510(k) K123215

VISCOSTAT CLEAR by Ultradent Products, Inc. — Product Code MVL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2013
Date Received
October 15, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cord, Retraction
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type