510(k) K062418

K-SPRAY, MODEL 085-2715 by Scican — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2006
Date Received
August 18, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type