The Straumann Co.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “The Straumann Co.” (first 1992, latest 2004), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 104 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 8 | 8 |
| DZL | Screw, Fixation, Intraosseous | 1 | 1 |
| GDM | Needle, Aspiration And Injection, Reusable | 1 | 1 |
| JEY | Plate, Bone | 1 | 1 |
| LYC | Bone Grafting Material, Synthetic | 1 | 1 |
| NHA | Abutment, Implant, Dental, Endosseous | 1 | 1 |
| OAT | Implant, Endosseous, Orthodontic | 1 | 1 |
Review panels
- Dental (13)
- General and Plastic Surgery (1)
Most recent The Straumann Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041070 | STRAUMANN TEMPORARY COPING | NHA | 2004-07-23 | 88 |
| K040646 | STRAUMANN GRANULES | LYC | 2004-05-03 | 53 |
| K040469 | THE STRAUMANN ORTHO IMPLANT SYSTEM | OAT | 2004-04-30 | 66 |
| K993862 | MODUS SAGITTAL SPLIT PLATE | JEY | 1999-12-29 | 44 |
| K962023 | PLASTIC PROTECTION HEALING CAPS | DZE | 1996-08-15 | 84 |
| K960634 | TITANIUM HEALING CAPS | DZE | 1996-06-18 | 125 |
| K955281 | ENDOSSEOUS DENTAL IMPLANT & ACCESSORIES | DZE | 1996-03-15 | 120 |
| K955369 | MEMFIX | DZL | 1996-01-23 | 60 |
| K941393 | ITI ANGLED ABUTMENT | DZE | 1995-06-14 | 449 |
| K943720 | ITI TRANSVERSAL SCREWING SYSTEM | DZE | 1995-03-24 | 235 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named The Straumann Co..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under The Straumann Co.?
FDA lists 14 510(k) clearances under the applicant name “The Straumann Co.” (first 1992, latest 2004), across 7 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by The Straumann Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Straumann Co. is 104 days.
Which FDA product codes appear under The Straumann Co.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 8); DZL (Screw, Fixation, Intraosseous, 1); GDM (Needle, Aspiration And Injection, Reusable, 1).
Next steps
- See all 14 The Straumann Co. clearances with predicates and recalls
- Run predicate analysis for product code DZE, The Straumann Co.'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.