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FDA 510(k)

TruAbutment DS, TruBase

K-Number: K213961 · 2022-07-14

ApplicantTruabutment, Inc.
Decision Date2022-07-14
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TruAbutment DS, TruBase is the device name listed in this FDA 510(k) record. The listed applicant is Truabutment, Inc.. It received FDA 510(k) clearance on 2022-07-14 under 510(k) number K213961. 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 TruAbutment DS, TruBase?

TruAbutment DS, TruBase is a medical device that received FDA 510(k) clearance on 2022-07-14. The listed applicant is Truabutment, Inc.. The 510(k) number is K213961.

When did TruAbutment DS, TruBase receive FDA 510(k) clearance?

TruAbutment DS, TruBase received FDA 510(k) clearance on 2022-07-14, under 510(k) number K213961.

Who is the listed applicant for TruAbutment DS, TruBase?

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

What is the FDA product code for TruAbutment DS, TruBase?

The FDA product code for TruAbutment DS, TruBase is NHA.

Other records listing Truabutment, 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.

K243255URIS Long Implant & AbutmentsK241485TruAbutment DS; TruBaseK230438URIS Smart Path Implant System & ProstheticK231874AOT & T-L AbutmentK203649TruAbutment DS, TruBaseK202579TruAbutment DS, TruBase

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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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