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510(k) K162856

Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) by Bonart Co., Ltd. — Product Code EGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2017
Date Received
October 12, 2016
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Contra- And Right-Angle Attachment, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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  • 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)

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