Medical Device Manufacturer · US , Sunrise , FL

Sterngold

12 submissions · 12 cleared · Since 1995
12
Total
12
Cleared
0
Denied

Sterngold — FDA 510(k) Submissions

Sterngold has submitted 12 FDA 510(k) premarket notifications since 1995, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Implant, Endosseous, Root-form, Alloy, Gold-based Noble Metal, Alloy, Other Noble Metal . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM
K092434 · DZE Implant, Endosseous,... · Dental
Nov 2009 95d
STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM
K041271 · DZE Implant, Endosseous,... · Dental
Oct 2004 169d
STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM
K023580 · DZE Implant, Endosseous,... · Dental
Jan 2003 85d
STERNGOLD 1, MODEL 1127781
K022252 · EJS Alloy, Other Noble Metal · Dental
Sep 2002 69d
ERA IMPLANT
K021045 · DZE Implant, Endosseous,... · Dental
Jun 2002 86d
CRITERTION, MODEL #1067511
K021741 · EJT Alloy, Gold-based Noble... · Dental
Jun 2002 29d
STERNGOLD 66, MODEL #1180230
K021367 · EJS Alloy, Other Noble Metal · Dental
May 2002 16d
APOLLO, MODEL 1124525
K020949 · EJT Alloy, Gold-based Noble... · Dental
Apr 2002 10d
STERN MICRO ERA ATTACHMENT SYSTEM
K020391 · DZE Implant, Endosseous,... · Dental
Mar 2002 30d
GALAXY
K003007 · EJT Alloy, Gold-based Noble... · Dental
Nov 2000 52d
STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTRUMENTATION
K991436 · DZE Implant, Endosseous,... · Dental
May 1999 11d
IMPLA-MED LOW MARGIN ABUTMENTS, SCREWDRIVER, POLISHING PROTECTOR
K946198 · DZE Implant, Endosseous,... · Dental
Jun 1995 176d
Filters
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