Satelec - Acteon Group: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Satelec - Acteon Group” (first 2007, latest 2024), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 214 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 | 2 | 154 |
| 2013 | 1 | 151 |
| 2014 | 4 | 250 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 290 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 89 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Satelec - Acteon Group took a median 190 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 222 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ELC | Scaler, Ultrasonic | 7 | 7 |
| DZI | Drill, Bone, Powered | 2 | 2 |
| EBW | Controller, Foot, Handpiece And Cord | 1 | 1 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 | 1 |
Review panels
- Dental (11)
Most recent Satelec - Acteon Group 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233922 | SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG | ELC | 2024-03-11 | 89 |
| K172137 | PIEZOTOME CUBE | DZI | 2018-05-03 | 290 |
| K131906 | SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE | EBZ | 2014-04-11 | 289 |
| K132322 | NEWTRON P5 XS B.LED | ELC | 2014-03-11 | 229 |
| K132267 | NEWTRON P5, NEWTRON P5 B.LED | ELC | 2014-03-10 | 231 |
| K131151 | ENDOCENTER | ELC | 2014-01-16 | 268 |
| K131997 | NEWTRON BOOSTER | ELC | 2013-11-26 | 151 |
| K113430 | PROULTRA PIEZO ULTRASONIC | ELC | 2012-02-23 | 94 |
| K111623 | I-ENDO DUAL | EBW | 2012-01-10 | 214 |
| K072030 | IMPLANT CENTER | DZI | 2007-11-19 | 118 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Satelec - Acteon Group.
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.
- Satelec (24 510(k)s)
- Satelec - Acteon, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Satelec - Acteon Group?
FDA lists 11 510(k) clearances under the applicant name “Satelec - Acteon Group” (first 2007, latest 2024), across 4 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 Satelec - Acteon Group?
The median time from FDA receipt to decision across 510(k)s cleared under the name Satelec - Acteon Group is 214 days.
Which FDA product codes appear under Satelec - Acteon Group?
The most frequent FDA product codes under this applicant name are ELC (Scaler, Ultrasonic, 7); DZI (Drill, Bone, Powered, 2); EBW (Controller, Foot, Handpiece And Cord, 1).
Next steps
- See all 11 Satelec - Acteon Group clearances with predicates and recalls
- Run predicate analysis for product code ELC, Satelec - Acteon Group'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.