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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 the device name listed in this FDA 510(k) record. The listed applicant is Institut Straumann AG. It received FDA 510(k) clearance on 2024-03-20 under 510(k) 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. The listed applicant is Institut Straumann AG. The 510(k) number is K234049.

When did Straumann® BLC and TLC Implants - Line extension receive FDA 510(k) clearance?

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

Who is the listed applicant for Straumann® BLC and TLC Implants - Line extension?

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® BLC and TLC Implants - Line extension?

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

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.

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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