OnX Tough

{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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 14, 2023 SprintRay Inc. Sara Moghtadernejad Regulatory Affairs 2705 Media Center Drive, Suite 100A Los Angeles, California 90065 Re: K230445 Trade/Device Name: OnX Tough Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI, PZY Dated: May 18, 2023 Received: May 19, 2023 Dear Sara Moghtadernejad: 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, Bobak Shirmohammadi -S For Michael E. Adjodha, M. ChE., CQIA 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}------------------------------------------------ 510(k) Number (if known) K230445 Device Name OnX Tough Indications for Use (Describe) SprintRay OnX Tough is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supported denture prosthetics, monolithic full and partial removable dentures, and preformed denture teeth to be used in a denture. | 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 Druq 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 OnX Tough K230445 Submitter: SprintRay Inc. 2705 Media Center Drive, Suite 100A Los Angeles. CA 90065 Phone: (800) 914-8004 Contact Person: Sara Moghtadernejad Date Prepared: July 12, 2023 | Name of Device: | OnX Tough | | | |---------------------------------|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------|--| | Common or Usual Name | Denture, Prescription | | | | Regulation Number and<br>Names: | 21 CFR 872.3760,<br>Denture Relining,<br>Repairing, or Rebasing<br>Resin | 21 CFR 872.3590,<br>Additively Manufactured,<br>Preformed, Resin<br>Denture Tooth | | | Product Codes | EBI | PZY | | | Device Class | II | II<br>510(k)-Exempt | | | Primary Predicate | K221678, SprintRay High Impact Denture Base,<br>(EBI product code) | | | | Secondary Predicate | K151142, IvoBase CAD for Zenotec,<br>(EBI product code) | | | #### Device Description OnX Tough resin consists of a curable dental acrylate resin that is manufactured in a dental office based on a 3D scanned image of a patient's teeth. The acrylate resin material is designed to be used in conjunction with a scanned 3D image, and 3D printer assembly, to locally manufacture out a dental appliance based on the clinician's judgment of patient need. Fabrication of dental prosthetics with OnX Tough resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: oral casting impression, digital denture file created in an optical impression system, 3D printer, and curing light equipment. The material is an alternative to traditional dental prostheses material. OnX Tough resin is intended exclusively for professional dental work. OnX Tough resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered non-sterile, {4}------------------------------------------------ and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves. #### Intended Use / Indications for Use SprintRay OnX Tough is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supported denture prosthetics, monolithic full and partial removable dentures, and preformed denture teeth to be used in a denture. The intended use of fabrication of monolithic full and partial removable dentures is the same as the primary predicate device (K221678) (product code EBI). The fabrication of hybrid denture prosthetics, implant-supported denture prosthetics is the same as the secondary predicate device (K151142) (product code EBI). The fabrication of preformed denture teeth to be used in a denture is Class II, but 510(k)-exempt (product code PZY), therefore no predicate is necessary. The intended use, technological characteristics, and critical specifications, of OnX Tough are similar to both predicate devices. ### Summary of Technological Characteristics OnX Tough and the primary predicate device (K221678) are both 3D printed denture devices. The liquid resin is polymerized in the 3D printer. which creates the final denture device. The secondary predicate device (K151142) is a prepolymerized denture disk that is milled to the final shape of the impression. Here is a more detailed explanation of the two processes: #### OnX Tough and Primary Predicate Device - 1. An impression of the patient's mouth is taken. - 2. The impression is scanned and sent to a 3D printer. - 3. The 3D printer creates a mold of the denture. - 4. The mold is filled with liquid resin. - 5. The resin is polymerized, which creates the final denture device. #### Secondary Predicate Device - 1. An impression of the patient's mouth is taken. - 2. The impression is scanned and sent to a computer. - 3. A pre-polymerized denture disk is created on the computer. - 4. The disk is milled to the final shape of the impression. - 5. The milled disk is placed in the patient's mouth. Both OnX Tough and the primary predicate device are created using 3D printing technology. This