Straumann USA: FDA filings under this applicant name
FDA lists 66 510(k) clearances under the applicant name “Straumann USA” (first 1996, latest 2024), across 10 product codes in 4 review panels. Median 510(k) review time under this name: 98 days. Since 2017 the median was 161 days, against 157 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Straumann Group, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 5 | 56 |
| 2013 | 4 | 98 |
| 2014 | 6 | 139 |
| 2015 | 7 | 108 |
| 2016 | 2 | 252 |
| 2017 | 1 | 142 |
| 2018 | 1 | 218 |
| 2019 | 1 | 94 |
| 2020 | 1 | 216 |
| 2021 | 2 | 174 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 161 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Straumann USA took a median 161 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 157 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 31 | 31 |
| DZE | Implant, Endosseous, Root-Form | 27 | 27 |
| DZI | Drill, Bone, Powered | 1 | 1 |
| DZL | Screw, Fixation, Intraosseous | 1 | 1 |
| ELB | Scaler, Rotary | 1 | 1 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
| KCZ | Prosthesis, Breast, External, Used With Adhesive | 1 | 1 |
| KJJ | Cleanser, Root Canal | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| OAT | Implant, Endosseous, Orthodontic | 1 | 1 |
Review panels
- Dental (63)
- General Hospital (1)
- Radiology (1)
- General and Plastic Surgery (1)
Most recent Straumann USA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241575 | Straumann® Anatomic Healing Abutments XC (AHA) | NHA | 2024-11-11 | 161 |
| K203753 | Straumann Surgical Cassettes | KCT | 2021-07-29 | 218 |
| K202942 | Straumann 4 mm Short Implants | DZE | 2021-02-08 | 131 |
| K192401 | Straumann Screw-Retained Abutments | NHA | 2020-04-06 | 216 |
| K190662 | MRI Compatibility for Existing Straumann Dental Implant Systems | DZE | 2019-06-17 | 94 |
| K171784 | Straumann Dental Implant System | DZE | 2018-01-19 | 218 |
| K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment | DZE | 2017-03-08 | 142 |
| K151590 | Straumann RN Gold Abutment for Bridge | NHA | 2016-03-04 | 266 |
| K151328 | PURE Ceramic Implants | DZE | 2016-01-11 | 238 |
| K150899 | Straumann CARES Titanium Alloy (TAN) Abutment | NHA | 2015-09-16 | 166 |
56 earlier clearances. See the full list in Caduvo.
Recalls
26 product recalls in 21 recall events; 16 initiated in the last five years. Most recent: 2026-08-12.
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.
- Straumann Manufacturing, Inc. (4 510(k)s)
- Straumann USA, LLC (On Behalf of Institut Straumann Ag) (3 510(k)s)
- Straumann USA (On Behalf of Institut Straumann Ag) (2 510(k)s)
- Straumann Institute, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Straumann USA?
FDA lists 66 510(k) clearances under the applicant name “Straumann USA” (first 1996, latest 2024), across 10 product codes in 4 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 Straumann USA?
The median time from FDA receipt to decision across 510(k)s cleared under the name Straumann USA is 98 days. Since 2017: 161 days, versus 157 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Straumann USA?
The most frequent FDA product codes under this applicant name are NHA (Abutment, Implant, Dental, Endosseous, 31); DZE (Implant, Endosseous, Root-Form, 27); DZI (Drill, Bone, Powered, 1).
Next steps
- See all 66 Straumann USA clearances with predicates and recalls
- Run predicate analysis for product code NHA, Straumann USA'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.