KATANA Zirconia ONE For IMPLANT

Q: What is the product code of K233285?

The FDA product code is NHA – Abutment, Implant, Dental, Endosseous, a Class II (moderate risk) device regulated under 21 CFR 872.3630.

FDA 510(k) K233285 · Kuraray Noritake Dental, Inc.

Substantially Equivalent

510(k) numberK233285

Submission

Device name: KATANA Zirconia ONE For IMPLANT
Applicant: Kuraray Noritake Dental, Inc.
Chiyoda-Ku, JP
Received: September 29, 2023
Decision date: May 24, 2024
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: NHA – Abutment, Implant, Dental, Endosseous
Device class: Class II (moderate risk)
Regulation: 21 CFR 872.3630
Specialty: Dental
Implant: Yes

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

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Questions and answers

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

KATANA Zirconia ONE For IMPLANT (K233285) received a 510(k) decision of Substantially Equivalent on May 24, 2024, 238 days after the submission was received.

What is the product code of K233285?

The FDA product code is NHA – Abutment, Implant, Dental, Endosseous, a Class II (moderate risk) device regulated under 21 CFR 872.3630.