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FDA 510(k)

Abutment Design

K-Number: K200100 · 2020-10-07

Applicant3Shape A/S
Decision Date2020-10-07
Product CodePNP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Abutment Design is a medical device manufactured by 3Shape A/S. It received FDA 510(k) clearance on 2020-10-07 under approval number K200100. The device is classified under product code PNP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Abutment Design?

Abutment Design is a medical device that received FDA 510(k) clearance on 2020-10-07. It is manufactured by 3Shape A/S. The 510(k) number is K200100.

When was Abutment Design approved by the FDA?

Abutment Design received FDA 510(k) clearance on 2020-10-07, under approval number K200100.

What company makes Abutment Design?

Abutment Design is manufactured by 3Shape A/S.

What is the FDA product code for Abutment Design?

The FDA product code for Abutment Design is PNP.

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Official Source

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