TrusFIL-Flow Flowable Composite Restorative

{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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 12, 2022 Rizhao HuGe Biomaterials Company, Ltd. Maggie Zheng Regulatory Affairs Manager No.2 North Zhaoyang Road, District of Donggang Rizhao City, Shandong Province 276800 CHINA Re: K221510 Trade/Device Name: TrusFIL-Flow Flowable Composite Restorative Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: July 6, 2022 Received: July 14, 2022 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. {1}------------------------------------------------ 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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use #### 510(k) Number (if known) K221510 Device Name TrusFIL-Flow Flowable Composite Restorative Indications for Use (Describe) TrusFIL-Flow Flowable Composite Restorative is a visible light curing dental restorative material indicated for: - Class III and V restorations - Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations) - Base/liner under direct restorations - Repair of small defects in indirect restorations - Pit and fissure sealant - Undercut blockout - Repair of resin and acrylic temporary materials | 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 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}------------------------------------------------ ## 005_510 (k) Summary K221510 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: Oct. 11, 2022 ## 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 | | Contact Person | Ms. Maggie Zheng | | Contact Title | Regulatory Affairs Manager | | E-mail | zhengxy@hugedent.com | #### 3. Device Name Trade name: TrusFIL-Flow Flowable Composite Restorative Common name: Flowable Composite Restorative Classification name: Material, Tooth Shade, Resin Regulatory Class: II Product Code: EBF #### 4. Predicate Device Information | Owner/Operator | Device Trade Name | 510 (k) No. | Product Code | Predicate | |-------------------------|----------------------------------------------|-------------|--------------|-----------| | 3M ESPE Dental Products | FILTEK SUPREME ULTRA<br>FLOWABLE RESTORATIVE | K100235 | EBF | Primary | This predicate device has not been subject to a design-related recall. No reference devices were used in this submission. {4}------------------------------------------------ ### 5. Description of Device TrusFIL-Flow Flowable Composite Restorative is a visible light curing dental restorative material intended to restore carious lesions or structural defects in teeth in combination of a bonding agent and with or without other materials such as luting, etching agents, cavity liners, universal composites and others commonly used in a tooth restoration. The principal organic components are mixtures of dental methacrylate resins (Bis-GMA, TEGDMA, EBPADMA). The inorganic filler loading is about 46% by volume having particle size range of about 0.01 to 3 microns. It is packaged in syringes and single-dose capsules. Single-dose delivery is intended for single patient (single use) only to prevent cross-contamination between patients. Available shades include opaque dentin shades and regular body shades. All shades are radiopaque. ### 6. Indications for Use TrusFIL-Flow Flowable Composite Restorative is a visible light curing dental restorative material indicated for: - Class III and V restorations - Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations) - Base/liner under direct restorations - Repair of small defects in indirect restorations - Pit and fissure sealant - Undercut blockout - Repair of resin and acrylic temporary materials ### 7. Summary of Physical Properties Tests TrusFIL-Flow Flowable Composite Restorative is classified as Type 1 Class 2 Group 1 in accordance with ISO 4049: 2019. The physical properties were determined and tested according to ISO 4049: 2019 and FDA guidance "Guidance for Industry and FDA Staff Dental Composite Resin Devices -Premarket Notification [510(k)|Submissions Document issued on: October 26, 2005". {5}------------------------------------------------ # HUGE In-vitro bench tests were performed on the TrusFIL-Flow Flowable Composite Restorative including the items listed in the table below. The test results indicated that the TrusFIL-Flow Flowable Composite Restorative meets the pass/fail criteria and supports substantial equivalence when compared to the predicate device on physical properties. | Items | Pass/fail criteria | Conclusion | |--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------| | ISO 4049: 2019<br>5.2.7 Sensitivity to ambient light,<br>Class 2 materials | The material shall remain physically<br>homogeneous. | Meet the criteria per ISO 4049 | | ISO 4049: 2019<br>5.2.8 Depth of cure, Class 2 materials | Opaque restorative materials: ≥1 mm<br>Other restorative materials: ≥1.5 mm | Meet the criteria per ISO 4049 | | ISO 4049: 2019<br>5.2.9 Flexural strength | The flexural strength shall be equal to or<br>greater than 80 MPa. | Meet the criteria per ISO 4049 | | ISO 4049: 2019<br>5.2.10 Water sorption and solubility | a) The water sorption shall be ≤ 40<br>ug/mm³.