510(k) K050903

XAWEX G 100 by Wieland Dental + Technik GmbH & Co. KG — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2005
Date Received
April 11, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powder, Porcelain
Device Class
Class II
Regulation Number
872.6660
Review Panel
DE
Submission Type