BeautiBond Xtreme

K213965 · Shofu Dental Corporation · KLE · Mar 18, 2022 · Dental

Device Facts

• Record ID: K213965
• Device Name: BeautiBond Xtreme
• Applicant: Shofu Dental Corporation
• Product Code: KLE · Dental
• Decision Date: Mar 18, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Direct restorations with light-cured composite resin; Repair of fractured restorations with light-cured composite resin; Post cementation and core build-up; Cementation of indirect restorations with light-cured/dual-cured resin cement; Treatment of hypersensitive teeth or exposed root surface; Sealing of tooth preparation (cavity or abutment) for indirect restorations

Device Story

BeautiBond Xtreme is a resin tooth 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 for direct composite restorations, repair of existing restorations, post cementation, core build-up, and the cementation of indirect restorations. It also serves to seal tooth preparations and treat hypersensitive teeth or exposed root surfaces. The clinician applies the material to the tooth, which then interacts with the restorative material to ensure adhesion. This process improves the retention and marginal integrity of dental restorations, benefiting the patient by restoring tooth function and aesthetics while reducing sensitivity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Resin-based dental bonding agent. Chemical composition includes monomers and solvents typical of light-cured adhesive systems. Designed for use with light-cured or dual-cured resin cements and composite resins. No electronic components or software.

Indications for Use

Indicated for dental patients requiring direct composite resin restorations, repair of fractured restorations, post cementation, core build-up, cementation of indirect restorations, treatment of hypersensitive teeth/exposed root surfaces, and sealing of tooth preparations.

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}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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 logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

March 18, 2022

Shofu Dental Corporation Mauro Malzyner Official Correspondent 1225 Stone Drive San Marcos, California 92078

Re: K213965

Trade/Device Name: BeautiBond Xtreme Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: December 10, 2021 Received: December 20, 2021

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

510(k) Number (if known) K213965

Device Name BeautiBond Xtreme

Indications for Use (Describe)

- · Direct restorations with light-cured composite resin
- · Repair of fractured restorations with light-cured composite resin
- · Post cementation and core build-up
- · Cementation of indirect restorations with light-cured/dual-cured resin cement
- · Treatment of hypersensitive teeth or exposed root surface
- · Sealing of tooth preparation (cavity or abutment) for indirect restorations

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

## 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."