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FDA 510(k)

Ortho System

K-Number: K163677 · 2017-04-20

Applicant3Shape A/S
Decision Date2017-04-20
Product CodePNN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Ortho System is a medical device manufactured by 3Shape A/S. It received FDA 510(k) clearance on 2017-04-20 under approval number K163677. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ortho System?

Ortho System is a medical device that received FDA 510(k) clearance on 2017-04-20. It is manufactured by 3Shape A/S. The 510(k) number is K163677.

When was Ortho System approved by the FDA?

Ortho System received FDA 510(k) clearance on 2017-04-20, under approval number K163677.

What company makes Ortho System?

Ortho System is manufactured by 3Shape A/S.

What is the FDA product code for Ortho System?

The FDA product code for Ortho System is PNN.

Other Devices by 3Shape A/S

K1514553Shape Abutment Designer Software K1520863Shape Ortho System K161884Ortho System K180941Ortho System K171634Ortho System K1919113Shape Splint Design

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Related Devices (Code: PNN)

K1520863Shape Ortho System3Shape A/S K162850GuideMia Ortho+Guidemia Technologies, LLC K181112Orchestrate 3DOrchestrate 3D K180941Ortho System3Shape A/S K171634Ortho System3Shape A/S K171122CEREC Ortho SoftwareDentsply Sirona

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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