Not currently registered with FDA under this name
E.M.S Electro Medical Systems S.A
Nyon, Switzerland. Named as applicant on 19 dental 510(k) clearances between 2005 and 2026. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 192005–2026
- Markets registered in
- 432 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 4 markets
Where regulators' registries name E.M.S Electro Medical Systems S.A as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | E.M.S Electro Medical Systems S.A | 19 clearances | 2005–2026 | Below |
| Brazil | ANVISA | Manufacturer | E.M.S ELECTRO MEDICAL SYSTEMS S.A | 16 | 2015–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | E.M.S. Electro Medical Systems S.AE.M.S ELECTRO MEDICAL SYSTEMS S.A · E.M.S Electro Medical Systems S.A · +1 | 11 | 2003–2026 | Pure Global AI |
| Colombia | INVIMA | Registration holder | E.M.S ELECTRO MEDICAL SYSTEMS S.A | 5 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names E.M.S Electro Medical Systems S.A as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 28 Jan 2026 | K253254 | GBT Machine Airflow Prophylaxis Master | ELC Ultrasonic Scaler |
| 20 Oct 2019 | K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One | ELC Ultrasonic Scaler |
| 16 Aug 2019 | K191079 | Piezon Built-in Kit, Piezon Built-in Kit LED | ELC Ultrasonic Scaler |
| 18 Dec 2017 | K171174 | PERIO-FLOW nozzle | EFB Dental Air-Powered Handpiece |
| 11 Sep 2017 | K171189 | AIR-FLOW PLUS Prophylaxis powder | EJR Oral Cavity Abrasive Polishing Agent |
| 3 Feb 2016 | K151912 | AIR-FLOW handy 3.0 PLUS | EFB Dental Air-Powered Handpiece |
| 27 Feb 2015 | K140990 | EMS PIEZON 707 BIK AND PIEZON 707 BIK LED | ELC Ultrasonic Scaler |
| 11 Apr 2014 | K132478 | AIR-FLOW HANDY 3.0 | EFB Dental Air-Powered Handpiece |
| 24 Feb 2014 | K132480 | AIR-FLOW HANDY 3.0 PERIO | EFB Dental Air-Powered Handpiece |
| 6 Dec 2013 | K132445 | PIEZON 250 | ELC Ultrasonic Scaler |
| 22 Nov 2013 | K132443 | PIEZON 150 | ELC Ultrasonic Scaler |
| 7 Apr 2011 | K110173 | EMS AIR-FLOW MASTER PIEZON | ELC Ultrasonic Scaler |
| 8 Sep 2010 | K093723 | EMS MINIMASTER LED | ELC Ultrasonic Scaler |
| 30 Jul 2010 | K093000 | EMS PIEZON MASTER 700 | ELC Ultrasonic Scaler |
| 20 Oct 2009 | K092289 | EMS AIR-FLOW HANDY PERIO | EFB Dental Air-Powered Handpiece |
| 18 Feb 2009 | K082791 | EMS AIR-FLOW MASTER | EFB Dental Air-Powered Handpiece |
| 18 Dec 2007 | K072146 | EMS PIEZON MASTER SURGERY | DZI Powered Bone Drill |
| 10 Aug 2007 | K071722 | DEEP BLUE | EBZ Ultraviolet Activator for Polymerization |
| 30 Mar 2005 | K050710 | MINIMASTER ULTRASONIC SCALER | ELC Ultrasonic Scaler |
Some of these clearances are listed with FDA today by another company: Electro Medical Systems SA (17), EMS Electro Medical Systems SA (10), KaVo Dental GmbH (1).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.