510(k) K862110

OSSEODENT DRILLING SYSTEM by Otc/America — Product Code KMW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1986
Date Received
June 3, 1986
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