FDA 510(k)

ScanX Edge

K-Number: K202633 · 2020-10-07

Decision Date2020-10-07

Product CodeMUH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ScanX Edge 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 2020-10-07 under 510(k) number K202633. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ScanX Edge?

ScanX Edge is a medical device that received FDA 510(k) clearance on 2020-10-07. The listed applicant is Dürr Dental SE. The 510(k) number is K202633.

When did ScanX Edge receive FDA 510(k) clearance?

ScanX Edge received FDA 510(k) clearance on 2020-10-07, under 510(k) number K202633.

Who is the listed applicant for ScanX Edge?

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 ScanX Edge?

The FDA product code for ScanX Edge is MUH.

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.

K203287DBSWIN, VISTAEASY

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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.