Manufacturer registered with FDA
EMS Electro Medical Systems SA
NYON, VAUD, Switzerland. Lists 7 dental device types with FDA across 2 registered establishments.
- Device types listed
- 7
- Brands and models
- 16
- 510(k) clearances
- 0as applicant
- Markets registered in
- 17529 registrations outside the US
- Establishments
- 2Switzerland
Registered in 17 markets
Where regulators' registries name EMS Electro Medical Systems SA as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | EMS Electro Medical Systems SA | 7 device types | — | Below |
| Canada | Health Canada | Registration holder | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. | 219 | 1999–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | E.M.S. ELECTRO MEDICAL SYSTEMS S.A.E.M.S. Electro Medical Systems S.A. · EMS ELECTRO MEDICAL SYSTEMS S.A. | 54 | 2002–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | E.M.S. Electro Medical Systems S.A. | 43 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | E.M.S. Electro Medical Systems S.A.EMS ELECTROMEDICAL SYSTEMS SA · E.M.S. ELECTRO MEDICAL SYSTEMS · +1 | 38 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | E.M.S. ELECTRO MEDICAL SYSTEMS S.A.E.M.S. Electro Medical Systems S.A. · EMS Electro Medical Systems S.A. · +2 | 37 | 1999–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | EMS Electro Medical Systems SA | 33 | 2008–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | E.M.S. Electro Medical Systems S.A. | 30 | — | Pure Global AI |
| China | NMPA | Registration holder | 瑞士医迈斯电子医疗系统有限公司E.M.S. Electro Medical Systems S.A.瑞士医迈斯电子医疗系统有限公司E.M.S.Electro Medical Systems S.A. · 瑞士医迈斯电子医疗系统有限公司 E.M.S. Electro Medical Systems S.A. · +2 | 17 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | E.M.S. Electro Medical Systems S.A. | 15 | 2022–2026 | Pure Global AI |
| Japan | PMDA | Registration holder | Ｅ．Ｍ．Ｓ．ＥＬＥＣＴＲＯ ＭＥＤＩＣＡＬ ＳＹＳＴＥＭＳ Ｓ．Ａ． | 11 | 2014–2026 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | E.M.S. Electro Medical Systems S.A. | 8 | 2013–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | E.M.S. Electro Medical Systems S.A.E.M.S ELECTRO MEDICAL SYSTEMS · E.M.S Electro Medical Systems S.A. · +1 | 8 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | E.M.S ELECTRO MEDICAL SYSTEMS S.A. | 5 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | E.M.S. Electro Medical Systems S.A. | 4 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | E.M.S. ELECTRO MEDICAL SYSTEMS S.A.EMS ELECTRO MEDICAL SYSTEMS S.A. | 4 | 2013–2024 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | EMS ELECTRO MEDICAL SYSTEMS SA | 3 | 2015–2020 | 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
Devices listed with FDA
What EMS Electro Medical Systems SA currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | AIRFLOW PROPHYLAXIS MASTER, AIRFLOW ONEGBT Machine Airflow Prophylaxis MasterOSSTEM BIKPIEZONPIEZON 250PIEZON BIK | 2007 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | AIR-FLOW HANDY 2+AIR-FLOW HANDY 3AIR-FLOW HANDY 3 PERIOPERIO-FLOW NOZZLE | 2007 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | AIR-FLOW POWDERAIRFLOW PLUS POWDER | 2017 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | GBT FLOW CONTROL | 2023 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | GBT VISIGATE | 2023 |
| AirbrushKOJ · Class 2 | — | Maker | GBT Machine Airflow Prophylaxis Master | 2026 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Lister | PIEZON MASTER SURGERY | 2007 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
EMS Electro Medical Systems SA lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: E.M.S Electro Medical Systems S.A (10), Electro Medical Systems SA (1), Electro Medical Systems (Ems Sa) (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 28 Jan 2026 | K253254 | GBT Machine Airflow Prophylaxis Master | E.M.S Electro Medical Systems S.A | ELC Ultrasonic Scaler |
| 20 Oct 2019 | K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One | E.M.S Electro Medical Systems S.A | ELC Ultrasonic Scaler |
| 16 Aug 2019 | K191079 | Piezon Built-in Kit, Piezon Built-in Kit LED | E.M.S Electro Medical Systems S.A | ELC Ultrasonic Scaler |
| 18 Dec 2017 | K171174 | PERIO-FLOW nozzle | E.M.S Electro Medical Systems S.A | EFB Dental Air-Powered Handpiece |
| 11 Sep 2017 | K171189 | AIR-FLOW PLUS Prophylaxis powder | E.M.S Electro Medical Systems S.A | EJR Oral Cavity Abrasive Polishing Agent |
| 27 Feb 2015 | K140990 | EMS PIEZON 707 BIK AND PIEZON 707 BIK LED | E.M.S Electro Medical Systems S.A | ELC Ultrasonic Scaler |
| 11 Apr 2014 | K132478 | AIR-FLOW HANDY 3.0 | E.M.S Electro Medical Systems S.A | EFB Dental Air-Powered Handpiece |
| 24 Feb 2014 | K132480 | AIR-FLOW HANDY 3.0 PERIO | E.M.S Electro Medical Systems S.A | EFB Dental Air-Powered Handpiece |
| 6 Dec 2013 | K132445 | PIEZON 250 | E.M.S Electro Medical Systems S.A | ELC Ultrasonic Scaler |
| 18 Dec 2007 | K072146 | EMS PIEZON MASTER SURGERY | E.M.S Electro Medical Systems S.A | DZI Powered Bone Drill |
| 25 Jul 2002 | K022119 | EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE | Electro Medical Systems SA | EFB Dental Air-Powered Handpiece |
| 18 Apr 1990 | K900709 | AIR FLOW SII | Electro Medical Systems (Ems Sa) | ELC Ultrasonic Scaler |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| E.M.S. ELECTRO MEDICAL SYSTEMS S.A.FDA reg. 3004096429 | NYON Vaud, Switzerland | Foreign exporter, Manufacturer, Repacker / relabeler |
| E.M.S. ELECTRO MEDICAL SYSTEMS S.A.FDA reg. 8030987 | NYON Vaud, Switzerland | Complaint file establishment, Remanufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9057430). 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.