510(k) K120239

ELEVANCE by Midmark — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2012
Date Received
January 26, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Operative Dental
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type