Data / Medical devices / United States / Electro Medical Systems, L.L.C.
Electro Medical Systems, L.L.C.: FDA-registered device maker in Southlake, TX, United States, 34 510(k) clearances and 1 PMA approval
Electro Medical Systems, L.L.C. is registered with the FDA (registration 1648564) in Southlake, TX, United States. It lists 10 device types. The FDA files 34 510(k) clearances and 1 PMA approval under its listings, the newest dated July 11, 2022. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1648564
- FEI number
- 3000205943
- Address
- 2150E Continental Boulevard, Southlake, TX, United States, 76092
- Owner or operator
- ELECTRO MEDICAL SYSTEMS, INC. (9025157)
- Roles
- Remanufacturer, Repackager or relabeler
- First device listed
- August 12, 2022
- Registered through
- 2026
- Brand names listed
- AIR-FLOW CLASSIC Prophylaxis Powder; AIR-FLOW PERIO Prophylaxis Powder; AF SOFT Prophylaxis Powder; AF COMFORT; AF PERIO, AIR-FLOW HANDY 2+, AIR-FLOW HANDY PERIO, AIR-FLOW MASTER PERIO, AIR-FLOW MASTER PIEZON, AIR-FLOW PLUS Prophylaxis Powder; AIRFLOW PLUS, AIR-FLOW S2, AIR-FLOW handy 3 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Drill, Bone, Powered | DZI | 2 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Evacuator, Gastro-Urology | KQT | 2 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Generator, Shock-Wave, For Pain Relief | NBN | 3 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Handpiece, Air-Powered, Dental | EFB | 1 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Lithotriptor, Electro-Hydraulic | FFK | 2 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Lithotriptor, Ultrasonic | FEO | 2 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Remanufacturer | accessdata.fda.gov |
| Scaler, Rotary | ELB | 2 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scaler, Ultrasonic | ELC | 2 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 11, 2022 | K220538 | DolorClast Radial | ISA | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| October 20, 2019 | K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One | ELC | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| August 16, 2019 | K191079 | Piezon Built-in Kit, Piezon Built-in Kit LED | ELC | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| May 29, 2019 | K191124 | Swiss LithoClast Trilogy | FFK | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| October 9, 2018 | K182490 | Swiss LithoClast Trilogy | FEO | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| August 30, 2018 | K181997 | Swiss LithoClast Trilogy | FEO | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| June 20, 2018 | K181364 | Swiss LithoClast Trilogy | FEO | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| January 10, 2018 | K173234 | Swiss LithoClast Trilogy | FEO | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| December 18, 2017 | K171174 | PERIO-FLOW nozzle | EFB | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| September 11, 2017 | K171189 | AIR-FLOW PLUS Prophylaxis powder | EJR | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| February 3, 2016 | K151912 | AIR-FLOW handy 3.0 PLUS | EFB | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| February 27, 2015 | K140990 | EMS PIEZON 707 BIK AND PIEZON 707 BIK LED | ELC | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| April 11, 2014 | K132478 | AIR-FLOW HANDY 3.0 | EFB | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| February 24, 2014 | K132480 | AIR-FLOW HANDY 3.0 PERIO | EFB | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| December 6, 2013 | K132445 | PIEZON 250 | ELC | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| November 22, 2013 | K132443 | PIEZON 150 | ELC | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| January 16, 2013 | K123038 | SWISS LITHOBREAKER | FFK | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| April 7, 2011 | K110173 | EMS AIR-FLOW MASTER PIEZON | ELC | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| September 8, 2010 | K093723 | EMS MINIMASTER LED | ELC | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| July 30, 2010 | K093000 | EMS PIEZON MASTER 700 | ELC | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| October 20, 2009 | K092289 | EMS AIR-FLOW HANDY PERIO | EFB | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| February 18, 2009 | K082791 | EMS AIR-FLOW MASTER | EFB | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| December 18, 2007 | K072146 | EMS PIEZON MASTER SURGERY | DZI | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| March 30, 2005 | K050710 | MINIMASTER ULTRASONIC SCALER | ELC | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| August 13, 2002 | K022328 | EMS PIEZON MASTER 600 | ELC | Substantially Equivalent | Electro Medical Systems SA | accessdata.fda.gov |
| July 25, 2002 | K022119 | EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE | EFB | Substantially Equivalent | Electro Medical Systems SA | accessdata.fda.gov |
| August 24, 2001 | K012445 | EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) | FFK | Substantially Equivalent | Electro Medical Systems SA | accessdata.fda.gov |
| February 22, 2001 | K003640 | MINIENDO III | ELB | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| December 18, 1997 | K974164 | SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE | FFK | Substantially Equivalent | Medical Device Consultants, Inc. | accessdata.fda.gov |
| February 13, 1997 | K963285 | EMS SWISS LITHOCLAST LITHOTRIPTER | FFK | Substantially Equivalent | Electro Medical Systems SA | accessdata.fda.gov |
| December 16, 1996 | K964111 | LITHOVAC SUCTION/ASPIRATION PROBE | KQT | Substantially Equivalent | Electro Medical Systems SA | accessdata.fda.gov |
| August 28, 1995 | K953026 | MINIPIEZON | ELC | Substantially Equivalent | Electro Medical Systems SA | accessdata.fda.gov |
| August 24, 1995 | K951531 | SWISS LITHOCLAST LITHOTRIPTER | FFK | Substantially Equivalent | Electro Medical Systems SA | accessdata.fda.gov |
| April 18, 1990 | K900709 | AIR FLOW SII | ELC | Substantially Equivalent | Electro Medical Systems (Ems Sa) | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| May 8, 2007 | P050004 | EMS SWISS DOLORCLAST | NBN | 1 | August 28, 2009 | accessdata.fda.gov |
Compare with other makers
- All makers of Handpiece, Air-Powered, Dental
- All makers of Lithotriptor, Ultrasonic
- All makers of Lithotriptor, Electro-Hydraulic
- All makers of Scaler, Ultrasonic
- All makers of Agent, Polishing, Abrasive, Oral Cavity
- All makers of Evacuator, Gastro-Urology
Updated July 11, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.