510(k) K033675

PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER by Sirona Dental Systems GmbH — Product Code KOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2004
Date Received
November 24, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Airbrush
Device Class
Class II
Regulation Number
872.6080
Review Panel
DE
Submission Type