FDA · official record K151455Substantially Equivalent

3Shape Abutment Designer Software

Name: 3Shape Abutment Designer Software — FDA K151455
Creator: 3Shape A/S
Keywords: 3Shape Abutment Designer Software, 3Shape Abutment Designer Software, K151455, PNP, FDA

United StatesPNP3Shape A/S

Verified

Official record identity

FDA application number: K151455
Decision date: September 06, 2016
Published decision: Substantially Equivalent

Classification

Product code: PNP

Published parties

Applicant: 3Shape A/S

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2015-06-01
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3630

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.