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FDA 510(k)

VistaSoft 4.0 and VisionX 4.0

K-Number: K250947 · 2025-08-27

ApplicantDurr Dental SE
Decision Date2025-08-27
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VistaSoft 4.0 and VisionX 4.0 is the device name listed in this FDA 510(k) record. The listed applicant is Durr Dental SE. It received FDA 510(k) clearance on 2025-08-27 under 510(k) number K250947. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VistaSoft 4.0 and VisionX 4.0?

VistaSoft 4.0 and VisionX 4.0 is a medical device that received FDA 510(k) clearance on 2025-08-27. The listed applicant is Durr Dental SE. The 510(k) number is K250947.

When did VistaSoft 4.0 and VisionX 4.0 receive FDA 510(k) clearance?

VistaSoft 4.0 and VisionX 4.0 received FDA 510(k) clearance on 2025-08-27, under 510(k) number K250947.

Who is the listed applicant for VistaSoft 4.0 and VisionX 4.0?

The FDA 510(k) record lists Durr Dental SE as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VistaSoft 4.0 and VisionX 4.0?

The FDA product code for VistaSoft 4.0 and VisionX 4.0 is QIH.

Other records listing Durr Dental SE as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: QIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253794Prostate CoreLucida Medical, Ltd.K252571mdprostateMediaire GmbHK253902RealGUIDE3DIEMME SRLK253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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