FDA 510(k)

DBSWIN, VISTAEASY

K-Number: K203287 · 2020-11-18

Decision Date2020-11-18

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DBSWIN, VISTAEASY is the device name listed in this FDA 510(k) record. The listed applicant is Dürr Dental SE. It received FDA 510(k) clearance on 2020-11-18 under 510(k) number K203287. 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 DBSWIN, VISTAEASY?

DBSWIN, VISTAEASY is a medical device that received FDA 510(k) clearance on 2020-11-18. The listed applicant is Dürr Dental SE. The 510(k) number is K203287.

When did DBSWIN, VISTAEASY receive FDA 510(k) clearance?

DBSWIN, VISTAEASY received FDA 510(k) clearance on 2020-11-18, under 510(k) number K203287.

Who is the listed applicant for DBSWIN, VISTAEASY?

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

What is the FDA product code for DBSWIN, VISTAEASY?

The FDA product code for DBSWIN, VISTAEASY is LLZ.

Other records listing Dürr 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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Official Source

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