Infinix Universal Composite

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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 13, 2019 Nobio Ltd. % Shoshana Friedman Senior Consultant ProMedoss, Inc. 3521 Hatwynn Rd. Charlotte, North Carolina 28269 Re: K182921 Trade/Device Name: Infinix Universal Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: June 13, 2019 Received: June 18, 2019 Dear Shoshana Friedman: 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 {1}------------------------------------------------ er Federal agencies. You must comply with all the Act's registration and listing (21 CFR Part 807); labeling (21 CFR Part Page 2 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 medical devices and radiation-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, Srinivas Nandkumar, Ph.D. Acting 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) ### K182921 Device Name InfinixTM Universal Composite Indications for Use (Describe) The InfinixTM Universal Composite is indicated for: - · Restorations in the posterior region (Class I and II) - · Anterior restorations (Class III, IV) - · Class V restorations (cervical caries, root erosion, wedge-shaped defects) - · Veneering of discolored anterior teeth - · Splinting of mobile teeth - · Extended fissure sealing in molars and premolars - · Repair of composite/ceramic veneers 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}------------------------------------------------ # 510(K) SUMMARY [as required by section 807.92(c)] Infinix™ Universal Composite 510(k) Number K183921 #### 5.1 SUBMITTER ## Applicant's Name: Nobio Ltd. 8 Hamatechet St. POB 50502 Kadima, Israel 6092000 Phone: +972-3-9059966 ## Contact Person: Shoshana (Shosh) Friedman Regulatory Affairs Consultant 3521 Hatwynn Rd. Charlotte, NC 28269 Phone: 704-430-8695 s.friedman@promedoss.com Date Prepared: June 12, 2019 #### 5.2 DEVICE Trade Name: Infinix™ Universal Composite Classification: Name: Material, Tooth Shade, Resin Product Code: EBF Regulation No: 872.3690 Class: 2 Review Panel: Dental #### 5.3 PREDICATE DEVICE Tetric EvoCeram®, manufactured by Ivoclar Vivadent, cleared under K042819 is the primary predicate device. Additionally, we are using the following reference devices as examples of FDAcleared devices that incorporate quaternary ammonium in their formulation: - Infinix™ Flowable Composite cleared under K182580. • - . Clearfil Protect Bond cleared under K033938 - . Orthodontic Acrylic cleared under K141439 and Orthodontic Acrylic 2 cleared under K163482. {4}------------------------------------------------ #### 5.4 DEVICE DESCRIPTION Infinix™ Universal Composite is a packable (high viscosity) dental composite filling material, intended for direct anterior and posterior restorations, class V restorations, veneering of discolored anterior teeth, and repair of composite/ceramic veneers. The resin matrix of the Infinix™ Universal Composite contains Urethane dimethacrylate (UDMA), Bisphenol-a glycidyl dimethacrylate (Bis-GMA) and triethylene glycol dimethacrylate (TEGDMA). The inorganic filler of the Infinix™ Universal Composite is a mix of particles of alumino-silicate-based glasses, silica dioxide and pigments. A small percentage of the silica-based filler particles are covalently bound to quaternary ammonium residues (OASi), added to maintain the integrity of the restoration. Note: "Clinical studies demonstrating that the presence of QASi in this device improves clinical outcomes have not been conducted". The Infinix™ Universal Composite is provided in syringes (4 g) and in single-dose capsules (0.2 g) and is available in five shades (A1, A2, A3, B1 and translucent). #### ર્સ્ડ INDICATIONS FOR USE Infinix™ Universal Composite is indicated for use in: - Restorations in the posterior region (Class I and II) ● - Anterior restorations (Class III, IV) ● - Class V restorations (cervical caries, root erosion, wedge-shaped defects) ● - . Veneering of discolored anterior teeth - . Splinting of mobile teeth - Extended fissure sealing in molars and premolars ● - . Repair of composite/ceramic veneers #### 5.6 SUBSTANTIAL EQUIVALENCE The InfinixTM