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FDA 510(k)

IU Implant System Abutment

K-Number: K221969 · 2023-05-12

ApplicantWarantec Co., Ltd.
Decision Date2023-05-12
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IU Implant System Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Warantec Co., Ltd.. It received FDA 510(k) clearance on 2023-05-12 under 510(k) number K221969. 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 IU Implant System Abutment?

IU Implant System Abutment is a medical device that received FDA 510(k) clearance on 2023-05-12. The listed applicant is Warantec Co., Ltd.. The 510(k) number is K221969.

When did IU Implant System Abutment receive FDA 510(k) clearance?

IU Implant System Abutment received FDA 510(k) clearance on 2023-05-12, under 510(k) number K221969.

Who is the listed applicant for IU Implant System Abutment?

The FDA 510(k) record lists Warantec Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IU Implant System Abutment?

The FDA product code for IU Implant System Abutment is NHA.

Other records listing Warantec Co., Ltd. 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.

K221972Warantec Custom AbutmentK172345IU 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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