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FDA 510(k)

Stratasys TrueDent

K-Number: K220771 · 2022-07-07

ApplicantStratasys, Ltd.
Decision Date2022-07-07
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Stratasys TrueDent is a medical device manufactured by Stratasys, Ltd.. It received FDA 510(k) clearance on 2022-07-07 under approval number K220771. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stratasys TrueDent?

Stratasys TrueDent is a medical device that received FDA 510(k) clearance on 2022-07-07. It is manufactured by Stratasys, Ltd.. The 510(k) number is K220771.

When was Stratasys TrueDent approved by the FDA?

Stratasys TrueDent received FDA 510(k) clearance on 2022-07-07, under approval number K220771.

What company makes Stratasys TrueDent?

Stratasys TrueDent is manufactured by Stratasys, Ltd..

What is the FDA product code for Stratasys TrueDent?

The FDA product code for Stratasys TrueDent is EBI.

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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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