BEAUTISEALANT

K111782 · Shofu Dental Corporation · EBC · Sep 16, 2011 · Dental

Device Facts

• Record ID: K111782
• Device Name: BEAUTISEALANT
• Applicant: Shofu Dental Corporation
• Product Code: EBC · Dental
• Decision Date: Sep 16, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3765
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

BeautiSealant is resin material intended for sealing of pits and fissures, which is polymerized by visible light energy (external energy). 'Primer' modifies enamel surface with its adhesive monomer to bond 'Paste' to enamel.

Device Story

BeautiSealant is a light-cured resin-based pit and fissure sealant system. It consists of a primer and a paste. The primer modifies the enamel surface using an adhesive monomer to facilitate bonding. The paste is applied to the pits and fissures and polymerized using an external visible light source. The device is used by dental professionals in a clinical setting to seal tooth surfaces, thereby preventing the development of dental caries. The system provides a physical barrier on the occlusal surfaces of teeth.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technological characteristics to predicate devices.

Technological Characteristics

Resin-based pit and fissure sealant system. Components: Primer and Paste. Polymerization: Visible light-cured. Class II medical device (21 CFR 872.3765).

Indications for Use

Indicated for sealing pits and fissures in dental enamel to prevent caries. For prescription use only.

Regulatory Classification

Identification

A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Flampshire Avenue Document Control Room -WQ66-G609 Silver Spring, MD 20903-0002

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

SEP 16 2011

Re: K111782

Trade/Device Name: BeautiSealant Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC Dated: June 24, 2011 Received: June 24, 2011

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. 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 fisting (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.

1f 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/ucm] 15809.html 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.

Wh 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): K

Device Name: BeautiSealant

Indications For Use:

BeautiSealant is resin material intended for sealing of pits and fissures, which is polymerized by visible light energy (external energy). 'Primer' modifies enamel surface with its adhesive monomer to bond 'Paste' to enamel.

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)

Susan Runore

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

Shofu Dental Corporation BEAUTISEALANT 510(k) Premarket Notification 510(k) Number

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