FDA 510(k)

Stratasys TrueDent

K-Number: K220771 · 2022-07-07

Decision Date2022-07-07

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Stratasys TrueDent is the device name listed in this FDA 510(k) record. The listed applicant is Stratasys, Ltd.. It received FDA 510(k) clearance on 2022-07-07 under 510(k) 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. The listed applicant is Stratasys, Ltd.. The 510(k) number is K220771.

When did Stratasys TrueDent receive FDA 510(k) clearance?

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

Who is the listed applicant for Stratasys TrueDent?

The FDA 510(k) record lists Stratasys, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stratasys TrueDent?

The FDA product code for Stratasys TrueDent is EBI.

Related Devices (Code: EBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.K260376Denture BaseShandong Huge Dental Material Corporation

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.