VistaSoft 4.0 and VisionX 4.0— 510(k) K250947
Substantially EquivalentDurr Dental SE
FDA 510(k) clearance K250947 for VistaSoft 4.0 and VisionX 4.0, Substantially Equivalent on 2025-08-27. Applicant: Durr Dental SE. Device class: 2.
Clearance details
- Applicant
- Durr Dental SE
- Product code
- Code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bietigheim-Bissingen, DE
Recent devices under product code QIH
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