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510(k) K082973

STER-MATE STERILE LAVAGE KIT by Dentsply Interntional — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2009
Date Received
October 6, 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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