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FDA 510(k)

INSIGNIA DIGICAST

K-Number: K123118 · 2013-03-26

ApplicantOrmco Corp.
Decision Date2013-03-26
Product CodeDYW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INSIGNIA DIGICAST is the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corp.. It received FDA 510(k) clearance on 2013-03-26 under 510(k) number K123118. The device is classified under product code DYW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSIGNIA DIGICAST?

INSIGNIA DIGICAST is a medical device that received FDA 510(k) clearance on 2013-03-26. The listed applicant is Ormco Corp.. The 510(k) number is K123118.

When did INSIGNIA DIGICAST receive FDA 510(k) clearance?

INSIGNIA DIGICAST received FDA 510(k) clearance on 2013-03-26, under 510(k) number K123118.

Who is the listed applicant for INSIGNIA DIGICAST?

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

What is the FDA product code for INSIGNIA DIGICAST?

The FDA product code for INSIGNIA DIGICAST is DYW.

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Other records listing Ormco Corp. 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.

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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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