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FDA 510(k)

ITERO SOFTWARE

K-Number: K131101 · 2013-08-26

ApplicantCadent, Ltd. an Align Technology Company
Decision Date2013-08-26
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ITERO SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Cadent, Ltd. an Align Technology Company. It received FDA 510(k) clearance on 2013-08-26 under 510(k) number K131101. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ITERO SOFTWARE?

ITERO SOFTWARE is a medical device that received FDA 510(k) clearance on 2013-08-26. The listed applicant is Cadent, Ltd. an Align Technology Company. The 510(k) number is K131101.

When did ITERO SOFTWARE receive FDA 510(k) clearance?

ITERO SOFTWARE received FDA 510(k) clearance on 2013-08-26, under 510(k) number K131101.

Who is the listed applicant for ITERO SOFTWARE?

The FDA 510(k) record lists Cadent, Ltd. an Align Technology Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ITERO SOFTWARE?

The FDA product code for ITERO SOFTWARE is NHA.

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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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