Satelec: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Satelec” (first 1990, latest 2011), across 11 product codes in 4 review panels. Median 510(k) review time under this name: 85 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ELC | Scaler, Ultrasonic | 6 | 6 |
| EBZ | Activator, Ultraviolet, For Polymerization | 4 | 4 |
| EFB | Handpiece, Air-Powered, Dental | 4 | 4 |
| DZI | Drill, Bone, Powered | 3 | 3 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
| EIA | Unit, Operative Dental | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| JDX | Instrument, Surgical, Sonic And Accessory/Attachment | 1 | 1 |
| LBK | Neurosurgical Ultrasonic Instruments | 1 | 1 |
| LWM | Device, Electrical Dental Anesthesia | 1 | 1 |
Plus 1 more product codes.
Review panels
- Dental (21)
- Neurology (1)
- Orthopedic (1)
- General and Plastic Surgery (1)
Most recent Satelec 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K110379 | AIR-N-GO | EFB | 2011-12-08 | 301 |
| K100410 | PIEZOELECTRIC SYSTEM | JDX | 2010-04-28 | 71 |
| K091331 | PIEZOTOME 2 | DZI | 2009-12-11 | 220 |
| K091252 | IMPLANT CENTER 2 | DZI | 2009-07-22 | 84 |
| K082116 | HEMOSTASYL PASTE | MVL | 2008-12-17 | 142 |
| K072181 | MINI LED AUTOFOCUS | EBZ | 2007-09-19 | 44 |
| K071965 | I-SURGE | EFB | 2007-09-10 | 56 |
| K060275 | PIEZOTOME | ELC | 2006-05-03 | 90 |
| K060274 | PIEZOTOME | DZI | 2006-05-01 | 88 |
| K053328 | BIOSPLINT SPLINTING RIBBON | EBI | 2006-01-25 | 55 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Satelec.
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 - Acteon Group (11 510(k)s)
- Satelec - Acteon, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Satelec?
FDA lists 24 510(k) clearances under the applicant name “Satelec” (first 1990, latest 2011), across 11 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 Satelec?
The median time from FDA receipt to decision across 510(k)s cleared under the name Satelec is 85 days.
Which FDA product codes appear under Satelec?
The most frequent FDA product codes under this applicant name are ELC (Scaler, Ultrasonic, 6); EBZ (Activator, Ultraviolet, For Polymerization, 4); EFB (Handpiece, Air-Powered, Dental, 4).
Next steps
- See all 24 Satelec clearances with predicates and recalls
- Run predicate analysis for product code ELC, Satelec'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.