Silverfil

FDA 510(k) K053114 · Dunia Perwira Manufacturing Sdn. Bhd.

Substantially Equivalent

510(k) numberK053114

Submission

Device name
Silverfil
Applicant
Dunia Perwira Manufacturing Sdn. Bhd.
Upm Serdang, Selangor, MY
Received
November 7, 2005
Decision date
November 15, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
EJJ – Alloy, Amalgam
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3070
Specialty
Dental

Other 510(k)s with product code EJJ

510(k)DeviceApplicantDecision
K051010Securalloy, Septalloy NG 50 and Septalloy NG 70EJJ · Special Septodont05/02/2005SE
K033434BestaloyEJJ · Traditional We Dong Myung Dental Industrial Co., Ltd.11/12/2003SE
K032152Benco AdmixEJJ · Traditional Southern Dental Industries, Inc.08/06/2003SE
K031658Benco SphericalEJJ · Traditional Southern Dental Industries, Inc.07/29/2003SE
K020452High Silver ConventionalEJJ · Traditional Ab Ardent05/07/2002SE
K011801Futura Topcap Non GAMMA-2EJJ · Traditional Ab Ardent08/16/2001SE
K002811Ana 70 Non Gamma 2 Dispersed Phase Dental AlloyEJJ · Traditional Nordiska Dental AB10/31/2000SE
K002810Ana 3000 SM Non Gamma 2 Modified Spherical Dental AlloyEJJ · Traditional Nordiska Dental AB10/31/2000SE
K002808Ana 2000 Non Gamma 2 Extra High Copper Dental AlloyEJJ · Traditional Nordiska Dental AB10/31/2000SE
K991481ParagonEJJ · Traditional Lancer Orthodontics, Inc.08/11/1999SE

Questions and answers

When was Silverfil cleared by the FDA?

Silverfil (K053114) received a 510(k) decision of Substantially Equivalent on November 15, 2005, 8 days after the submission was received.

What is the product code of K053114?

The FDA product code is EJJ – Alloy, Amalgam, a Class II (moderate risk) device regulated under 21 CFR 872.3070.