510(k) K053438

GLASS CERAMICS by 3M Espe AG Dental Products — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2006
Date Received
December 9, 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