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FDA 510(k)

VisionX 3.0

K-Number: K213326 · 2021-11-02

ApplicantDurr Dental SE
Decision Date2021-11-02
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VisionX 3.0 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 2021-11-02 under 510(k) number K213326. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VisionX 3.0?

VisionX 3.0 is a medical device that received FDA 510(k) clearance on 2021-11-02. The listed applicant is Durr Dental SE. The 510(k) number is K213326.

When did VisionX 3.0 receive FDA 510(k) clearance?

VisionX 3.0 received FDA 510(k) clearance on 2021-11-02, under 510(k) number K213326.

Who is the listed applicant for VisionX 3.0?

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 VisionX 3.0?

The FDA product code for VisionX 3.0 is LLZ.

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: LLZ)

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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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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