Neoss, Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Neoss, Ltd.” (first 2005, latest 2022), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 144 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 294 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 2 | 175 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 377 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Neoss, Ltd. took a median 377 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 191 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 4 | 4 |
| NHA | Abutment, Implant, Dental, Endosseous | 4 | 4 |
| NPK | Barrier, Synthetic, Intraoral | 1 | 1 |
Review panels
- Dental (9)
Most recent Neoss, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211396 | Neoss Individual Prosthetics | NHA | 2022-05-17 | 377 |
| K150669 | Neoss TiBase, Neoss CoCr Abutments (Mono and Multi) | NHA | 2015-10-08 | 206 |
| K143327 | Neoss Ti Reinforced Membrane | NPK | 2015-04-13 | 144 |
| K113376 | NEOSS PROACTIVE TAPERED IMPLANT | DZE | 2012-09-05 | 294 |
| K090452 | NEOSS IMPLANT SYSTEM 03.25 | DZE | 2009-05-22 | 88 |
| K081851 | NEOSS ACCESS ABUTMENTS | NHA | 2009-03-02 | 245 |
| K083561 | NEOSS PROACTIVE IMPLANT | DZE | 2009-02-11 | 71 |
| K071838 | NEOSS VARIOUS TITANIUM ABUTMENTS | NHA | 2007-10-19 | 106 |
| K043195 | NEO IMPLANT SYSTEM | DZE | 2005-03-07 | 109 |
Recalls
openFDA lists no recalls under a recalling firm named Neoss, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Neoss Limited (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Neoss, Ltd.?
FDA lists 9 510(k) clearances under the applicant name “Neoss, Ltd.” (first 2005, latest 2022), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Neoss, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neoss, Ltd. is 144 days.
Which FDA product codes appear under Neoss, Ltd.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 4); NHA (Abutment, Implant, Dental, Endosseous, 4); NPK (Barrier, Synthetic, Intraoral, 1).
Next steps
- See all 9 Neoss, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Neoss, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.