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FDA 510(k)

BioHorizons Tapered IM Implants

K-Number: K182070 · 2018-10-10

ApplicantBioHorizons Implant Systems, Inc.
Decision Date2018-10-10
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BioHorizons Tapered IM Implants is a medical device manufactured by BioHorizons Implant Systems, Inc.. It received FDA 510(k) clearance on 2018-10-10 under approval number K182070. 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 IM Implants?

BioHorizons Tapered IM Implants is a medical device that received FDA 510(k) clearance on 2018-10-10. It is manufactured by BioHorizons Implant Systems, Inc.. The 510(k) number is K182070.

When was BioHorizons Tapered IM Implants approved by the FDA?

BioHorizons Tapered IM Implants received FDA 510(k) clearance on 2018-10-10, under approval number K182070.

What company makes BioHorizons Tapered IM Implants?

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

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

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

Related Clinical Trials

NCT07544706 A Follow-Up Study of Straight and Tapered Dental Implants in the Front Upper Jaw ACTIVE_NOT_RECRUITING

Other Devices by BioHorizons Implant Systems, Inc.

K151621BioHorizons CAD/CAM Abutments K172576BioHorizons Tapered Short 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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