BEAUTIFIL BULK FLOWABLE

K132141 · Shofu Dental Corporation · EBF · Oct 3, 2013 · Dental

Device Facts

• Record ID: K132141
• Device Name: BEAUTIFIL BULK FLOWABLE
• Applicant: Shofu Dental Corporation
• Product Code: EBF · Dental
• Decision Date: Oct 3, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Base in Class I and II direct restorations . Liner under direct restorative materials . Restorations of small posterior cavities (including occlusal restorations)

Device Story

Beautifil Bulk Flowable is a light-cured, radiopaque, flowable resin composite material. It is intended for use by dental professionals in clinical settings for restorative dentistry. The material is applied to the tooth cavity to serve as a base, liner, or restorative material for small posterior cavities. It is cured using a dental light-curing unit. The device provides a restorative solution for dental caries, helping to restore tooth structure and function.

Clinical Evidence

Bench testing only.

Technological Characteristics

Light-cured, radiopaque, flowable resin composite. Material composition includes resin matrix and filler particles. Form factor is a flowable paste delivered via syringe. Polymerization initiated by external dental light-curing unit.

Indications for Use

Indicated for use as a base in Class I and II direct restorations, as a liner under direct restorative materials, and for the restoration of small posterior cavities, including occlusal 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.

Predicate Devices

• Beautifil-Flow Plus (K103637)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

## October 3, 2013

Shofu Dental Corporation Mr. David P. Morais Director of Operations and Official Correspondent 1225 Stone Drive SAN MARCOS CA 92078-4059

Re: K132141

Trade/Device Name: Beautifil Bulk Flowable Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: June 26, 2013 Received: July 11, 2013

## Dear Mr. Morais:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your boodeermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the enoresary to the enactment date of the Medical Device Amendments, or to conninered phorts way 20, 11, 11, accordance with the provisions of the Federal Food, Drug, de nees that have ooon 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 I he general connous provisions 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 finay be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Morais

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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

MaryS-Bunner-S

Kwame Ulmer M.S. Acting Division 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): K132141

Device Name: BEAUTIFIL BULK FLOWABLE

Indications For Use:

- . Base in Class I and II direct restorations
- . Liner under direct restorative materials
- . Restorations of small posterior cavities (including occlusal restorations)

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Andrew I. Steen 2013.10.03 12:46:39 -04'00'

Shofu Dental Corporation BEAUTIFIL BULK FLOWABLE 510(k) Premarket Notification İX