Home / 510(k) Clearances / K143104

510(k) K143104

Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X by Kettenbach GmbH & Co. KG — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2015
Date Received
October 29, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

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