StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2— 510(k) K212103

Name: FDA 510(k) clearance K212103
Creator: U.S. Food and Drug Administration
Published: 2021-08-30

Substantially Equivalent

Fona S.R.L

FDA 510(k) clearance K212103 for StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2, Substantially Equivalent on 2021-08-30. Applicant: Fona S.R.L. Device class: 2.

Clearance details

Applicant: Fona S.R.L
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2021-07-06
Decision date: 2021-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Assago, IT

Download summary PDF View on FDA.gov ↗

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