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FDA 510(k)

ScanX Intraoral View

K-Number: K170733 · 2017-05-01

ApplicantDuerr Dental AG
Decision Date2017-05-01
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ScanX Intraoral View is the device name listed in this FDA 510(k) record. The listed applicant is Duerr Dental AG. It received FDA 510(k) clearance on 2017-05-01 under 510(k) number K170733. 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 Intraoral View?

ScanX Intraoral View is a medical device that received FDA 510(k) clearance on 2017-05-01. The listed applicant is Duerr Dental AG. The 510(k) number is K170733.

When did ScanX Intraoral View receive FDA 510(k) clearance?

ScanX Intraoral View received FDA 510(k) clearance on 2017-05-01, under 510(k) number K170733.

Who is the listed applicant for ScanX Intraoral View?

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

What is the FDA product code for ScanX Intraoral View?

The FDA product code for ScanX Intraoral View is MUH.

Other records listing Duerr Dental AG as applicant

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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.

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