510(k) K111541

ENDO-EXPRESS (R) HANDPIECE by Essential Dental Systems, Inc. — Product Code EGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2012
Date Received
June 2, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Contra- And Right-Angle Attachment, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type