Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Northern Implants, LLC · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K061169 | ENDOSSEOUS DENTAL IMPLANT | Northern Implants, LLC | 2006-06-20 | 54 | 0 |
| K053478 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Northern Implants, LLC | 2006-04-05 | 112 | 0 |
| K052490 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Northern Implants, LLC | 2005-12-08 | 87 | 0 |
| K033171 | NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING | Northern Implants, LLC | 2004-04-27 | 210 | 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