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510(k) K052028

BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS) by Bonart Co., Ltd. — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2005
Date Received
July 27, 2005
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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  • K023721 — BONART ART-L2 LIGHT CURING UNIT (January 10, 2003)

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