Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sterngold/Implamed — Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
37 daysmedian FDA review time
87 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K984341 | STERNVANTAGE VARNISH LC, MODEL 221001 | Sterngold/Implamed | 1999-01-08 | 35 | 0 |
| K984340 | STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281 | Sterngold/Implamed | 1999-01-08 | 35 | 0 |
| K983786 | STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED | Sterngold/Implamed | 1998-11-13 | 17 | 0 |
| K982692 | STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEG | Sterngold/Implamed | 1998-10-22 | 80 | 0 |
| K982895 | STERNOMEGA COMPOMER CEMENT | Sterngold/Implamed | 1998-10-09 | 53 | 0 |
| K981516 | STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IM | Sterngold/Implamed | 1998-05-11 | 13 | 0 |
| K962325 | QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015) | Sterngold/Implamed | 1996-07-24 | 37 | 0 |
| K962324 | STERNGOLD U-CPF METAL ALLOY (1067800) | Sterngold/Implamed | 1996-07-24 | 37 | 0 |
| K962326 | STERNGOLD BIO-5 (1127210) | Sterngold/Implamed | 1996-07-24 | 37 | 0 |
| K962304 | STERNGOLD BIO-4 | Sterngold/Implamed | 1996-07-23 | 36 | 0 |
| K962303 | STERNGOLD CF | Sterngold/Implamed | 1996-07-18 | 31 | 0 |
| K962302 | PEGASUS DENTAL ALLOY | Sterngold/Implamed | 1996-07-18 | 31 | 0 |
| K960956 | STERNGOLD M-PF YELLOW CROWN & BRIDGE ALLOY MODEL 1127200 | Sterngold/Implamed | 1996-05-29 | 79 | 0 |
| K950213 | THE STERN ROOT ANCHOR SYSTEM | Sterngold/Implamed | 1995-03-23 | 63 | 0 |
| K913348 | THE STERN ERA SYSTEM | Sterngold/Implamed | 1992-01-30 | 188 | 0 |
| K914764 | STERN ERA IMPLANT ABUTMENT | Sterngold/Implamed | 1992-01-17 | 87 | 0 |
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