510(k) K152064

Astringedent Clear by Ultradent Products, Inc. — Product Code MVL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2015
Date Received
July 24, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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