CERARESIN BOND

K123119 · Shofu Dental Corporation · KLE · Nov 28, 2012 · Dental

Device Facts

• Record ID: K123119
• Device Name: CERARESIN BOND
• Applicant: Shofu Dental Corporation
• Product Code: KLE · Dental
• Decision Date: Nov 28, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CERARESIN BOND is a light-curing bonding system for intraoral and extraoral repairs of dental ceramic and resin restorations or prostheses (facing crowns, veneers and implant superstructures) as well as artificial teeth (porcelain, hard resin and acrylic resin teeth) using direct/indirect composite resin.

Device Story

Ceraresin Bond is a light-curing dental bonding system used for intraoral and extraoral repairs of ceramic and resin restorations, prostheses, and artificial teeth. The device is applied by dental professionals in a clinical setting to facilitate the adhesion of composite resin to various dental materials. It functions as a chemical bonding agent to repair damaged or worn dental structures, improving the longevity and functionality of restorations. The system is used during restorative dental procedures to bond composite materials to porcelain, hard resin, or acrylic surfaces.

Clinical Evidence

Bench testing only.

Technological Characteristics

Light-curing dental bonding system; chemical composition designed for adhesion to ceramic and resin substrates; intended for use with direct/indirect composite resins.

Indications for Use

Indicated for intraoral and extraoral repair of dental ceramic and resin restorations, prostheses (crowns, veneers, implant superstructures), and artificial teeth (porcelain, hard resin, acrylic) using direct/indirect composite resin.

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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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

## November 28, 2012

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

Re: K123119

Trade/Device Name: Ceraresin Bond Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: September 25, 2012. Received: October 3, 2012

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 Eederal 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/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,

2012.11.28 Susan Runner DDS, MA -05-25:37 -05'00'

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

Kl.23119

510(k) Number (if known):

Device Name: CERARESIN BOND

Indications For Use:

CERARESIN BOND is a light-curing bonding system for intraoral and extraoral repairs of dental ceramic and resin restorations or prostheses (facing crowns, veneers and implant superstructures) as well as artificial teeth (porcelain, hard resin and acrylic resin teeth) using direct/indirect composite resin.

Prescription Use X (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 (ODGD2.11.28 Device Evaluation (ODS, MAS 12:12:42 -055'00'

12:12:42 -05'00'

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

510(k) Number:

Shofu Dental Corporation CERARESIN BOND 510(k) Premarket Notification İX