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EJJ — Alloy, Amalgam Class II

FDA Device Classification

FDA product code EJJ covers "Alloy, Amalgam", a Class II medical device regulated under 21 CFR 872.3070. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
EJJ
Device Class
Class II
Regulation Number
872.3070
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K053114dunia perwira manufacturing sdn. bhdSILVERFILNovember 15, 2005
K051010septodontSECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70May 2, 2005
K033434we dong myung dental industrial coBESTALOYNovember 12, 2003
K032152southern dental industriesBENCO ADMIXAugust 6, 2003
K031658southern dental industriesBENCO SPHERICALJuly 29, 2003
K020452ab ardentHIGH SILVER CONVENTIONALMay 7, 2002
K011801ab ardentFUTURA TOPCAP NON GAMMA-2August 16, 2001
K002808nordiska dentalANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOYOctober 31, 2000
K002810nordiska dentalANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOYOctober 31, 2000
K002811nordiska dentalANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOYOctober 31, 2000
K991481lancer orthodonticsPARAGONAugust 11, 1999
K982671specialites septodontSECURALLOYOctober 19, 1998
K982458ab ardentVIVALLOY HRAugust 24, 1998
K982460ab ardentVIVACAP HRAugust 24, 1998
K982456ab ardentAMALCAP PLUSAugust 24, 1998
K974035dentsply intlCENTURY ALLOYDecember 17, 1997
K973086southern dental industriesPLA-96POctober 7, 1997
K973088southern dental industriesPLS-96POctober 3, 1997
K964192ardent production developmentARDENT NON GAMMA-2 70January 6, 1997
K964775ardent production developmentARDENT FUTURA NON GAMMA-2December 10, 1996

FDA data resources