BEAUTIBOND MULTI

K110235 · Shofu Dental Corp. · KLE · May 13, 2011 · Dental

Device Facts

• Record ID: K110235
• Device Name: BEAUTIBOND MULTI
• Applicant: Shofu Dental Corp.
• Product Code: KLE · Dental
• Decision Date: May 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

BeautiBond Multi is intended for bonding composite resin to cavity or lesion including dentin. It is also intended for bonding composite resin to ceramics, composite resin, and metals to repair fractured restorations or prostheses.

Device Story

BeautiBond Multi is a dental resin bonding agent used by dentists in clinical settings. It facilitates adhesion between composite resin restorative materials and tooth structure (dentin) or existing dental materials (ceramics, composite, metals) during cavity restoration or repair of fractured prostheses. The device is applied by the clinician to the prepared surface to ensure a durable bond between the restorative material and the substrate.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Resin-based dental bonding agent. Class II device per 21 CFR 872.3200. Product code KLE.

Indications for Use

Indicated for bonding composite resin to dentin in cavities or lesions, and for bonding composite resin to ceramics, composite resin, and metals for the repair of fractured dental restorations or prostheses.

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Submission Summary (Full Text)

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

MAY 1 3 2011

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

Re: K110235

Trade/Device Name: BeautiBond Multi Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: May 5, 2011 Received: May 6, 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 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/Centers0ffices/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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Wh for

Anthony 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

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## Indications for Use

510(k) Number (if known): |< | | 0235

Device Name: BeautiBond Multi

Indications For Use:

.....

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BeautiBond Multi is intended for bonding composite resin to cavity or lesion including dentin. It is also intended for bonding composite resin to ceramics, composite resin, and metals to repair fractured restorations or prostheses.

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 Perm
(Division Sign-Off)

Shofu Dental Corporation BEAUTIBOND MULTI 510(k) Premarket Notification

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