Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Sterngold — Predicate Candidate Screening

12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

69 daysmedian FDA review time

169 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K092434	STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM	Sterngold	2009-11-10	95
K041271	STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM	Sterngold	2004-10-28	169
K023580	STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM	Sterngold	2003-01-17	85
K022252	STERNGOLD 1, MODEL 1127781	Sterngold	2002-09-19	69
K021045	ERA IMPLANT	Sterngold	2002-06-26	86
K021741	CRITERTION, MODEL #1067511	Sterngold	2002-06-26	29
K021367	STERNGOLD 66, MODEL #1180230	Sterngold	2002-05-16	16
K020949	APOLLO, MODEL 1124525	Sterngold	2002-04-04	10
K020391	STERN MICRO ERA ATTACHMENT SYSTEM	Sterngold	2002-03-08	30
K003007	GALAXY	Sterngold	2000-11-17	52
K991436	STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELAT	Sterngold	1999-05-07	11
K946198	IMPLA-MED LOW MARGIN ABUTMENTS, SCREWDRIVER, POLISHING PROTE	Sterngold	1995-06-14	176

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda