Stela Automix System— 510(k) K222581

Substantially Equivalent

Sdi Limited

FDA 510(k) clearance K222581 for Stela Automix System, Substantially Equivalent on 2022-10-28. Applicant: Sdi Limited.

Clearance details

Applicant: Sdi Limited
Product code: Code EBF
Advisory panel: Dental
Date received: 2022-08-26
Decision date: 2022-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, AU

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