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FDA 510(k)

SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment

K-Number: K240531 · 2024-07-30

ApplicantBioHorizons Implant Systems, Inc.
Decision Date2024-07-30
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment is a medical device manufactured by BioHorizons Implant Systems, Inc.. It received FDA 510(k) clearance on 2024-07-30 under approval number K240531. 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 SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment?

SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment is a medical device that received FDA 510(k) clearance on 2024-07-30. It is manufactured by BioHorizons Implant Systems, Inc.. The 510(k) number is K240531.

When was SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment approved by the FDA?

SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment received FDA 510(k) clearance on 2024-07-30, under approval number K240531.

What company makes SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment?

SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment is manufactured by BioHorizons Implant Systems, Inc..

What is the FDA product code for SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment?

The FDA product code for SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment is NHA.

Related Clinical Trials

NCT07246499 Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues. ACTIVE_NOT_RECRUITING NCT07501754 Use of a Custom-Made Acrylic Palatal Stent to Minimize Donor Site Morbidity After Suture-Free Epithelialized Gingival Graft Harvesting: A Randomized Clinical Trial COMPLETED NCT06636136 Transtibial Osseointegration RECRUITING

Other Devices by BioHorizons Implant Systems, Inc.

K151621BioHorizons CAD/CAM Abutments K172576BioHorizons Tapered Short Implants K182070BioHorizons Tapered IM Implants K180998BioHorizons CAD/CAM Bars K203252Multi-unit Abutments for CONELOG K223697MRI compatibility for existing BioHorizons dental implants and abutments

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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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