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510(k) K081550

BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO by Bonart Co., Ltd. — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2008
Date Received
June 3, 2008
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

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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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