FDA 510(k), K151455, 3Shape Abutment Designer Software

FDA 510(k), K151455, 3Shape Abutment Designer Software

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510(K) Number: K151455
Device Name: 3Shape Abutment Designer Software
Manufacturer: Hanne Nielsen
Device Classification Name: Dental Abutment Design Software For Dental Laboratory
Regulation Number: PNP
Classification Product Code: KXA
Date Received: 06/01/2015
Decision Date: 09/06/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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