510(k) K042787

IS 40 MICROMOTOR by Satelec — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2004
Date Received
October 6, 2004
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