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FDA 510(k)

3Shape Ortho System

K-Number: K152086 · 2016-04-28

Applicant3Shape A/S
Decision Date2016-04-28
Product CodePNN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3Shape Ortho System is a medical device manufactured by 3Shape A/S. It received FDA 510(k) clearance on 2016-04-28 under approval number K152086. 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 3Shape Ortho System?

3Shape Ortho System is a medical device that received FDA 510(k) clearance on 2016-04-28. It is manufactured by 3Shape A/S. The 510(k) number is K152086.

When was 3Shape Ortho System approved by the FDA?

3Shape Ortho System received FDA 510(k) clearance on 2016-04-28, under approval number K152086.

What company makes 3Shape Ortho System?

3Shape Ortho System is manufactured by 3Shape A/S.

What is the FDA product code for 3Shape Ortho System?

The FDA product code for 3Shape Ortho System is PNN.

Other Devices by 3Shape A/S

K1514553Shape Abutment Designer Software K163677Ortho System K161884Ortho System K180941Ortho System K171634Ortho System K1919113Shape Splint Design

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Related Devices (Code: PNN)

K163677Ortho 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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