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FDA 510(k)

NobelZygoma 0°

K-Number: K161598 · 2017-03-14

ApplicantNobel Biocare AB
Decision Date2017-03-14
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NobelZygoma 0° is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare AB. It received FDA 510(k) clearance on 2017-03-14 under 510(k) number K161598. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NobelZygoma 0°?

NobelZygoma 0° is a medical device that received FDA 510(k) clearance on 2017-03-14. The listed applicant is Nobel Biocare AB. The 510(k) number is K161598.

When did NobelZygoma 0° receive FDA 510(k) clearance?

NobelZygoma 0° received FDA 510(k) clearance on 2017-03-14, under 510(k) number K161598.

Who is the listed applicant for NobelZygoma 0°?

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

What is the FDA product code for NobelZygoma 0°?

The FDA product code for NobelZygoma 0° is DZE.

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Related Devices (Code: DZE)

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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