Stratasys TrueDent— 510(k) K220771

Substantially Equivalent

Stratasys, Ltd.

FDA 510(k) clearance K220771 for Stratasys TrueDent, Substantially Equivalent on 2022-07-07. Applicant: Stratasys, Ltd..

Clearance details

Applicant: Stratasys, Ltd.
Product code: Code EBI
Advisory panel: Dental
Date received: 2022-03-16
Decision date: 2022-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rehovot, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.