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FDA 510(k)

LOCATOR R-Tx

K-Number: K200827 · 2020-09-02

ApplicantIvory Super Holdco, Incp.
Decision Date2020-09-02
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LOCATOR R-Tx is the device name listed in this FDA 510(k) record. The listed applicant is Ivory Super Holdco, Incp.. It received FDA 510(k) clearance on 2020-09-02 under 510(k) number K200827. 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 LOCATOR R-Tx?

LOCATOR R-Tx is a medical device that received FDA 510(k) clearance on 2020-09-02. The listed applicant is Ivory Super Holdco, Incp.. The 510(k) number is K200827.

When did LOCATOR R-Tx receive FDA 510(k) clearance?

LOCATOR R-Tx received FDA 510(k) clearance on 2020-09-02, under 510(k) number K200827.

Who is the listed applicant for LOCATOR R-Tx?

The FDA 510(k) record lists Ivory Super Holdco, Incp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOCATOR R-Tx?

The FDA product code for LOCATOR R-Tx is NHA.

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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