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FDA 510(k)

OmniTaper EV Dental Implants, DS Implants abutments with EV connection

K-Number: K221094 · 2022-11-16

ApplicantDentsply Sirona
Decision Date2022-11-16
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OmniTaper EV Dental Implants, DS Implants abutments with EV connection is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2022-11-16 under 510(k) number K221094. 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 OmniTaper EV Dental Implants, DS Implants abutments with EV connection?

OmniTaper EV Dental Implants, DS Implants abutments with EV connection is a medical device that received FDA 510(k) clearance on 2022-11-16. The listed applicant is Dentsply Sirona. The 510(k) number is K221094.

When did OmniTaper EV Dental Implants, DS Implants abutments with EV connection receive FDA 510(k) clearance?

OmniTaper EV Dental Implants, DS Implants abutments with EV connection received FDA 510(k) clearance on 2022-11-16, under 510(k) number K221094.

Who is the listed applicant for OmniTaper EV Dental Implants, DS Implants abutments with EV connection?

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 OmniTaper EV Dental Implants, DS Implants abutments with EV connection?

The FDA product code for OmniTaper EV Dental Implants, DS Implants abutments with EV connection is DZE.

Related Clinical Trials

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NCT05883202Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental ImplantsSUSPENDEDNCT03528330Clinical, Radiological and Microbiological Outcomes of Implants With Two Different Connection Configurations, a Split-mouth RCT.COMPLETEDNCT05859113Evaluation of Marginal Bone Loss and Associated Factors Around Ziacom Dental Implants With Different Prosthetic ConnectionACTIVE_NOT_RECRUITINGNCT07246499Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues.COMPLETEDNCT07714265Soft Tissue Augmentation Around Dental Implants Using Connective Tissue Graft, Submerged Tenting Abutment, or Sub-crestal Implant PlacementRECRUITING

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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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