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FDA 510(k)

Straumann® RidgeFit Implants

K-Number: K250294 · 2025-08-12

ApplicantInstitut Straumann AG
Decision Date2025-08-12
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann® RidgeFit Implants 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 2025-08-12 under 510(k) number K250294. 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® RidgeFit Implants?

Straumann® RidgeFit Implants is a medical device that received FDA 510(k) clearance on 2025-08-12. The listed applicant is Institut Straumann AG. The 510(k) number is K250294.

When did Straumann® RidgeFit Implants receive FDA 510(k) clearance?

Straumann® RidgeFit Implants received FDA 510(k) clearance on 2025-08-12, under 510(k) number K250294.

Who is the listed applicant for Straumann® RidgeFit Implants?

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® RidgeFit Implants?

The FDA product code for Straumann® RidgeFit Implants 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.

NCT04741594Osseodensification and Implant Survival and SuccessCOMPLETEDNCT06086873Investigating Implant Surface Effect on Osseointegration: NGA vs. ModSLARECRUITING

Other records listing Institut Straumann AG as applicant

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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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