510(k) K080089

SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS by Sybron Dental Specialties, Inc. — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2008
Date Received
January 14, 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