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510(k) K053114

Device
SILVERFIL
Applicant
Dunia Perwira Manufacturing Sdn. Bhd.
510(k) number
K053114
Product code
EJJ
Decision
Substantially Equivalent (SESE)
Decision date
2005-11-15
Date received
2005-11-07
Regulation
872.3070
Classification name
Alloy, Amalgam
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
Y

Applicant Contact#

Contact
NARESH SANCHANA
Address
Block G, Upm-Mtdc Technology Center One, Lebuh Silikon Upm Serdang, Selangor MY 43400 43400

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EJJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K051010SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70Septodont2005-05-02
K033434BESTALOYWe Dong Myung Dental Industrial Co., Ltd.2003-11-12
K032152BENCO ADMIXSouthern Dental Industries, Inc.2003-08-06
K031658BENCO SPHERICALSouthern Dental Industries, Inc.2003-07-29
K020452HIGH SILVER CONVENTIONALAb Ardent2002-05-07
K011801FUTURA TOPCAP NON GAMMA-2Ab Ardent2001-08-16
K002810ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOYNordiska Dental AB2000-10-31
K002808ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOYNordiska Dental AB2000-10-31
K002811ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOYNordiska Dental AB2000-10-31
K991481PARAGONLancer Orthodontics, Inc.1999-08-11
K982671SECURALLOYSpecialites Septodont1998-10-19
K982460VIVACAP HRAb Ardent1998-08-24
K982458VIVALLOY HRAb Ardent1998-08-24
K982456AMALCAP PLUSAb Ardent1998-08-24
K974035CENTURY ALLOYDentsply Intl.1997-12-17