BeautiBond Universal

K180803 · Shofu Dental Corporation · KLE · Sep 26, 2018 · Dental

Device Facts

• Record ID: K180803
• Device Name: BeautiBond Universal
• Applicant: Shofu Dental Corporation
• Product Code: KLE · Dental
• Decision Date: Sep 26, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Direct restorations with light-cured composite resin; Repairs of fractured restorations with light-cured composite resin; Cementation of indirect restorations with light- or dual-cured resin cement; Core build-up with light- or dual-cured core materials

Device Story

BeautiBond Universal is a dental resin bonding agent used by dental professionals in clinical settings. It functions as an adhesive interface between tooth structure and restorative materials. The device is applied to prepared tooth surfaces to facilitate bonding of light-cured composite resins, repair of existing restorations, cementation of indirect restorations, and core build-up procedures. It ensures mechanical and chemical adhesion, improving the retention and marginal integrity of dental restorations. The clinician applies the agent during restorative procedures to enhance clinical outcomes and restore tooth function.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and technological comparison.

Technological Characteristics

Resin tooth bonding agent; Class II device; Product codes KLE, EMA, EBF. Formulated for compatibility with light-cured and dual-cured restorative materials.

Indications for Use

Indicated for patients requiring direct composite resin restorations, repair of fractured restorations, cementation of indirect restorations using light- or dual-cured resin cements, and core build-up procedures using light- or dual-cured materials.

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)

{0}------------------------------------------------

September 26, 2018

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION".

Shofu Dental Corporation Mauro Malzyner Regulatory Affairs Coordinator 1225 Stone Drive San Marcos, California 92078

Re: K180803

Trade/Device Name: BeautiBond Universal Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE, EMA, EBF Dated: July 2, 2018 Received: July 5, 2018

Dear Mauro Malzyner:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

## Mary S. Runner -S3

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known)

K180803

Device Name

BeautiBond Universal

Indications for Use (Describe)

- · Direct restorations with light-cured composite resin
- · Repairs of fractured restorations with light-cured composite resin
- · Cementation of indirect restorations with light- or dual-cured resin cement
- · Core build-up with light- or dual-cured core materials

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------|
| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."