CERAMAGE UP

K162261 · Shofu Dental Corporation · EBF · Jan 11, 2017 · Dental

Device Facts

• Record ID: K162261
• Device Name: CERAMAGE UP
• Applicant: Shofu Dental Corporation
• Product Code: EBF · Dental
• Decision Date: Jan 11, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fabrication of permanent & temporary indirect restorations Crowns & Bridges for anterior and posterior restorations Jacket crowns for anterior and posterior restorations Inlays & Onlays Laminate veneers Implant superstructures Intraoral & extraoral repairs of indirect restorations

Device Story

Ceramage Up is a light-cured, indirect restorative material used by dental professionals in clinical or laboratory settings. It is utilized for the fabrication of permanent and temporary dental restorations, including crowns, bridges, inlays, onlays, laminate veneers, and implant superstructures. The material is also indicated for the repair of existing indirect restorations. The device is applied by the clinician or dental technician to create or repair dental prosthetics, which are then cured to achieve final hardness. The resulting restorations provide functional and aesthetic replacement for missing or damaged tooth structure, benefiting the patient by restoring dental form and function.

Clinical Evidence

Bench testing only.

Technological Characteristics

Light-cured, indirect restorative resin material. Classified as a tooth shade resin material under 21 CFR 872.3690. Formulated for use in dental restorations and repairs.

Indications for Use

Indicated for patients requiring permanent or temporary indirect dental restorations, including crowns, bridges, jacket crowns, inlays, onlays, laminate veneers, and implant superstructures, as well as for intraoral and extraoral repairs of indirect restorations.

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.

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

January 11, 2017

Shofu Dental Corporation Mauro Malzyner Regulatory Affairs And Official Correspondent 1225 Stone Drive San Marcos, California 92078

Re: K162261

Trade/Device Name: Ceramage Up Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: August 9, 2016 Received: August 11, 2016

Dear Mauro Malzyner:

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 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.

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Page 2 - Mauro Malzyner

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,

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)

Device Name

CERAMAGE UP

Indications for Use (Describe)

- · Fabrication of permanent & temporary indirect restorations
- · Crowns & Bridges for anterior and posterior restorations
- · Jacket crowns for anterior and posterior restorations
- · Inlays & Onlays
- · Laminate veneers
- · Implant superstructures
- · Intraoral & extraoral repairs of indirect restorations

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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