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FDA 510(k)

DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE

K-Number: K122065 · 2013-02-08

ApplicantOrmco Corp.
Decision Date2013-02-08
Product CodeNOF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE is the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corp.. It received FDA 510(k) clearance on 2013-02-08 under 510(k) number K122065. The device is classified under product code NOF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE?

DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE is a medical device that received FDA 510(k) clearance on 2013-02-08. The listed applicant is Ormco Corp.. The 510(k) number is K122065.

When did DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE receive FDA 510(k) clearance?

DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE received FDA 510(k) clearance on 2013-02-08, under 510(k) number K122065.

Who is the listed applicant for DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE?

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 DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE?

The FDA product code for DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE is NOF.

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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.

K123118INSIGNIA DIGICASTK123416INSIGNIA WITH ITEROK121524INSIGNIAK112640HYPERELASTIC WIREK101676CLEARARCHK081900TEMPORARY TOOTH REPLACEMENT

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Related Devices (Code: NOF)

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.

K1224673M TRUE DEFINITION SCANNER3M CompanyK0819613M UNITEK LAVA CHAIRSIDE ORAL SCANNERBrontes TechnologiesK0731993M ESPE LAVA CHAIRSIDE ORAL SCANNERBrontes Technologies

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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