FDA · official record K231055Substantially Equivalent

x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)

Name: x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) — FDA K231055
Creator: De Götzen S.R.L.
Keywords: x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology), x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology), K231055, EHD, FDA

United StatesEHDDe Götzen S.R.L.

Verified

Official record identity

FDA application number: K231055
Decision date: December 28, 2023
Published decision: Substantially Equivalent

Classification

Product code: EHD

Published parties

Applicant: De Götzen S.R.L.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Abbreviated
Received date: 2023-04-13
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.1800

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.