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FDA 510(k)

PrimeTaper EV Dental Implant

K-Number: K210610 · 2021-08-27

ApplicantDentsply Sirona, Inc.
Decision Date2021-08-27
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PrimeTaper EV Dental Implant is a medical device manufactured by Dentsply Sirona, Inc.. It received FDA 510(k) clearance on 2021-08-27 under approval number K210610. 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 PrimeTaper EV Dental Implant?

PrimeTaper EV Dental Implant is a medical device that received FDA 510(k) clearance on 2021-08-27. It is manufactured by Dentsply Sirona, Inc.. The 510(k) number is K210610.

When was PrimeTaper EV Dental Implant approved by the FDA?

PrimeTaper EV Dental Implant received FDA 510(k) clearance on 2021-08-27, under approval number K210610.

What company makes PrimeTaper EV Dental Implant?

PrimeTaper EV Dental Implant is manufactured by Dentsply Sirona, Inc..

What is the FDA product code for PrimeTaper EV Dental Implant?

The FDA product code for PrimeTaper EV Dental Implant is DZE.

Related Clinical Trials

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 NCT07580495 Effect of Collagen Membrane on Ridge Preservation NOT_YET_RECRUITING

Other Devices by Dentsply Sirona, Inc.

K192149MIS Dental Implant System K183079Conometric Abutments K193064Atlantis suprastructures K212281Surgical Trays K230199Byte Aligner System K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment System

View all 21 devices →

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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