Home / 510(k) Clearances / K140990

510(k) K140990

EMS PIEZON 707 BIK AND PIEZON 707 BIK LED by E.M.S Electro Medical Systems S.A — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2015
Date Received
April 17, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scaler, Ultrasonic
Device Class
Class II
Regulation Number
872.4850
Review Panel
DE
Submission Type

Other clearances by E.M.S Electro Medical Systems S.A

  • K253254 — GBT Machine Airflow Prophylaxis Master (January 28, 2026)
  • K243279 — DOLORCLAST Focused Shock Waves (August 13, 2025)
  • K230893 — Swiss LthoClast Trilogy (October 23, 2023)
  • K220538 — DolorClast Radial (July 11, 2022)
  • K190124 — EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One (October 20, 2019)
  • K191079 — Piezon Built-in Kit, Piezon Built-in Kit LED (August 16, 2019)
  • K191124 — Swiss LithoClast Trilogy (May 29, 2019)
  • K182490 — Swiss LithoClast Trilogy (October 9, 2018)
  • K181997 — Swiss LithoClast Trilogy (August 30, 2018)
  • K181364 — Swiss LithoClast Trilogy (June 20, 2018)

Other clearances for product code ELC

  • K260773 — Varios Combi Pro2 (March 10, 2026)
  • K253254 — GBT Machine Airflow Prophylaxis Master (January 28, 2026)
  • K251689 — VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170L (September 19, 2025)
  • K242317 — Integrated Endo System (Meet Endo-II) (February 13, 2025)
  • K233844 — OdneClean (August 8, 2024)
  • K240707 — Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY- (July 2, 2024)
  • K240801 — BioSonic US200 Ultrasonic Scaler (60034537) (July 1, 2024)
  • K233922 — SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CO (March 11, 2024)
  • K223340 — EDS Calculus Softener TURBO CR (December 11, 2023)
  • K230641 — Ultrasonic Scaler Tips (November 21, 2023)