BeautiCem Veneer Kit

K180649 · Shofu Dental Corporation · EBF · Jun 11, 2018 · Dental

Device Facts

• Record ID: K180649
• Device Name: BeautiCem Veneer Kit
• Applicant: Shofu Dental Corporation
• Product Code: EBF · Dental
• Decision Date: Jun 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cementation of ceramic or composite resin laminate veneers and translucent inlays and onlays with a thickness of less than 2 mm

Device Story

BeautiCem Veneer Kit is a dental resin cement system used by dentists for the permanent cementation of ceramic or composite resin laminate veneers, inlays, and onlays. The device is applied in a clinical setting to bond thin (less than 2 mm) translucent restorations to tooth structure. It functions as a restorative material to secure the prosthetic, ensuring aesthetic and functional integration. The kit provides the necessary components for the cementation procedure, facilitating the attachment of dental prosthetics to improve patient oral health and dental function.

Clinical Evidence

Bench testing only.

Technological Characteristics

Tooth shade resin material; Class II; Product Codes EBF, KLE, EMA. The device is a chemical-based dental cement system. No electronic, software, or mechanical sensing components are involved.

Indications for Use

Indicated for the cementation of ceramic or composite resin laminate veneers and translucent inlays and onlays with a thickness of less than 2 mm in patients requiring dental restorative procedures.

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

• BeautiCem SA (K102638)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

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

Re: K180649

Trade/Device Name: BeautiCem Veneer Kit Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF, KLE, EMA Dated: March 12, 2018 Received: March 13, 2018

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

June 11, 2018

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely. Mary S. Runner -5

For 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) K180649

Device Name BeautiCem Veneer Kit

## Indications for Use (Describe)

Cementation of ceramic or composite resin laminate veneers and translucent inlays and onlays with a thickness of less than 2 mm

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

| <span> <b> ☑ </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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