KATANA ZIRCONIA

K050160 · Noritake Co., Inc. · EIH · Feb 7, 2005 · Dental

Device Facts

• Record ID: K050160
• Device Name: KATANA ZIRCONIA
• Applicant: Noritake Co., Inc.
• Product Code: EIH · Dental
• Decision Date: Feb 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

KATANA Zirconia is intended for CAD/CAM fabrication of zirconia frameworks for allceramic dental restorations.

Device Story

KATANA Zirconia is a dental material used for the fabrication of zirconia frameworks for all-ceramic dental restorations. The device is processed via CAD/CAM systems in a dental laboratory or clinical setting. It serves as a restorative material for dental professionals to create crowns, bridges, or other prosthetic frameworks. The material provides structural support for the final ceramic restoration, benefiting patients by offering a durable, biocompatible solution for tooth replacement or repair.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Zirconia-based material for dental restorations. Classified as porcelain powder for clinical use (21 CFR 872.6660). Intended for use with CAD/CAM fabrication systems.

Indications for Use

Indicated for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations in patients requiring dental prosthetics.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 7 2005

Noritake Company, Incorporated C/O Mr. Ivan J. Wasserman, Counsel Collier Shannon Scott, PLLC Washington Harbour, Suite 400 3050 K Street NW Washington, District of Columbia 20007

Re: K050160

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: January 24, 2005 Received: January 25, 2005

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Ivan J. Wasserman, Esq.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 's Issualice of a substance equires with other requirements of the Act or that FDA has made a determination inal your device real sencies. You must comply with any Federal statures and regulations administered by out registrations and listing (21 CFR Part 807);
all the Act's requirements, including, but not limited to: get forth in all the Act's requirements, including, but normance to: requirements as set forth in the quality
labeling (21 CFR Part 801); good manufacturing practice requirements as set f labeling (21 CFR Part 801), good manufacturing production the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic produc systems (QS) regulation (2) -542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k)
The same of the same of the collection of the mixelesses of your device to legal This letter will allow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial end the permits your premarket notification. The FDA finding of substanter of your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r the receific advice for your 171, 2115 - the received as a prouletion ent If you desire specific advice for your ac not of the Also, please note the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note the may contact the Office of Compliance at (2-0) 276 of 101.97). You may obtain other
"Misbranding by reference to premarket notification" (21 CFR Part Division of Small " Misbranding by reference to premailities under the Act from the Division of Small general information on your responsibilities and its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-freenumbin html Manufacturers, International and Consumer Pisessuates agov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): Ќ050| 60

Device Name: KATANA Zirconia

Indications For Use:

KATANA Zirconia is intended for CAD/CAM fabrication of zirconia frameworks for allceramic dental restorations.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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

Susan Rumer

KOSOIL

raston Sign-Off) ിച്ച് വിട്ടിക്കാന വിട്ടു. General Hospital, Intection Control, Dental Devices

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