Home / 510(k) Clearances / K992504

510(k) K992504

EMS KERMIT by (Ems Sa) Electro Medical Systems — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2000
Date Received
July 27, 1999
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 (Ems Sa) Electro Medical Systems

  • K073284 — AIR-FLOW MASTER STANDARD (December 14, 2007)
  • K032099 — SWISS MASTER LIGHT (October 27, 2003)
  • K991874 — EMS SURFACE MOUNT SCALER (July 30, 1999)
  • K991588 — EMS SWISS ORTHOCLAST (July 21, 1999)

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)