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FDA 510(k)

CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS

K-Number: K122295 · 2013-10-24

ApplicantCore 3D Protech, S.L.
Decision Date2013-10-24
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS is the device name listed in this FDA 510(k) record. The listed applicant is Core 3D Protech, S.L.. It received FDA 510(k) clearance on 2013-10-24 under 510(k) number K122295. 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 CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS?

CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS is a medical device that received FDA 510(k) clearance on 2013-10-24. The listed applicant is Core 3D Protech, S.L.. The 510(k) number is K122295.

When did CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS receive FDA 510(k) clearance?

CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS received FDA 510(k) clearance on 2013-10-24, under 510(k) number K122295.

Who is the listed applicant for CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS?

The FDA 510(k) record lists Core 3D Protech, S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS?

The FDA product code for CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS is NHA.

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Related Devices (Code: NHA)

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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