Medical Device Manufacturer · US , Attleboro , MA

Sterngold/Implamed - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 1992

Recent clearances: STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281, STERNVANTAGE VARNISH LC, MODEL 221001, STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION

16

Total

16

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sterngold/Implamed Dental ✕

15 devices

1-15 of 15

Cleared Jan 08, 1999

STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281

Cleared Jan 08, 1999

STERNVANTAGE VARNISH LC, MODEL 221001

Cleared Nov 13, 1998

STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND...

Cleared Oct 22, 1998

STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC

Cleared Oct 09, 1998

STERNOMEGA COMPOMER CEMENT

Cleared May 11, 1998

STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW...

Cleared Jul 24, 1996

STERNGOLD U-CPF METAL ALLOY (1067800)

Cleared Jul 24, 1996

QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015)

Cleared Jul 24, 1996

STERNGOLD BIO-5 (1127210)

Cleared Jul 23, 1996

STERNGOLD BIO-4

Cleared Jul 18, 1996

PEGASUS DENTAL ALLOY

Cleared Jul 18, 1996

Cleared May 29, 1996

STERNGOLD M-PF YELLOW CROWN & BRIDGE ALLOY MODEL 1127200

Cleared Mar 23, 1995

THE STERN ROOT ANCHOR SYSTEM

Cleared Jan 17, 1992

STERN ERA IMPLANT ABUTMENT