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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 a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2022-11-16 under approval 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. It is manufactured by Dentsply Sirona. The 510(k) number is K221094.

When was OmniTaper EV Dental Implants, DS Implants abutments with EV connection approved by the FDA?

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

What company makes OmniTaper EV Dental Implants, DS Implants abutments with EV connection?

OmniTaper EV Dental Implants, DS Implants abutments with EV connection is manufactured by Dentsply Sirona.

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

NCT07608523 Marginal Bone Level Around Dental Implants in Periodontitis Patients COMPLETED NCT07605286 Soft Tissue Augmentation Around Dental Implants COMPLETED NCT07589140 Influence of Alveolar Bone Drilling and Anatomical Position on Integration NOT_YET_RECRUITING NCT07246499 Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues. ACTIVE_NOT_RECRUITING NCT07240493 BMP Effect on Implant Stability and Marginal Bone Level After Immediate Placement COMPLETED NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED

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Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K163043Zeramex P6 Dental Implant SystemDentalpoint AG K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech Co., 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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