KATANA ZIRCONIA

K131534 · Kuraray Noritake Dental, Inc. · EIH · Oct 11, 2013 · Dental

Device Facts

• Record ID: K131534
• Device Name: KATANA ZIRCONIA
• Applicant: Kuraray Noritake Dental, Inc.
• Product Code: EIH · Dental
• Decision Date: Oct 11, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

KATANA Zirconia is used for fabricating the all-ceramic dental frameworks or FCZ crowns and bridges. This disc (or block) is designed to provide patients with strong and tough prosthetic dental restorations for anterior and posterior applications.

Device Story

KATANA Zirconia is a dental ceramic material supplied as discs or blocks. Used by dental professionals to fabricate all-ceramic frameworks, crowns, and bridges. Material is milled to create prosthetic restorations for anterior and posterior applications. Provides high strength and toughness for dental reconstruction. Device is a restorative material; no software or automated processing involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Zirconia-based ceramic material. Supplied as discs or blocks for CAD/CAM milling. Intended for anterior and posterior dental restorations. Class II device (Product Code: EIH).

Indications for Use

Indicated for patients requiring all-ceramic dental frameworks or full-contour zirconia (FCZ) crowns and bridges for anterior and posterior prosthetic restorations.

Regulatory Classification

Identification

Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hamnshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

## October 11, 2013

Kuraray Noritake Dental, Inc. C/O Mr. Ivan J. Wasserman Counsel Manatt, Phelps, & Philips, LLP 700 12th Street NW, Suite 1100 Washington, DC 20005

Re: K131534

Trade/Device Name: KATANA Zirconia Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: July 22, 2013 Received: July 25, 2013

Dear Mr. Wasserman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mary's Runner -S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K131534

## Indications for Use

510(k) Number (if known):

Device Name: KATANA Zirconia

Indications for Use:

KATANA Zirconia is used for fabricating the all-ceramic dental frameworks or FCZ crowns and bridges.

This disc (or block) is designed to provide patients with strong and tough prosthetic dental restorations for anterior and posterior applications.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ N/A (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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