FDA · official record K230095Substantially Equivalent

ScanX Swift 2.0, ScanX Swift View 2.0

Name: ScanX Swift 2.0, ScanX Swift View 2.0 — FDA K230095
Creator: Durr Dental SE
Keywords: ScanX Swift 2.0, ScanX Swift View 2.0, ScanX Swift 2.0, ScanX Swift View 2.0, K230095, MUH, FDA

United StatesMUHDurr Dental SE

Verified

Official record identity

FDA application number: K230095
Decision date: February 06, 2023
Published decision: Substantially Equivalent

Classification

Product code: MUH

Published parties

Applicant: Durr Dental SE

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2023-01-12
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.