BEAUTIFIL II Gingiva

K151700 · Shofu Dental Corporation · EBF · Mar 2, 2016 · Dental

Device Facts

• Record ID: K151700
• Device Name: BEAUTIFIL II Gingiva
• Applicant: Shofu Dental Corporation
• Product Code: EBF · Dental
• Decision Date: Mar 2, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Class V restorations (Cervical caries, root caries, wedge-shaped defects) Covering of exposed or discolored necks of teeth Restoration of esthetic appearance of gingival areas

Device Story

Beautifil II Gingiva is a light-cured, radiopaque, resin-based restorative material used by dental professionals in clinical settings. It is designed to address gingival esthetic concerns, including cervical caries, root caries, wedge-shaped defects, and exposed or discolored tooth necks. The material is applied by a dentist to the affected area to restore tooth structure and improve appearance. It functions as a direct restorative material, providing a physical barrier and esthetic match for gingival tissues.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison to legally marketed predicate devices.

Technological Characteristics

Light-cured, radiopaque, resin-based restorative material. Formulated for gingival esthetic applications. Class II device per 21 CFR 872.3690.

Indications for Use

Indicated for patients requiring Class V restorations (cervical/root caries, wedge-shaped defects), covering of exposed or discolored tooth necks, and restoration of gingival esthetics.

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

March 2, 2016

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

Re: K151700

Trade/Device Name: Beautifil II Gingiva Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: January 25, 2016 Received: January 27, 2016

Dear Mr. 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.

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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 (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,

Tina Kiang
-s

for Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K151700

## Device Name

BEAUTIFIL II Gingiva

Indications for Use (Describe)

- · Class V restorations (Cervical caries, root caries, wedge-shaped defects)
- Covering of exposed or discolored necks of teeth
- Restoration of esthetic appearance of gingival areas

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
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