Home / 510(k) Clearances / K132609

510(k) K132609

EDS ULTRASONIC TIPS by Essential Dental Systems, Inc. — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2014
Date Received
August 20, 2013
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 Essential Dental Systems, Inc.

  • K223340 — EDS Calculus Softener TURBO CR (December 11, 2023)
  • K202281 — EDS Bioceramic Sealer (Bioseal) (February 12, 2021)
  • K152691 — EDS Universal Cement (February 25, 2016)
  • K140846 — EDS COMBO-RINSE (July 25, 2014)
  • K111541 — ENDO-EXPRESS (R) HANDPIECE (March 16, 2012)
  • K101504 — TI-CORE FLOW (October 29, 2010)
  • K072555 — EDTA PLUS (December 13, 2007)
  • K070401 — ENDO-CHX (July 11, 2007)
  • K063856 — EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM (February 6, 2007)
  • K943475 — ULTRA HYDROPHILIC ALGINAE (August 12, 1994)

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)