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FDA 510(k)

CamX Triton HD Proxi Head

K-Number: K172007 · 2017-11-22

ApplicantDuerr Dental AG
Decision Date2017-11-22
Product CodeNTK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CamX Triton HD Proxi Head 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 2017-11-22 under 510(k) number K172007. The device is classified under product code NTK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CamX Triton HD Proxi Head?

CamX Triton HD Proxi Head is a medical device that received FDA 510(k) clearance on 2017-11-22. The listed applicant is Duerr Dental AG. The 510(k) number is K172007.

When did CamX Triton HD Proxi Head receive FDA 510(k) clearance?

CamX Triton HD Proxi Head received FDA 510(k) clearance on 2017-11-22, under 510(k) number K172007.

Who is the listed applicant for CamX Triton HD Proxi Head?

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 CamX Triton HD Proxi Head?

The FDA product code for CamX Triton HD Proxi Head is NTK.

Other records listing Duerr Dental AG 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.

K170733ScanX Intraoral ViewK161444DBSWIN and VistaEasy Imaging Software

Related Devices (Code: NTK)

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.

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