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510(k) K010195

PREMIER ULTRASONIC SCALER AND INSERTS by Premier Dental Products Co. — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2001
Date Received
January 22, 2001
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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