ScanX Swift 2.0, ScanX Swift View 2.0— 510(k) K230095

Substantially Equivalent

Durr Dental SE

FDA 510(k) clearance K230095 for ScanX Swift 2.0, ScanX Swift View 2.0, Substantially Equivalent on 2023-02-06. Applicant: Durr Dental SE. Device class: 2.

Clearance details

Applicant
Durr Dental SE
Product code
Code MUH
Device class
Class 2
Regulation
21 CFR 872.1800
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Bietigheim-Bissingen, DE
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Data sourced from openFDA. This site is unofficial and independent of the FDA.