510(k) K100182

SALVIN DENTAL SPECIALTIES FIXATION SCREW by Salvin Dental Specialties, Inc. — Product Code DZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2010
Date Received
January 21, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Intraosseous
Device Class
Class II
Regulation Number
872.4880
Review Panel
DE
Submission Type