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FDA 510(k)

CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE

K-Number: K122427 · 2012-09-12

ApplicantCarestream Dental, LLC
Decision Date2012-09-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Dental, LLC. It received FDA 510(k) clearance on 2012-09-12 under 510(k) number K122427. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE?

CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE is a medical device that received FDA 510(k) clearance on 2012-09-12. The listed applicant is Carestream Dental, LLC. The 510(k) number is K122427.

When did CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE receive FDA 510(k) clearance?

CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE received FDA 510(k) clearance on 2012-09-12, under 510(k) number K122427.

Who is the listed applicant for CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE?

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

What is the FDA product code for CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE?

The FDA product code for CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE is LLZ.

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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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