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FDA 510(k)

Straumann® BLC and TLC Implants - Line extension

K-Number: K234049 · 2024-03-20

ApplicantInstitut Straumann AG
Decision Date2024-03-20
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann® BLC and TLC Implants - Line extension is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2024-03-20 under approval number K234049. 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® BLC and TLC Implants - Line extension?

Straumann® BLC and TLC Implants - Line extension is a medical device that received FDA 510(k) clearance on 2024-03-20. It is manufactured by Institut Straumann AG. The 510(k) number is K234049.

When was Straumann® BLC and TLC Implants - Line extension approved by the FDA?

Straumann® BLC and TLC Implants - Line extension received FDA 510(k) clearance on 2024-03-20, under approval number K234049.

What company makes Straumann® BLC and TLC Implants - Line extension?

Straumann® BLC and TLC Implants - Line extension is manufactured by Institut Straumann AG.

What is the FDA product code for Straumann® BLC and TLC Implants - Line extension?

The FDA product code for Straumann® BLC and TLC Implants - Line extension is DZE.

Related Clinical Trials

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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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