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FDA 510(k)

KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0

K-Number: K043104 · 2005-02-24

ApplicantPracticeworks, Inc.
Decision Date2005-02-24
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0 is the device name listed in this FDA 510(k) record. The listed applicant is Practiceworks, Inc.. It received FDA 510(k) clearance on 2005-02-24 under 510(k) number K043104. 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 KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0?

KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0 is a medical device that received FDA 510(k) clearance on 2005-02-24. The listed applicant is Practiceworks, Inc.. The 510(k) number is K043104.

When did KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0 receive FDA 510(k) clearance?

KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0 received FDA 510(k) clearance on 2005-02-24, under 510(k) number K043104.

Who is the listed applicant for KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0?

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

What is the FDA product code for KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0?

The FDA product code for KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0 is EHD.

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Official Source

View on FDA Database →

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

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