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 a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2025-08-12 under approval 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. It is manufactured by Institut Straumann AG. The 510(k) number is K250294.
When was Straumann® RidgeFit Implants approved by the FDA?
Straumann® RidgeFit Implants received FDA 510(k) clearance on 2025-08-12, under approval number K250294.
What company makes Straumann® RidgeFit Implants?
Straumann® RidgeFit Implants is manufactured by Institut Straumann AG.
What is the FDA product code for Straumann® RidgeFit Implants?
The FDA product code for Straumann® RidgeFit Implants is DZE.
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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.