Anthogyr: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Anthogyr” (first 2004, latest 2024), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 126 days. Since 2017 the median was 265 days, against 191 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 407 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 3 | 120 |
| 2024 | 1 | 265 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Anthogyr took a median 265 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 |
|---|---|---|---|
| EFA | Handpiece, Belt And/Or Gear Driven, Dental | 3 | 3 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 3 | 3 |
| DZE | Implant, Endosseous, Root-Form | 1 | 1 |
| EJI | Syringe, Cartridge | 1 | 1 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 1 | 1 |
| NHA | Abutment, Implant, Dental, Endosseous | 1 | 1 |
Review panels
- Dental (7)
- General Hospital (3)
Most recent Anthogyr 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231072 | Anthogyr FlexiBase® titanium bases for Axiom® BL | NHA | 2024-01-04 | 265 |
| K233264 | Anthogyr INTEGRAL Guided Surgery Cassettes | KCT | 2023-12-22 | 84 |
| K230104 | Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL | DZE | 2023-10-16 | 276 |
| K230680 | Anthogyr Surgical Cassettes | KCT | 2023-07-11 | 120 |
| K160730 | Instrument kits | KCT | 2017-04-27 | 407 |
| K093894 | ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE | EFA | 2010-03-03 | 75 |
| K090676 | MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES | EFA | 2009-05-22 | 70 |
| K040671 | EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES | EJI | 2004-12-14 | 274 |
| K041279 | IMPLANTEO IMPLANTOLOGY MOTOR | EKX | 2004-09-23 | 133 |
| K040674 | IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES | EFA | 2004-06-30 | 107 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2016-06-20.
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 Anthogyr is the lead sponsor of 2 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT05768295: Multicentric Observational Study Confirming the Performance and Safety of the Axiom® BL X3 Implants (Active not recruiting, started 2023-04-05)
- NCT05223387: Tissue Level vs Bone Level Implants for Plural Restorations : a Multicentre Randomised Controlled Trial (Active not recruiting, started 2022-03-30)
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 Sas (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Anthogyr?
FDA lists 10 510(k) clearances under the applicant name “Anthogyr” (first 2004, latest 2024), across 6 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 Anthogyr?
The median time from FDA receipt to decision across 510(k)s cleared under the name Anthogyr is 126 days. Since 2017: 265 days, versus 191 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Anthogyr?
The most frequent FDA product codes under this applicant name are EFA (Handpiece, Belt And/Or Gear Driven, Dental, 3); KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 3); DZE (Implant, Endosseous, Root-Form, 1).
Next steps
- See all 10 Anthogyr clearances with predicates and recalls
- Run predicate analysis for product code EFA, Anthogyr'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.