KATANA Zirconia Block

K170986 · Kuraray Noritake Dental, Inc. · EIH · Jul 13, 2017 · Dental

Device Facts

• Record ID: K170986
• Device Name: KATANA Zirconia Block
• Applicant: Kuraray Noritake Dental, Inc.
• Product Code: EIH · Dental
• Decision Date: Jul 13, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

KATANA Zirconia Block is used for the fabrication of the ceramic restorations (FCZ crowns, inlays, onlays and veneers).

Device Story

KATANA Zirconia Block is a dental ceramic material used by dental professionals for the fabrication of restorations including full-contour zirconia (FCZ) crowns, inlays, onlays, and veneers. The device is a pre-sintered zirconia block processed via CAD/CAM milling systems in a dental laboratory or clinical setting. Following milling, the restoration is sintered to achieve final mechanical properties and aesthetic characteristics. The resulting ceramic restoration is then cemented or bonded to the patient's prepared tooth structure by a dentist. The device provides a durable, biocompatible, and aesthetic solution for tooth replacement or repair.

Clinical Evidence

Bench testing only.

Technological Characteristics

Zirconia-based ceramic material. Form factor: pre-sintered blocks for CAD/CAM milling. Intended for sintering to final density. Biocompatible dental ceramic.

Indications for Use

Indicated for fabrication of ceramic restorations including full-contour zirconia (FCZ) crowns, inlays, onlays, and veneers in dental patients requiring restorative treatment.

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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July 13, 2017

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

Kuraray Noritake Dental Inc. Yasuiiro Ohara Manager, Ouality Assurance Department Ote Center Bldg. 7F Chiyoda-ku. 100-0004 JAPAN

Re: K170986

Trade/Device Name: KATANA Zirconia Block Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: April 17, 2017 Received: April 18, 2017

Dear Yasujiro Ohara:

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.

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 device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Industry and Consumer Education at its toll-free 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" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

## Mary S. Runner -A

Lori Wiggins, MPT, CLT Acting 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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## Indications for Use

510(k) Number (if known): K170986

Device Name: KATANA Zirconia Block

Indications for Use:

KATANA Zirconia Block is used for the fabrication of the ceramic restorations (FCZ crowns, inlays, onlays and veneers).

Prescription Use ___ V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)