BEAUTIFIL II Enamel by SHOFU DENTAL CORPORATION

BEAUTIFIL II Enamel is a light-cured radiopaque restorative material, designed for anterior restorations as well as posterior restorations including for restorations involving occlusal surfaces. It can also be used for repair of restorations and prostheses.
(Indications)
· Direct anterior and posterior restorations (except for tooth root)
· Repair of restorations and prostheses

Device Description

BEAUTIFIL II Enamel is a light-cured radiopaque restorative material.

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental restorative material, not an AI/ML device. Therefore, it does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study methodologies typically associated with AI/ML device evaluations.

The document mainly focuses on:

Device Name: Beautifil II Enamel
Regulation Number: 21 CFR 872.3690
Regulation Name: Tooth shade resin material
Regulatory Class: II
Product Code: EBF
Indications for Use: Direct anterior and posterior restorations (except for tooth root), and repair of restorations and prostheses.
FDA Determination: Substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information for acceptance criteria and study data because this document pertains to a traditional medical device (dental filling material) and does not involve AI/ML technology or associated performance studies in the context of diagnostic or prognostic capabilities.

Summary

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

December 10, 2015

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

Re: K151699

Trade/Device Name: Beautifil II Enamel Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: II Product Code: EBF Dated: November 10, 2015 Received: November 12, 2015

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 device-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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Tina Kiang -

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

510(k) Number (if known)

K151699

Device Name

BEAUTIFIL II Enamel

Indications for Use (Describe)

(Indications)

· Direct anterior and posterior restorations (except for tooth root)

· Repair of restorations and prostheses

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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Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
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.(b)
Classification. Class II.