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FDA 510(k)

Straumann SLActive labeling changes

K-Number: K223083 · 2023-06-22

Decision Date2023-06-22
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann SLActive labeling changes 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 2023-06-22 under 510(k) number K223083. 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 Straumann SLActive labeling changes?

Straumann SLActive labeling changes is a medical device that received FDA 510(k) clearance on 2023-06-22. The listed applicant is Institut Straumann AG. The 510(k) number is K223083.

When did Straumann SLActive labeling changes receive FDA 510(k) clearance?

Straumann SLActive labeling changes received FDA 510(k) clearance on 2023-06-22, under 510(k) number K223083.

Who is the listed applicant for Straumann SLActive labeling changes?

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 SLActive labeling changes?

The FDA product code for Straumann SLActive labeling changes is DZE.

Related Clinical Trials

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.

Other records listing Institut Straumann AG 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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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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.