510(k) K072555

EDTA PLUS by Essential Dental Systems, Inc. — Product Code KJJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2007
Date Received
September 10, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleanser, Root Canal
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type