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FDA 510(k)

Straumann® PURE Ceramic Implants

K-Number: K241391 · 2024-12-10

ApplicantInstitut Straumann AG
Decision Date2024-12-10
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann® PURE Ceramic Implants is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2024-12-10 under approval number K241391. 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® PURE Ceramic Implants?

Straumann® PURE Ceramic Implants is a medical device that received FDA 510(k) clearance on 2024-12-10. It is manufactured by Institut Straumann AG. The 510(k) number is K241391.

When was Straumann® PURE Ceramic Implants approved by the FDA?

Straumann® PURE Ceramic Implants received FDA 510(k) clearance on 2024-12-10, under approval number K241391.

What company makes Straumann® PURE Ceramic Implants?

Straumann® PURE Ceramic Implants is manufactured by Institut Straumann AG.

What is the FDA product code for Straumann® PURE Ceramic Implants?

The FDA product code for Straumann® PURE Ceramic Implants is DZE.

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Related Devices (Code: 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.

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