FDA · official record K152086Substantially Equivalent

3Shape Ortho System

Name: 3Shape Ortho System — FDA K152086
Creator: 3Shape A/S
Keywords: 3Shape Ortho System, 3Shape Ortho System, K152086, PNN, FDA

United StatesPNN3Shape A/S

Verified

Official record identity

FDA application number: K152086
Decision date: April 28, 2016
Published decision: Substantially Equivalent

Classification

Product code: PNN

Published parties

Applicant: 3Shape A/S

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2015-07-27
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.5470

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.