Satelec-Acteon Group
MERIGNAC Gironde, FR
SATELEC-ACTEON GROUP appears in FDA device records in MERIGNAC Gironde, FR. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Satelec-Acteon Group between 2007 and 2024. The busiest year on record is 2014, with 4. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 2 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 4 |
| 2018 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | Substantially Equivalent | |
| K172137 | PIEZOTOME CUBE | DZI | Substantially Equivalent | |
| K131906 | SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE | EBZ | Substantially Equivalent | |
| K132322 | NEWTRON P5 XS B.LED | ELC | Substantially Equivalent | |
| K132267 | NEWTRON P5, NEWTRON P5 B.LED | ELC | Substantially Equivalent | |
| K131151 | ENDOCENTER | ELC | Substantially Equivalent | |
| K131997 | NEWTRON BOOSTER | ELC | Substantially Equivalent | |
| K113430 | PROULTRA PIEZO ULTRASONIC | ELC | Substantially Equivalent | |
| K111623 | I-ENDO DUAL | EBW | Substantially Equivalent | |
| K072030 | IMPLANT CENTER | DZI | Substantially Equivalent | |
| K071424 | PMAX NEWTRON XS | ELC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8044015 | 3004536551 | SATELEC-ACTEON GROUP | Z.I. DU PHARE, MERIGNAC Gironde 33708 FR | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EBZActivator, Ultraviolet, For Polymerization
- EBWController, Foot, Handpiece And Cord
- LWMDevice, Electrical Dental Anesthesia
- DZIDrill, Bone, Powered
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)
- EFBHandpiece, Air-Powered, Dental
- EKXHandpiece, Direct Drive, Ac-Powered
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- JDXInstrument, Surgical, Sonic And Accessory/Attachment
- ERAOtoscope
- NYHPlaque Disclosing Kit
- ELCScaler, Ultrasonic
- EKZUnit, Electrosurgical, And Accessories, Dental
- EIAUnit, Operative Dental
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Satelec-Acteon Group edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain