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510(k) K152125

Oral Surgery System and Accessories by Bonart Co., Ltd. — Product Code DZI

K152125 is an FDA 510(k) premarket notification submitted by Bonart Co., Ltd. for the device "Oral Surgery System and Accessories". The FDA issued a decision of Substantially Equivalent on August 15, 2016. The device falls under product code DZI (Drill, Bone, Powered), a Class II device regulated under 21 CFR 872.4120. Bonart Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2016
Date Received
July 31, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Bone, Powered
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

Other clearances by Bonart Co., Ltd.

  • K162856 — Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) (July 18, 2017)
  • 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)
  • K071981 — BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS) (October 26, 2007)
  • 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 DZI

  • K253776 — Implantmed Plus II & Piezomed Plus II Module (June 18, 2026)
  • K254163 — VarioSurg 4 (December 23, 2025)
  • K242432 — MT-Bone (August 19, 2024)
  • K240340 — Surgical Drive System (Model: ES70, ES90, E8) (July 18, 2024)
  • K231087 — Guided Surgery Kit (August 16, 2023)
  • K192561 — TRAUS SUS20 (July 13, 2020)
  • K200265 — Surgical Drills (June 30, 2020)
  • K192033 — Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-In (June 9, 2020)
  • K172137 — PIEZOTOME CUBE (May 3, 2018)
  • K171326 — Piezosurgery White (April 13, 2018)

FDA data resources