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FDA 510(k)

BioHorizons Tapered Short Implants

K-Number: K172576 · 2017-11-22

ApplicantBioHorizons Implant Systems, Inc.
Decision Date2017-11-22
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BioHorizons Tapered Short Implants is a medical device manufactured by BioHorizons Implant Systems, Inc.. It received FDA 510(k) clearance on 2017-11-22 under approval number K172576. 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 BioHorizons Tapered Short Implants?

BioHorizons Tapered Short Implants is a medical device that received FDA 510(k) clearance on 2017-11-22. It is manufactured by BioHorizons Implant Systems, Inc.. The 510(k) number is K172576.

When was BioHorizons Tapered Short Implants approved by the FDA?

BioHorizons Tapered Short Implants received FDA 510(k) clearance on 2017-11-22, under approval number K172576.

What company makes BioHorizons Tapered Short Implants?

BioHorizons Tapered Short Implants is manufactured by BioHorizons Implant Systems, Inc..

What is the FDA product code for BioHorizons Tapered Short Implants?

The FDA product code for BioHorizons Tapered Short Implants is DZE.

Related Clinical Trials

NCT07498556 Immediate Restoration of a New Implant With High Primary Stability NOT_YET_RECRUITING NCT03908177 Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national RCT. COMPLETED NCT05876143 Ambispective Multicentric Study Evaluating UKA With U-Knee/Uni-Kroma Implants RECRUITING NCT07544706 A Follow-Up Study of Straight and Tapered Dental Implants in the Front Upper Jaw ACTIVE_NOT_RECRUITING NCT06355713 Improvement of Symptoms After Removal of the Essure® Contraceptive Implant RECRUITING NCT06849856 Evaluation of the Efficacy of Different Non-Surgical Peri-implantitis Treatment Approaches COMPLETED

Other Devices by BioHorizons Implant Systems, Inc.

K151621BioHorizons CAD/CAM Abutments K182070BioHorizons Tapered IM Implants K180998BioHorizons CAD/CAM Bars K203252Multi-unit Abutments for CONELOG K223697MRI compatibility for existing BioHorizons dental implants and abutments K240531SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment

View all 9 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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