Sterngold/Implamed

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K984341STERNVANTAGE VARNISH LC, MODEL 221001January 8, 1999
K984340STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281January 8, 1999
K983786STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATIONNovember 13, 1998
K982692STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LCOctober 22, 1998
K982895STERNOMEGA COMPOMER CEMENTOctober 9, 1998
K981516STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFMay 11, 1998
K962326STERNGOLD BIO-5 (1127210)July 24, 1996
K962325QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015)July 24, 1996
K962324STERNGOLD U-CPF METAL ALLOY (1067800)July 24, 1996
K962304STERNGOLD BIO-4July 23, 1996
K962302PEGASUS DENTAL ALLOYJuly 18, 1996
K962303STERNGOLD CFJuly 18, 1996
K960956STERNGOLD M-PF YELLOW CROWN & BRIDGE ALLOY MODEL 1127200May 29, 1996
K950213THE STERN ROOT ANCHOR SYSTEMMarch 23, 1995
K913348THE STERN ERA SYSTEMJanuary 30, 1992
K914764STERN ERA IMPLANT ABUTMENTJanuary 17, 1992