Universal Composite has the same indications as the Tetric EvoCeram® by Ivoclar Vivadent. The technological characteristics of the Infinix™ Universal Composite are substantially equivalent to these of the predicate device, the Infinix™ Flowable Composite and other methacrylate-based products currently on the market. Table 5-1 below shows a comparison of Infinix™ Universal Composite and the predicate device. {5}------------------------------------------------ | Feature | Infinix™ Universal Composite | Tetric EvoCeram | |------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K182921 | K042819 | | Classification | EBF | EBF | | Indications | • Restorations in the posterior region<br>(Classes I and II)<br>• Anterior restorations (Classes III, IV)<br>• Class V restorations (cervical caries,<br>root erosion, wedge-shaped defects)<br>• Veneering of discolored anterior teeth<br>• Splinting of mobile teeth<br>• Extended fissure sealing in molars and<br>premolars<br>• Repair of composite/ceramic veneers | • Restoration of deciduous teeth<br>• Restorations in the posterior region<br>(Classes I and II)<br>• Anterior restorations (Classes III, IV)<br>• Class V restorations (cervical caries,<br>root erosion, wedge-shaped defects)<br>• Veneering of discolored anterior teeth<br>• Splinting of mobile teeth<br>• Extended fissure sealing in molars and<br>premolars<br>• Repair of composite/ceramic veneers<br>• Build-ups for transparent, removable,<br>Invisalign® orthodontic retainers | | Composition | Methacrylate resins, photo-<br>initiators, inorganic fillers | Methacrylate resins, photo-<br>initiators, inorganic fillers | | Packaging | Syringe and single-dose capsule | Syringe and single-dose capsule | | Flexural<br>Strength | ISO 4049:2009 | ISO 4049:2009 | | Intensity for<br>curing | ≥550 mW/cm2 | 500 -1000 mW/cm2 | | Wavelength for<br>curing | 430-490 nm | 400-500 nm | | Curing time | 20 sec. | 10 -20 sec* depending on shade | | Radio-opacity | ISO 4049: 2009 | ISO 4049: 2009 | | Depth of Cure | ISO 4049: 2009 | ISO 4049: 2009 | | Water Sorption | ISO 4049:2009 | ISO 4049:2009 | | Water<br>Solubility | ISO 4049:2009 | ISO 4049:2009 | | Spontaneous<br>Polymerization<br>Sensitivity at<br>Ambient Light | ISO 4049:2009 | ISO 4049:2009 | Table 5-1: Comparison of Infinix™ Universal Composite and Tetric EvoCeram® {6}------------------------------------------------ #### 5.7 PERFORMANCE DATA # Non-Clinical Performance Testing: Non-clinical and biological testing was completed to assess the performance and biocompatibility of the Infinix™ Universal Composite and to support substantial equivalence. The data provided in this 510(k) submission shows that the composite is biocompatible based on the biocompatibility assessment conducted as per ISO 10993 and ISO 7405 and performs as intended based on the bench testing per ISO 4049 and FDA guidance document "Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions". The list of these tests is provided in Table 5-2. Table 5-2: List of Tests Completed on Infinix™ Universal Composite | Biocompatibility | |---------------------------------------------------------| | Cytotoxicity | | Oral Mucosal Irritation Test | | Acute Systemic Toxicity | | Material Mediated Pyrogenicity | | Bacterial Reverse Mutation | | Mouse Lymphoma Assay | | Biological Risk Assessment | | Bench Testing | | Flexural strength | | Elastic modulus | | Compression strength | | Shade and color stability | | Polymerization conversion degree | | Viscosity | | Spontaneous polymerization sensitivity at ambient light | | Water solubility | | Water sorption | | Depth of cure | | Radio-opacity | | Knoop hardness | | Preservation of surface integrity | # Animal and Clinical Performance Testing: Animal and clinical performance data was not included. #### 5.8 CONCLUSION Nobio Ltd. believes that Infinix™ Universal Composite is substantially equivalent to the Tetric EvoCeram®, the Infinix™ Flowable Composite and other legally marketed products. It does not introduce new indications for use, has similar technological characteristics and does not introduce any new safety or effectiveness concerns.