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FDA 510(k)

ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW

K-Number: K032355 · 2003-09-25

ApplicantDentsply Gendex
Decision Date2003-09-25
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Gendex. It received FDA 510(k) clearance on 2003-09-25 under 510(k) number K032355. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW?

ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW is a medical device that received FDA 510(k) clearance on 2003-09-25. The listed applicant is Dentsply Gendex. The 510(k) number is K032355.

When did ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW receive FDA 510(k) clearance?

ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW received FDA 510(k) clearance on 2003-09-25, under 510(k) number K032355.

Who is the listed applicant for ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW?

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

What is the FDA product code for ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW?

The FDA product code for ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW is EHD.

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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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