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FDA 510(k)

BioHorizons CAD/CAM Bars

K-Number: K180998 · 2018-09-28

ApplicantBioHorizons Implant Systems, Inc.
Decision Date2018-09-28
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BioHorizons CAD/CAM Bars is a medical device manufactured by BioHorizons Implant Systems, Inc.. It received FDA 510(k) clearance on 2018-09-28 under approval number K180998. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioHorizons CAD/CAM Bars?

BioHorizons CAD/CAM Bars is a medical device that received FDA 510(k) clearance on 2018-09-28. It is manufactured by BioHorizons Implant Systems, Inc.. The 510(k) number is K180998.

When was BioHorizons CAD/CAM Bars approved by the FDA?

BioHorizons CAD/CAM Bars received FDA 510(k) clearance on 2018-09-28, under approval number K180998.

What company makes BioHorizons CAD/CAM Bars?

BioHorizons CAD/CAM Bars is manufactured by BioHorizons Implant Systems, Inc..

What is the FDA product code for BioHorizons CAD/CAM Bars?

The FDA product code for BioHorizons CAD/CAM Bars is NHA.

Other Devices by BioHorizons Implant Systems, Inc.

K151621BioHorizons CAD/CAM Abutments K172576BioHorizons Tapered Short Implants K182070BioHorizons Tapered IM Implants K203252Multi-unit Abutments for CONELOG K223697MRI compatibility for existing BioHorizons dental implants and abutments K240531SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment

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Related Devices (Code: NHA)

K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd. K160798IPS e.max® Press Abutment Solutions for Viteo Base TiIvoclar Vivadent, AG K162004PREMIUM Implant Systems SHELTA Implant SystemsSweden & Martina S.P.A. K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd. K161435Temporary Snap AbutmentNobel Biocare AB K160786RODO Abutment SystemRodo Medical, Inc.

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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