Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Southern Implants, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
101 daysmedian FDA review time
330 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093562 | ENDOSSEOUS DENTAL IMPLANT | Southern Implants, Inc. | 2010-10-14 | 330 | 0 |
| K082651 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Southern Implants, Inc. | 2008-12-22 | 101 | 0 |
| K071161 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Southern Implants, Inc. | 2007-11-16 | 204 | 1 |
| K070841 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Southern Implants, Inc. | 2007-06-21 | 86 | 0 |
| K070905 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Southern Implants, Inc. | 2007-05-24 | 52 | 1 |
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