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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 a medical device manufactured by Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2024-05-24 under approval 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. It is manufactured by Kuraray Noritake Dental, Inc.. The 510(k) number is K233285.

When was KATANA Zirconia ONE For IMPLANT approved by the FDA?

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

What company makes KATANA Zirconia ONE For IMPLANT?

KATANA Zirconia ONE For IMPLANT is manufactured by Kuraray Noritake Dental, Inc..

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

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

Related Clinical Trials

NCT06012071 Two-piece Zirconia Implants With Two Various Platforms RECRUITING NCT01974362 Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior RECRUITING NCT03908177 Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national RCT. COMPLETED NCT04695899 Zirconia Implants for Replacement of a Single Tooth ACTIVE_NOT_RECRUITING NCT07522671 Clinical Performance of 3D-Printed Resin and Zirconia Implant Restorations RECRUITING

Other Devices by Kuraray Noritake Dental, Inc.

K161042CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack K153476KATANA AVENCIA Block K170834CERABIEN ZR K170986KATANA Zirconia Block K191980CLEARFIL MAJESTY ES Flow K191133KATANA Cleaner, KATANA Cleaner (Trial)

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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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