Anthogyr Sas: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Anthogyr Sas” (first 2011, latest 2017), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 236 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 2 | 209 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 415 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Anthogyr Sas took a median 415 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 221 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 4 | 4 |
| EBW | Controller, Foot, Handpiece And Cord | 1 | 1 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 | 1 |
Review panels
- Dental (6)
Most recent Anthogyr Sas 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161177 | Axiom PX | DZE | 2017-06-15 | 415 |
| K141450 | AXIOM 2.8 | DZE | 2014-09-17 | 107 |
| K131066 | AXIOM REG | DZE | 2014-02-21 | 311 |
| K111532 | MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE | EGS | 2011-10-07 | 126 |
| K102241 | ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT | EBW | 2011-03-23 | 226 |
| K101913 | ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM | DZE | 2011-03-11 | 246 |
Recalls
openFDA lists no recalls under a recalling firm named Anthogyr Sas.
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.
- Anthogyr (10 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Anthogyr Sas?
FDA lists 6 510(k) clearances under the applicant name “Anthogyr Sas” (first 2011, latest 2017), 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 Anthogyr Sas?
The median time from FDA receipt to decision across 510(k)s cleared under the name Anthogyr Sas is 236 days.
Which FDA product codes appear under Anthogyr Sas?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 4); EBW (Controller, Foot, Handpiece And Cord, 1); EGS (Handpiece, Contra- And Right-Angle Attachment, Dental, 1).
Next steps
- See all 6 Anthogyr Sas clearances with predicates and recalls
- Run predicate analysis for product code DZE, Anthogyr Sas'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.