Manufacturer registered with FDA
Electro Medical Systems SA
Southlake, TX, United States. Lists 5 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 25
- 510(k) clearances
- 51995–2002
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 1990–2026
Devices listed with FDA
What 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 | AIR-FLOW MASTER PIEZONAIR-FLOW S2EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneEMS PIEZON 707 BIKminiMasterminiMaster LEDminiPiezonPiezon 150Piezon 250PIEZON BUILT-IN KIT - S5 BIK, S5 BIK T; PIEZON BUILT-IN KIT LED - S5L BIK, S5L BIK T 2 morePiezon Master 600 Handpiece onlyPiezon Master 700 | 2022 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | AIR-FLOW HANDY 2+AIR-FLOW handy 3AIR-FLOW handy 3 PERIOAIR-FLOW handy 3 PLUSAIR-FLOW HANDY PERIOAIR-FLOW MASTER PERIOAIR-FLOW MASTER PIEZONPERIO-FLOW Nozzle | 2022 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | AIR-FLOW CLASSIC Prophylaxis Powder; AIR-FLOW PERIO Prophylaxis Powder; AF SOFT Prophylaxis Powder; AF COMFORT; AF PERIOAIR-FLOW MASTER PIEZONAIR-FLOW PLUS Prophylaxis Powder; AIRFLOW PLUS | 2022 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Maker | Piezon Master Surgery | 2022 |
| Rotary ScalerELB · Class 2 | — | Maker | MiniEndo III | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Electro Medical Systems SA as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 13 Aug 2002 | K022328 | EMS PIEZON MASTER 600 | ELC Ultrasonic Scaler |
| 25 Jul 2002 | K022119 | EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE | EFB Dental Air-Powered Handpiece |
| 7 Oct 1999 | K991857 | AIRFLOW HANDY | EFB Dental Air-Powered Handpiece |
| 17 Mar 1997 | K965203 | RADX SYSTEM | EHD Extraoral with Timer X-Ray Unit |
| 28 Aug 1995 | K953026 | MINIPIEZON | ELC Ultrasonic Scaler |
Some of these clearances are listed with FDA today by another company: EMS Electro Medical Systems SA (1).
Also lists devices cleared under other names
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 (17), Sybron Dental Specialties (1), Electro Medical Systems (Ems Sa) (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 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 |
| 3 Feb 2016 | K151912 | AIR-FLOW handy 3.0 PLUS | E.M.S Electro Medical Systems S.A | EFB Dental Air-Powered Handpiece |
| 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 |
| 22 Nov 2013 | K132443 | PIEZON 150 | E.M.S Electro Medical Systems S.A | ELC Ultrasonic Scaler |
| 7 Apr 2011 | K110173 | EMS AIR-FLOW MASTER PIEZON | E.M.S Electro Medical Systems S.A | ELC Ultrasonic Scaler |
| 8 Sep 2010 | K093723 | EMS MINIMASTER LED | E.M.S Electro Medical Systems S.A | ELC Ultrasonic Scaler |
| 30 Jul 2010 | K093000 | EMS PIEZON MASTER 700 | E.M.S Electro Medical Systems S.A | ELC Ultrasonic Scaler |
| 20 Oct 2009 | K092289 | EMS AIR-FLOW HANDY PERIO | E.M.S Electro Medical Systems S.A | EFB Dental Air-Powered Handpiece |
| 18 Feb 2009 | K082791 | EMS AIR-FLOW MASTER | E.M.S Electro Medical Systems S.A | EFB Dental Air-Powered Handpiece |
| 18 Dec 2007 | K072146 | EMS PIEZON MASTER SURGERY | E.M.S Electro Medical Systems S.A | DZI Powered Bone Drill |
| 30 Mar 2005 | K050710 | MINIMASTER ULTRASONIC SCALER | E.M.S Electro Medical Systems S.A | ELC Ultrasonic Scaler |
| 22 Feb 2001 | K003640 | MINIENDO III | Sybron Dental Specialties | ELB Rotary Scaler |
| 18 Apr 1990 | K900709 | AIR FLOW SII | Electro Medical Systems (Ems Sa) | ELC Ultrasonic Scaler |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ELECTRO MEDICAL SYSTEMS, L.L.C.FDA reg. 1648564 | Southlake, TX, United States | Remanufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9025157). 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.