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FDA 510(k)

Straumann Variobase for Crown AS

K-Number: K173379 · 2018-03-30

ApplicantInstitut Straumann AG
Decision Date2018-03-30
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann Variobase for Crown AS is the device name listed in this FDA 510(k) record. The listed applicant is Institut Straumann AG. It received FDA 510(k) clearance on 2018-03-30 under 510(k) number K173379. 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 Straumann Variobase for Crown AS?

Straumann Variobase for Crown AS is a medical device that received FDA 510(k) clearance on 2018-03-30. The listed applicant is Institut Straumann AG. The 510(k) number is K173379.

When did Straumann Variobase for Crown AS receive FDA 510(k) clearance?

Straumann Variobase for Crown AS received FDA 510(k) clearance on 2018-03-30, under 510(k) number K173379.

Who is the listed applicant for Straumann Variobase for Crown AS?

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

What is the FDA product code for Straumann Variobase for Crown AS?

The FDA product code for Straumann Variobase for Crown AS is NHA.

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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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