Home / 510(k) Clearances / K071981

510(k) K071981

BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS) by Bonart Co., Ltd. — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2007
Date Received
July 18, 2007
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 Bonart Co., Ltd.

  • K162856 — Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) (July 18, 2017)
  • K152125 — Oral Surgery System and Accessories (August 15, 2016)
  • K100785 — BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES (December 3, 2010)
  • K082971 — BONART ART-L5 LED CORDLESS CURING LIGHT (November 13, 2008)
  • K081550 — BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO (August 28, 2008)
  • K080761 — BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES (August 25, 2008)
  • K062289 — BONART ART-L3 LED CURING LIGHT (January 3, 2007)
  • K061448 — BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES (August 17, 2006)
  • K052028 — BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS) (October 28, 2005)
  • K023721 — BONART ART-L2 LIGHT CURING UNIT (January 10, 2003)

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)