510(k) K031326

IMAGINE REFLEX by Wieland Dental + Technik GmbH & Co. KG — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2003
Date Received
April 25, 2003
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