Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neoss, Ltd. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
144 daysmedian FDA review time
377 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211396 | Neoss Individual Prosthetics | Neoss, Ltd. | 2022-05-17 | 377 | 0 |
| K150669 | Neoss TiBase, Neoss CoCr Abutments (Mono and Multi) | Neoss, Ltd. | 2015-10-08 | 206 | 0 |
| K143327 | Neoss Ti Reinforced Membrane | Neoss, Ltd. | 2015-04-13 | 144 | 0 |
| K113376 | NEOSS PROACTIVE TAPERED IMPLANT | Neoss, Ltd. | 2012-09-05 | 294 | 0 |
| K090452 | NEOSS IMPLANT SYSTEM 03.25 | Neoss, Ltd. | 2009-05-22 | 88 | 0 |
| K081851 | NEOSS ACCESS ABUTMENTS | Neoss, Ltd. | 2009-03-02 | 245 | 0 |
| K083561 | NEOSS PROACTIVE IMPLANT | Neoss, Ltd. | 2009-02-11 | 71 | 0 |
| K071838 | NEOSS VARIOUS TITANIUM ABUTMENTS | Neoss, Ltd. | 2007-10-19 | 106 | 0 |
| K043195 | NEO IMPLANT SYSTEM | Neoss, Ltd. | 2005-03-07 | 109 | 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