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510(k) K080761

BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES by Bonart Co., Ltd. — Product Code DZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2008
Date Received
March 18, 2008
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

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  • 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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