510(k) K170420

n!ce Glass Ceramic Blocks for Amann Girrbach by Institut Straumann AG — Product Code EIH

K170420 is an FDA 510(k) premarket notification submitted by Institut Straumann AG for the device "n!ce Glass Ceramic Blocks for Amann Girrbach". The FDA issued a decision of Substantially Equivalent on Mar 2, 2017. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Institut Straumann AG has 91 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 2, 2017
Date Received
Feb 13, 2017
Clearance Type
Special
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
510(k)