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FDA 510(k)

Implant-One Multi-Unit Abutment

K-Number: K212394 · 2023-03-23

ApplicantImplant Logistics, Inc.
Decision Date2023-03-23
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Implant-One Multi-Unit Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Implant Logistics, Inc.. It received FDA 510(k) clearance on 2023-03-23 under 510(k) number K212394. 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 Implant-One Multi-Unit Abutment?

Implant-One Multi-Unit Abutment is a medical device that received FDA 510(k) clearance on 2023-03-23. The listed applicant is Implant Logistics, Inc.. The 510(k) number is K212394.

When did Implant-One Multi-Unit Abutment receive FDA 510(k) clearance?

Implant-One Multi-Unit Abutment received FDA 510(k) clearance on 2023-03-23, under 510(k) number K212394.

Who is the listed applicant for Implant-One Multi-Unit Abutment?

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

What is the FDA product code for Implant-One Multi-Unit Abutment?

The FDA product code for Implant-One Multi-Unit Abutment 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.

NCT05883202Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental ImplantsSUSPENDED

Other records listing Implant Logistics, 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.

K231455Implant-One SystemK173701Implant-One 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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