Institut Straumann AG: FDA filings under this applicant name

FDA lists 90 510(k) clearances under the applicant name “Institut Straumann AG” (first 1990, latest 2026), across 12 product codes in 2 review panels. Median 510(k) review time under this name: 138 days. Since 2017 the median was 163 days, against 181 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.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Institut Straumann AG took a median 163 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 181 days.

Top product codes

Plus 2 more product codes.

Review panels

• Dental (87)
• General Hospital (3)

Most recent Institut Straumann AG 510(k) clearances

80 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Institut Straumann AG.

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.

Device clinical trials

An industry sponsor named Institut Straumann AG is the lead sponsor of 20 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:

• NCT07518615: Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon (Recruiting, started 2026-01-22)
• NCT03737357: Dental Implants With a SLActive® vs. SLA® Surface (Completed, started 2019-10-09)
• NCT03908177: Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national RCT. (Completed, started 2019-09-07)
• NCT02877433: 4 mm Implants in Fixed Cross-Arch Prostheses (Completed, started 2016-08)
• NCT02569671: Bone Level Tapered Multi-Center Study (Completed, started 2016-03)

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.

• Institut Georges Lopez (3 510(k)s)
• Institut National Des Radioelements (2 510(k)s)
• Institut Straumann SA (2 510(k)s)
• Institut Biochimique SA (Ibsa) (1 510(k)s)
• Institut Geroges Lopez (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Institut Straumann AG?

FDA lists 90 510(k) clearances under the applicant name “Institut Straumann AG” (first 1990, latest 2026), across 12 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 Institut Straumann AG?

The median time from FDA receipt to decision across 510(k)s cleared under the name Institut Straumann AG is 138 days. Since 2017: 163 days, versus 181 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Institut Straumann AG?

The most frequent FDA product codes under this applicant name are NHA (Abutment, Implant, Dental, Endosseous, 46); DZE (Implant, Endosseous, Root-Form, 30); EIH (Powder, Porcelain, 3).

Next steps

• See all 90 Institut Straumann AG clearances with predicates and recalls
• Run predicate analysis for product code NHA, Institut Straumann AG'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.

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