleared decision on November 15, 2005, 8 days after receiving the submission on November 7, 2005.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3070.

Submission Details

510(k) Number K053114 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 2005
Decision Date November 15, 2005
Days to Decision 8 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJJ — Alloy, Amalgam
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3070