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FDA 510(k)

KATANA Zirconia ONE For IMPLANT

K-Number: K233285 · 2024-05-24

ApplicantKuraray Noritake Dental, Inc.
Decision Date2024-05-24
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KATANA Zirconia ONE For IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2024-05-24 under 510(k) number K233285. 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 KATANA Zirconia ONE For IMPLANT?

KATANA Zirconia ONE For IMPLANT is a medical device that received FDA 510(k) clearance on 2024-05-24. The listed applicant is Kuraray Noritake Dental, Inc.. The 510(k) number is K233285.

When did KATANA Zirconia ONE For IMPLANT receive FDA 510(k) clearance?

KATANA Zirconia ONE For IMPLANT received FDA 510(k) clearance on 2024-05-24, under 510(k) number K233285.

Who is the listed applicant for KATANA Zirconia ONE For IMPLANT?

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

What is the FDA product code for KATANA Zirconia ONE For IMPLANT?

The FDA product code for KATANA Zirconia ONE For IMPLANT is NHA.

Other records listing Kuraray Noritake Dental, Inc. as applicant

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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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