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FDA 510(k)

FAICO Dental Implant System and CAD/CAM Abutments

K-Number: K211871 · 2021-11-18

ApplicantFaico Medical, LLC
Decision Date2021-11-18
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FAICO Dental Implant System and CAD/CAM Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Faico Medical, LLC. It received FDA 510(k) clearance on 2021-11-18 under 510(k) number K211871. 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 FAICO Dental Implant System and CAD/CAM Abutments?

FAICO Dental Implant System and CAD/CAM Abutments is a medical device that received FDA 510(k) clearance on 2021-11-18. The listed applicant is Faico Medical, LLC. The 510(k) number is K211871.

When did FAICO Dental Implant System and CAD/CAM Abutments receive FDA 510(k) clearance?

FAICO Dental Implant System and CAD/CAM Abutments received FDA 510(k) clearance on 2021-11-18, under 510(k) number K211871.

Who is the listed applicant for FAICO Dental Implant System and CAD/CAM Abutments?

The FDA 510(k) record lists Faico Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FAICO Dental Implant System and CAD/CAM Abutments?

The FDA product code for FAICO Dental Implant System and CAD/CAM Abutments is NHA.

Related Clinical Trials

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.

NCT01974362Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation BehaviorRECRUITINGNCT05122897Investigation of Biofilm Formation on Temporary push-on Rings of Implant CrownsRECRUITINGNCT05883202Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental ImplantsSUSPENDEDNCT06529601Comparison Between CAD/CAM and Conventional Mandibular Fixed Retainers.RECRUITINGNCT07246499Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues.COMPLETEDNCT07562607Clinical Evaluation of AI-Generated Dental CrownsACTIVE_NOT_RECRUITING

Other records listing Faico Medical, LLC 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.

K191997FAICO CMF SystemK192015Faico Dental Implant System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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