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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 the device name listed in this FDA 510(k) record. The listed applicant is BioHorizons Implant Systems, Inc.. It received FDA 510(k) clearance on 2024-07-30 under 510(k) 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. The listed applicant is BioHorizons Implant Systems, Inc.. The 510(k) number is K240531.

When did SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment receive FDA 510(k) clearance?

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

Who is the listed applicant for SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment?

The FDA 510(k) record lists BioHorizons Implant Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing BioHorizons Implant Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260061BioHorizons CEREC Compatible Ti-BasesK243521Conical Ti Base abutmentsK240187Tapered Pro Conical Implant SystemK223697MRI compatibility for existing BioHorizons dental implants and abutmentsK203252Multi-unit Abutments for CONELOGK182070BioHorizons Tapered IM Implants

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Related Devices (Code: NHA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC

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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