510(k) K101104

REMIN PRO by Voco GmbH — Product Code EJR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2010
Date Received
April 20, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Polishing, Abrasive, Oral Cavity
Device Class
Class I
Regulation Number
872.6030
Review Panel
DE
Submission Type