ELECTRO MEDICAL SYSTEMS, L.L.C.

FDA Device Registration & Listing · Southlake, TX, US · Registration 1648564

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1648564
FEI Number
3000205943
Entity Name
ELECTRO MEDICAL SYSTEMS, L.L.C.
City/State/Country
Southlake, TX, US
Establishment Address
2150E Continental Boulevard, Southlake, TX 76092, US
Establishment Type(s)
Repack or Relabel Medical Device,Remanufacture Medical Device
Owner / Operator
ELECTRO MEDICAL SYSTEMS, INC. (Owner Number: 9025157)
Owner / Operator Contact Address
2150 E Continental Blvd, Southlake, TX 76092, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K171174
PMA Number
N/A

All Registered Proprietary Names

Piezon Master Surgery Piezon Master 700 AIR-FLOW S2 AIR-FLOW MASTER PIEZON Swiss LithoClast Trilogy EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One AIR-FLOW handy 3 PLUS EMS PIEZON 707 BIK PIEZON BUILT-IN KIT - S5 BIK, S5 BIK T; PIEZON BUILT-IN KIT LED - S5L BIK, S5L BIK T Swiss LithoClast Trilogy LITHOCLAST MASTER HANDPIECE & 3.2MM PROBE Swiss LithoClast Trilogy AIR-FLOW PLUS Prophylaxis Powder; AIRFLOW PLUS AIR-FLOW CLASSIC Prophylaxis Powder; AIR-FLOW PERIO Prophylaxis Powder; AF SOFT Prophylaxis Powder; AF COMFORT; AF PERIO ASPIRATION PROBE; LITHOPUMP; LITHOVAC SUCTION LITHOVAC SUCTION, ASPIRATION PROBE, LITHOPUMP AIR-FLOW handy 3 Piezon Master 600 Handpiece only DOLORCLAST RADIAL miniMaster SWISS LITHOCLAST; SWISS LITHOCLAST MASTER; SWISS LITHOCLAST SELECT; SWISS LITHOCLAST ULTRA AIR-FLOW HANDY PERIO AIR-FLOW MASTER PERIO AIR-FLOW HANDY 2+ Swiss LithoClast Trilogy LITHOTRIPTOR, ELECTRO-HYDRAULIC LITHOTRIPTOR, ULTRASONIC PERIO-FLOW Nozzle

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DZI Drill, Bone, Powered Dental Class 2 872.4120 2022-08-12
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2022-08-12
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2022-08-12
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2022-08-12
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2022-08-12
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2022-08-12
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2022-08-12
FEO Lithotriptor, Ultrasonic Gastroenterology, Urology Class 2 876.4480 2022-08-12
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2022-08-12
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2022-08-12
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2022-08-12
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2022-08-12
FEO Lithotriptor, Ultrasonic Gastroenterology, Urology Class 2 876.4480 2022-08-12
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2022-08-12
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2022-08-12
FEO Lithotriptor, Ultrasonic Gastroenterology, Urology Class 2 876.4480 2022-08-12
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2022-08-12
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2022-08-12
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2022-08-12
KQT Evacuator, Gastro-Urology Gastroenterology, Urology Class 2 876.4370 2022-08-12
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2022-08-12
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2022-08-12
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2023-02-21
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2022-08-12
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2022-08-12
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2022-08-12
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2022-08-12
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2022-08-12
FEO Lithotriptor, Ultrasonic Gastroenterology, Urology Class 2 876.4480 2022-08-12
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2022-08-12
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2022-08-12
FEO Lithotriptor, Ultrasonic Gastroenterology, Urology Class 2 876.4480 2022-08-12
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2022-08-12
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2022-08-12

Official Correspondent

Jean-Baptiste AMADIEU

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ELECTRO MEDICAL SYSTEMS, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K832443 California Technics, Inc. ULTRASONIC DENTAL PROPHYLAXIS UNIT 1983-09-12
K994299 Bonart Co., Ltd. ART-P3, MODEL P3-1-ART-A1 2000-03-06
K212910 Shenzhen Carejoy Technology Co., Ltd. Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece 2022-11-17
K121698 Dentsply International, Inc. NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN 2012-08-06
K885255 Candela Laser Corp. MDL-1 LASERTRIPTER(TM) 1989-06-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1648564. Last updated year: 2026. Please use registration number 1648564 when referencing this establishment in official correspondence.
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