Light Cure Dental Adhesive

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 25, 2020 Maggie Zheng, Regulatory Affairs Manager Rizhao HuGe Biomaterials Company, Ltd. No.2 North Zhaoyang Road, District of Donggang Rizhao City, CHINA 276800 Shandong Province Re: K201787 Trade/Device Name: Light Cure Dental Adhesive Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: July 17, 2020 Received: July 27, 2020 Dear Maggie Zheng: 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K201787 Device Name Light Cure Dental Adhesive Indications for Use (Describe) Light Cure Dental Adhesive can be used as a strict self-etch dental bonding agent, or in combination with the traditional total etch or enamel etch procedures: - Direct bonding under a light-cured composite or compomer fillings/resin modified glass ionomer restoratives; - Repair of dental restorations of ceramic, composites and/or metal alloys; - Indirect dental restoration applications in combination with resin cement for cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers, dental posts and other restorations made from materials of metals/alloys, mental-ceramic and/or porcelain, composites, and their combinations. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| > 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 PRAStaff(@fda.hhs.gov "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." {3}------------------------------------------------ # K201787 # 510 (k) Summary This summary of 510(k) for the subjective device equivalence information is being submitted in accordance with the requirements of 21 C.F.R. 807.92. - 1. Date Summary Prepared: September 25, 2020 - 2. Submitter Information: | Owner's Name | Rizhao HuGe Biomaterials Company, Ltd. | |----------------|-------------------------------------------------------------------------------------------------| | Address | No.2 North Zhaoyang Road, District of Donggang, Rizhao City,<br>Shandong Province, China 276800 | | Telephone | 0086 633 2277268 | | Fax | 0086 633 2277298 | | Contact Person | Mrs. Maggie Zheng | | Contact Title | Regulatory Affairs Manager | | E-mail | zhengxy@hugedent.com | ### 3. Device Name Trade name: Light Cure Dental Adhesive Common name: Dental Adhesive Classification name: Resin Tooth Bonding Agent (21 CFR 872.3200) Regulatory Class: II Product Code: KLE ### 4. Predicate Device Information | Table 1: Predicate Device Information | | | | | |---------------------------------------|-------------------|-------------|--------------|-----------| | Owner/Operator | Device Trade Name | 510 (k) No. | Product Code | Predicate | | BISCO, INC. | DREAMBOND | K112118 | KLE | Primary | This predicate device has not been subject to a design-related recall. No reference devices were used in this submission. #### 5. Description of Device {4}------------------------------------------------ Light Cure Dental Adhesive is a universal self-etch visible light curable dentine bonding agent specifically designed for meeting all your bonding needs. It is not only for direct bonding under a dental composite restorative or a resin modified glass ionomer cement restorative, but also for all indirect dental restoration applications, either used as a strict self-etch dental bonding agent, or in combination with the traditional total etch or enamel etch procedures. In all of those cases, this dental bonding agent will give you exceptional results and predicting a reliable treatment outcome. ### 6. Indications for Use Light Cure Dental Adhesive can be used as a strict self-etch dental bonding agent, or in combination with the traditional total etch or enamel etch procedures: - Direct bonding under a light-cured composite or compomer fillings/resin modified glass ionomer restoratives; - Repair of dental restorations of ceramic, composites and/or metal alloys; - Indirect dental restorations cementation applications in combination with resin cement for cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers, dental posts and other restorations made from materials of metals/alloys, mental-ceramic, all-ceramic and/or porcelain, composites, and their combinations. ### 7. Summary of Physical and Chemical Properties Tests Test standards and methods based on ISO 29022: 2013 (Dentistry - Adhesive - Notched-edge sheer bond strength test) and internal final inspection standard of Rizhao HuGe Biomaterials Company, Ltd.. And the results from testing demonstrate that Light Cure Dental Adhesive is substantially equivalent to the predicate device. #### 8. Technological Characteristics All components of the subject device are based upon industry well-known chemistry. The etch methods of the subject device and predicate device covered the flexibility for total-, self- and selective-etch procedures. The following table shows the significant technological characteristics for the subject device and indicates the following similarities and differences with the predicate device: | Table 4: Technological Characteristics Comparison Table | | | |---------------------------------------------------------|------------------------------------------------|------------------------------| | Technological<br>Characteristics | Subject device<br>(Light Cure Dental Adhesive) | Primary predicate<br>K112118 | {5}------------------------------------------------ | Method of<br>polymerization | Light Cured | Light Cured | | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Resin<br>composition | Unfilled, multifunctional methacrylate resin | Unfilled, multifunctional methacrylate resin | | | Solvent | Ethanol based | Ethanol based | | | Method of<br>application | Single component adhesive | Single component adhesive | | | Indications of<br>Use | Light Cure Dental Adhesive can be used as a<br>strict self-etch dental bonding agent, or in<br>combination with the traditional total etch or<br>enamel etch procedures:<br>- Direct bonding under a light-cured<br>composite or compomer fillings/resin<br>modified glass ionomer restoratives;<br>- Repair of dental restorations of ceramic,<br>composites and/or metal alloys;<br>- Indirect dental restorations cementation<br>applications in combination with resin<br>cement for cementation of all sorts of dental<br>restorations including crowns, bridges,<br>inlays/onlays, veneers, dental posts and other<br>restorations made from materials of<br>metals/alloys, mental-ceramic, all-ceramic<br>and/or porcelain, composites, and their<br>combinations. | The indications of use of DREAMBOND<br>are:<br>1. all direct restorations<br>2. all indirect restorations<br>3. intra-oral repairs (i.e. repair. of any fixed<br>dental prosthesis containing zirconia,<br>alumina, metals, glass ceramics, tooth<br>structure, and composites)<br>4. desensitizing/sealing of tooth structure<br>5. protective varnish for glass ionomer<br>fillings<br>6. priming of enamel for orthodontic use | | | Prescription/over-<br>the-counter use | Prescription | Prescription | | | Etch Method | Total-etch, self-etch and selective-etch<br>procedures | Total-etch, self-etch and selective-etch<br>procedures | | | Physical<br>Properties | The subject device and the predicate device have substantially equivalent physical property<br>of shear bond strength as they all conform to the specifications set by internal final<br>inspection and the test method equal to ISO 29022:2013 | | | ## 9. Summary of Biocompatibility The new device, Light Cure Dental Adhesive, is substantially equivalent to the predicate devices that have been legally marketed for decades and with no clinical adverse events. The formulation of new device does not contain any non-conventional chemicals compared to the legally marketed predicate device. We selected our Light Cure Dental Adhesive (6mL) as the representative model in biocompatibility tests. Because our company only has one component formula for this product. The chemical compositions, raw material suppliers, curing method and other technological characteristic in all packing specifications are identical, the difference only depends on the quantity. {6}------------------------------------------------ The packaging bottle materials used for all packaging specifications are the same, and the packaging method is the same. Therefore, the packaging specifications differences in the delivery system affect neither the intended use nor substantial equivalence. Biocompatibility tests were performed fully following the ISO 10993 standards. The test items include Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Subchronic Toxicity and Genotoxicity. ## 10. Clinical Performance Data Not applicable. Clinical performance testing has not been performed for the subject device. ### 11. Conclusions Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the subject device has been shown to be safe and effective for its intended use and the minor differences in indications for use fall within the intended use of the predicate devices affecting neither the general intended use nor substantial equivalence. Rizhao HuGe Biomaterials Company, Ltd. concludes that the subject device is substantially equivalent to the predicate devices described herein.