BEAUTIFIL FLOW PLUS

K101603 · Shofu Dental Corp. · EBF · Aug 23, 2010 · Dental

Device Facts

• Record ID: K101603
• Device Name: BEAUTIFIL FLOW PLUS
• Applicant: Shofu Dental Corp.
• Product Code: EBF · Dental
• Decision Date: Aug 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Beautifil Flow Plus is a light-curing dental filling material having low viscosity intended to directly restore cavities and lesions (except for root canal filling), and to repair fractured artificial crowns.

Device Story

Beautifil Flow Plus is a light-curing, low-viscosity dental restorative material. Used by dental professionals in clinical settings to fill cavities, treat lesions, and repair fractured artificial crowns. Material is applied directly to the tooth structure and cured using a dental light-curing unit. The restorative material replaces lost tooth structure, restoring function and aesthetics to the patient's dentition.

Clinical Evidence

Bench testing only.

Technological Characteristics

Light-curing dental resin; low-viscosity formulation; intended for direct restorative applications.

Indications for Use

Indicated for direct restoration of dental cavities and lesions (excluding root canal filling) and repair of fractured artificial crowns 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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings and a head. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

Mr. David P. Morais Operations Manager and Official Correspondent Shofu Dental Corporation 1225 Stone Drive San Marcos, California 92078-4059

AUG 2 3 2010

Re: K101603

Trade/Device Name: Beautifil Flow Plus Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Regulatory Class: II Product Code: EBF Dated: June 7, 2010 Received: June 8, 2010

Dear Mr. Morais:

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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## Page 2 - Mr. David P. 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, 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):

K101603

Device Name: Beautifil Flow Plus

Indications For Use:

Beautifil Flow Plus is a light-curing dental filling material having low viscosity intended to directly restore cavities and lesions (except for root canal filling), and to repair fractured artificial crowns.

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

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

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

Concurrence of CDRH Office of

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: Shofu Dental Corporation BEAUTIFIL FLOW PLUS 510(k) Premarket Notification

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