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FDA 510(k)

MIS LYNX Conical Connection Implant System

K-Number: K241692 · 2024-11-25

ApplicantDentsply Sirona, Inc.
Decision Date2024-11-25
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MIS LYNX Conical Connection Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona, Inc.. It received FDA 510(k) clearance on 2024-11-25 under 510(k) number K241692. 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 MIS LYNX Conical Connection Implant System?

MIS LYNX Conical Connection Implant System is a medical device that received FDA 510(k) clearance on 2024-11-25. The listed applicant is Dentsply Sirona, Inc.. The 510(k) number is K241692.

When did MIS LYNX Conical Connection Implant System receive FDA 510(k) clearance?

MIS LYNX Conical Connection Implant System received FDA 510(k) clearance on 2024-11-25, under 510(k) number K241692.

Who is the listed applicant for MIS LYNX Conical Connection Implant System?

The FDA 510(k) record lists Dentsply Sirona, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIS LYNX Conical Connection Implant System?

The FDA product code for MIS LYNX Conical Connection Implant System 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.

NCT03528330Clinical, Radiological and Microbiological Outcomes of Implants With Two Different Connection Configurations, a Split-mouth RCT.COMPLETEDNCT05883202Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental ImplantsSUSPENDED

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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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