<br>b) The solubility shall be shall be ≤ 7.5<br>ug/mm3. | Meet the criteria per ISO 4049 | | ISO 4049: 2019<br>5.3 Shade, restorative materials | The shade of the set material shall match<br>closely that of the manufacturer's shade<br>guide. The set material shall be evenly<br>pigmented when viewed without<br>magnification. | Meet the criteria per ISO 4049 | | ISO 4049: 2019<br>5.4 Colour stability after irradiation<br>and water sorption | No more than a slight change in colour<br>shall be observed. | Meet the criteria per ISO 4049 | | ISO 4049: 2019<br>5.5 Radio-opacity | The radio-opacity shall be equal to or<br>greater than that of the same thickness of<br>aluminium (1 mm of material). | Meet the criteria per ISO 4049 | | FDA guidance<br>Elastic modulus | The elastic modulus shall be equal to or<br>greater than 2 GPa. | Meet the criteria per internal<br>standard | | FDA guidance<br>Surface hardness | The surface hardness shall be equal to or<br>greater than 30HV. | Meet the criteria per internal<br>standard | | Items | Pass/fail criteria | Conclusion | | FDA guidance<br>Compressive strength | The compressive strength shall be equal<br>to or greater than 200 MPa. | Meet the criteria per internal<br>standard | {6}------------------------------------------------ # 미래문 ### 8. Technological Characteristics The following table shows the significant technological characteristics and indicates the similarities and differences with the predicate device: | | Subject device | Primary predicate device | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Technological<br>Characteristics | TrusFIL-Flow Flowable Composite<br>Restorative(K221510) | Filtek Supreme Ultra Flowable<br>Restorative(K100235) | | Composition<br>of Materials | Methacrylate-based resins, photo initiator,<br>fillers and pigments | Methacrylate-based resins, photo initiator,<br>fillers and pigments | | Physical Form | Flowable Paste | Flowable Paste | | Indications of Use | TrusFIL-Flow Flowable Composite<br>Restorative is a visible light curing dental<br>restorative material indicated for:<br>- Class III and V restorations<br>- Restoration of minimally invasive cavity<br>preparations (including small, non<br>stress-bearing<br>occlusal restorations)<br>- Base/liner under direct restorations<br>- Repair of small defects in indirect<br>restorations<br>- Pit and fissure sealant<br>- Undercut blockout<br>- Repair of resin and acrylic temporary<br>materials | Filtek Supreme Flow restorative is indicated<br>for use in:<br>- Class III and V restorations<br>-Restoration of minimally invasive cavity<br>preparations (including small, non<br>stress-bearing<br>occlusal restorations)<br>-Base/liner under direct restorations<br>- Repair of small defects in indirect<br>restorations<br>- Pit and fissure sealant<br>- Undercut blockout<br>-Repair of resin and acrylic temporary<br>materials | | Prescription/over-<br>the-counter use | Prescription | Prescription | | Curing method | Light cure | Light cure | | Delivery form | Syringe and single-dose capsule | Syringe and single-dose capsule | | Radio-opacity | Meet the criteria per ISO 4049 | Meet the criteria per ISO 4049 | | Physical Properties | The subject device and the predicate device have substantially equivalent physical<br>properties as they all meet the criteria per ISO 4049 and conform to FDA guidance<br>"Guidance for Industry and FDA Staff Dental Composite Resin Devices -Premarket<br>Notification [510(k)]Submissions Document issued on: October 26, 2005". | | | Technological<br>Characteristics | Subject device | Primary predicate device | | | TrusFIL-Flow Flowable Composite<br>Restorative(K221510) | Filtek Supreme Ultra Flowable<br>Restorative(K100235) | | FDA-Recognized<br>Standards | ISO 4049; ISO 7405; ISO 10993-1 | ISO 4049; ISO 7405; ISO 10993-1 | {7}------------------------------------------------ All compositions of the subject device are based upon industry well-known chemistry. The technological characteristics of the subject device(K221510) are very similar to those of the predicate device, Filtek Supreme Ultra Flowable Restorative(K100235). The subject device is a similar product, manufactured with similar materials and used in the same way by the same types of users and patient populations. The subject device and primary predicate device have minor different Indications for Use in language. However, the difference does not change the intended use or substantial equivalence, both products are intended for direct anterior and posterior restorations. Besides, other comparison items such as description of material, physical form, curing method, delivery form and physical properties, etc. are the same or very similar. And both products are supplied for prescription use. #### 9. Summary of Biocompatibility The subject device, TrusFIL-Flow Flowable Composite Restorative, is substantially equivalent to the predicate device that have been legally marketed for decades and with no clinical adverse events. The formulation of the subject device does not contain any non-conventional chemicals compared to the legally marketed predicate device. Biocompatibility tests were performed fully following the ISO 10993 standards. The test items include Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Subchronic Toxicity, Genotoxicity and Pulp and Dentine Usage. #### 10. Clinical Performance Data Not applicable. Clinical performance testing has not been performed on the subject device. #### 11. Risk Analysis The risk analysis of TrusFIL-Flow Flowable Composite Restorative was conducted according to ISO 14971. As analyzed, the residual risk of the TrusFIL-Flow Flowable Composite Restorative is considered acceptable. The benefits of the product are considered to outweigh the {8}------------------------------------------------ # HUGE risks outlined in the risk analysis. ## 12. Conclusions Based on the indications for use, technological characteristics, performance testing and comparison to predicate device, the subject device has been shown to be as safe and as effective as the predicate device for its intended use and the minor differences in indications for use fall within the intended use of the predicate device 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 device described herein.