KATANA AVENCIA Block

K153476 · Kuraray Noritake Dental, Inc. · EBF · Aug 23, 2016 · Dental

Device Facts

• Record ID: K153476
• Device Name: KATANA AVENCIA Block
• Applicant: Kuraray Noritake Dental, Inc.
• Product Code: EBF · Dental
• Decision Date: Aug 23, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fabrication of inlays, onlays, veneers and full contour crown restorations, using a dental CAD/CAM system.

Device Story

KATANA AVENCIA Block is a dental restorative material designed for use with CAD/CAM systems. The block is milled by a dental professional to create inlays, onlays, veneers, and full contour crowns. The device serves as a substrate for computer-aided design and manufacturing, allowing for the fabrication of custom dental prosthetics. It is intended for use in a clinical or laboratory setting by dental professionals to restore tooth structure, providing a durable and aesthetic solution for patients requiring restorative dental care.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Resin-based dental restorative material block for CAD/CAM milling. Class II device (21 CFR 872.3690).

Indications for Use

Indicated for fabrication of inlays, onlays, veneers, and full contour crown restorations in dental patients requiring restorative treatment using CAD/CAM systems.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• CERASMART (K142536)

Submission Summary (Full Text)

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

August 23, 2016

Kuraray Noritake Dental, Inc. Mr. Michio Takigawa Manager Ote Center Bldg. 7F, 1-1-3, Otemachi Chiyoda-ku, Tokyo 100-0004 JAPAN

Re: K153476

Trade/Device Name: KATANA AVENCIA Block Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: July 28, 2016 Received: July 29, 2016

Dear Michio. Takigawa:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 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 yours,

Susan Runno DDS, MA

Tina Kiang, Ph.D. 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): K153476

Device Name: KATANA AVENCIA Block

Indications for Use:

Fabrication of inlays, onlays, veneers and full contour crown restorations, using a dental CAD/CAM system.

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 (ODE)