EMS Piezon Master 600
FDA 510(k) K022328 · Electro Medical Systems SA
510(k) numberK022328
Submission
- Device name
- EMS Piezon Master 600
- Applicant
- Electro Medical Systems SA
North Attleboro, MA, US - Received
- July 18, 2002
- Decision date
- August 13, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code ELC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260773 | Varios Combi Pro2ELC · Traditional | Nakanishi, Inc. | 03/10/2026SE |
| K253254 | GBT Machine Airflow Prophylaxis MasterELC · Traditional | E.M.S Electro Medical Systems S.A | 01/28/2026SE |
| K251689 | Varios 170 Lux Scaler System (VA170LUXS10); Varios 170 Lux Scaler System (VA170LUXS11)…ELC · Traditional | Nakanishi, Inc. | 09/19/2025SE |
| K242317 | Integrated Endo System (Meet Endo-II)ELC · Traditional | Denjoy Dental Co., Ltd. | 02/13/2025SE |
| K233844 | OdneCleanELC · Traditional | Odne AG | 08/08/2024SE |
| K240707 | Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-J…ELC · Traditional | Shenzhen Micro Electric Intelligence Co., Ltd. | 07/02/2024SE |
| K240801 | BioSonic US200 Ultrasonic Scaler (60034537)ELC · Traditional | Dent4you AG | 07/01/2024SE |
| K233922 | SP Newtron Can-A; Module Newtron Can-A Emb; Support Xinetic; NWT Can Slim LED Cord G3…ELC · Traditional | Satelec - Acteon Group | 03/11/2024SE |
| K223340 | EDS Calculus Softener TURBO CRELC · Traditional | Essential Dental Systems, Inc. | 12/11/2023SE |
| K230641 | Ultrasonic Scaler TipsELC · Traditional | Guilin Refine Medical Instrument Co., Ltd. | 11/21/2023SE |
More from Guilin Refine Medical Instrument Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K022119 | EMS Air-Flow Handy 2 Dental HandpieceEFB · Special | 07/25/2002SE |
| K012445 | EMS Swiss Lithoclast Master (A.K.A. Swiss Lithoclast Ultra)FFK · Special | 08/24/2001SE |
| K002484 | EMS Swiss Orthoclast Chisels for Non-Cemented Prosthesis RemovalJDX · Traditional | 10/04/2000SE |
| K991857 | Airflow HandyEFB · Traditional | 10/07/1999SE |
| K992251 | Swiss Lithoclast Multipurpose ProbeFFK · Special | 07/27/1999SE |
| K965203 | Radx SystemEHD · Traditional | 03/17/1997SE |
| K963285 | EMS Swiss Lithoclast LithotripterFFK · Traditional | 02/13/1997SE |
| K964111 | Lithovac Suction/Aspiration ProbeKQT · Traditional | 12/16/1996SE |
| K953026 | MinipiezonELC · Traditional | 08/28/1995SE |
| K951531 | Swiss Lithoclast LithotripterFFK · Traditional | 08/24/1995SE |
Questions and answers
When was EMS Piezon Master 600 cleared by the FDA?
EMS Piezon Master 600 (K022328) received a 510(k) decision of Substantially Equivalent on August 13, 2002, 26 days after the submission was received.
What is the product code of K022328?
The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.