Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MIS Lance+ Conical Connection Dental Implant System

K-Number: K210886 · 2021-06-17

ApplicantDentsply Sirona
Decision Date2021-06-17
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MIS Lance+ Conical Connection Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2021-06-17 under 510(k) number K210886. 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 Lance+ Conical Connection Dental Implant System?

MIS Lance+ Conical Connection Dental Implant System is a medical device that received FDA 510(k) clearance on 2021-06-17. The listed applicant is Dentsply Sirona. The 510(k) number is K210886.

When did MIS Lance+ Conical Connection Dental Implant System receive FDA 510(k) clearance?

MIS Lance+ Conical Connection Dental Implant System received FDA 510(k) clearance on 2021-06-17, under 510(k) number K210886.

Who is the listed applicant for MIS Lance+ Conical Connection Dental Implant System?

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

What is the FDA product code for MIS Lance+ Conical Connection Dental Implant System?

The FDA product code for MIS Lance+ Conical Connection Dental 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 ImplantsSUSPENDEDNCT05122897Investigation of Biofilm Formation on Temporary push-on Rings of Implant CrownsRECRUITINGNCT05859113Evaluation of Marginal Bone Loss and Associated Factors Around Ziacom Dental Implants With Different Prosthetic ConnectionACTIVE_NOT_RECRUITINGNCT07557836Comparative Clinical Study of Implant Stability and Peri-implant Bone Loss in Two Implant DesignsCOMPLETED

Other records listing Dentsply Sirona as applicant

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.

K260785DS Core CBCT AnatomyK260722SureSmile Aligner (ASSY500020)K253565SureSmile SoftwareK251614Stainless Steel Surgical KitsK253959Primevision 3DK253009DS Core Detect

View all 86 devices →

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.

↑