Ortho System— 510(k) K163677

Substantially Equivalent

3Shape A/S

FDA 510(k) clearance K163677 for Ortho System, Substantially Equivalent on 2017-04-20. Applicant: 3Shape A/S.

Clearance details

Applicant: 3Shape A/S
Product code: Code PNN
Advisory panel: Dental
Date received: 2016-12-27
Decision date: 2017-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Copenhagen, DK

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Data sourced from openFDA. This site is unofficial and independent of the FDA.