510(k) K080939

SURGICAL HANDPIECES, MIKRO SAW HANDPIECES by W&H Dentalwerk Buermoos GmbH — Product Code KMW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2008
Date Received
April 3, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Rotary Bone Cutting
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type