technology allows for the creation of custom-fit dentures that are more comfortable and durable than traditional dentures. The secondary predicate device is a less expensive option that is still effective in providing patients with a new set of teeth. The principles of operation are essentially similar; therefore, the OnX Tough is substantially equivalent to its predicate devices. {5}------------------------------------------------ The following technological differences exist between the subject and predicate devices: - Differences in acrylate resin material. ● ### Performance Data The following performance data were provided in support of the substantial equivalence determination. #### Biocompatibility Testing The biocompatibility evaluation for OnX Tough was conducted in accordance with the FDA Blue Book Memorandum #G95-1 and International Standard ISO 10993-1 and ISO 7405, as recognized by FDA. The battery of testing included the following tests: - Genotoxicity ● - Cytotoxicity ● - . Acute Systematic Toxicity - Sensitization ● - . Irritation OnX Tough is considered tissue contacting for a period longer than 30 days (a removable prosthesis). #### Bench Testing OnX Tough was tested for conformity with the industry consensus standard ISO 20795-1. The battery of testing included the following tests: - Flexural Strength and Modulus ● - Water Sorption and Solubility . - . Stability - Residual Methyl Methacrylate Monomers ● - Homogeneity ● - Surface Characteristics ● - Shape Capability, Translucency, and Polishability - Freedom from Porosity - Color Stability ● #### Additive Manufacturing Testing, according to FDA's guidance Technical Considerations for Additive Manufactured Medical Devices, was performed and results were provided in the 510(k). These tests included evaluation of all relevant properties of the printed resin using the permitted machines. Further, tests based on considerations of the orientation during manufacturing were also performed. In all instances, OnX Tough functioned as intended and the outcomes were as expected. {6}------------------------------------------------ ### EQUIVALENCE TO MARKETED DEVICES | | Testing<br>Standards | High Impact<br>Denture Base<br>(Primary<br>Predicate) | IvoBase CAD<br>for Zenotec<br>(Secondary<br>Predicate) | OnX Tough<br>(Subject Device) | |-------------------------------------------|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use &<br>Indications for<br>Use | N/A | The SprintRay<br>High Impact<br>Denture Base<br>resin is a light<br>curable<br>polymerizable<br>resin intended<br>to be used for<br>the fabrication<br>and repair, of<br>full and partial<br>removable<br>dentures and<br>baseplates. The<br>material is an<br>alternative to<br>traditional<br>denture base<br>material. | IvoBase CAD<br>for Zenotec,<br>IvoBase CAD<br>Bond and<br>Modelling<br>Liquid is a<br>system used:<br>For the<br>fabrication of<br>removable<br>dentures e.g.:<br>partial and<br>complete<br>denture<br>prosthetics,<br>hybrid denture<br>prosthetics,<br>combined<br>denture<br>prosthetics,<br>mouthguards,<br>implant-<br>supported<br>denture<br>prosthetics | SprintRay OnX<br>Tough is a tooth<br>shade ceramic-<br>hybrid resin used<br>for the fabrication<br>of hybrid denture<br>prosthetics,<br>implant-supported<br>denture prosthetics,<br>monolithic full and<br>partial removable<br>dentures, and<br>preformed denture<br>teeth to be used in<br>a denture. | | User Population | N/A | Clinicians in<br>dental offices | Clinicians in<br>dental offices | Clinicians in dental<br>offices | | Biocompatibility | ISO- 10993-1,<br>-3, -5, -10<br>and -11 | Passed | Passed | Passed | | Composition | N/A | Methacrylate<br>Monomer/oligo<br>mer s that<br>polymerized to<br>Methymethacyl<br>ate Based<br>polymer | Traditional<br>PMMA<br>Polymer/mono<br>mer denture<br>base material<br>with<br>pigmentation<br>for shade. | Methacrylate<br>Monomer/oligomers<br>that polymerized to<br>Methymethacylate<br>Based polymer. The<br>subject device has<br>similar polymer<br>family to the<br>predicates except<br>for small changes in<br>pigments. | | Principles of<br>operation | N/A | Additive<br>manufacturing<br>of the<br>polymerized<br>denture to the<br>final<br>shape of the<br>impression. | Polymerized<br>denture disk<br>milled to the<br>final shape of<br>the<br>impression. | Additive<br>manufacturing of<br>the polymerized<br>denture to the final<br>shape of the<br>impression. | | Performance<br>Testing | | Testing<br>performed<br>according to<br>ISO standards | Testing<br>performed<br>according to<br>ISO standards | Testing performed<br>according to ISO<br>standards | | Flexural Strength<br>(≥65 MPa) | ISO 20795-1 | $74.69 ± 1.55$ MPa | ≥65 MPa | $71.03 ± 1.45$ MPa | | Flexural Modulus<br>(≥2000 MPa) | ISO 20795-1 | $2253 ± 78$ MPa | ≥2000 MPa | $2271 ± 118$ MPa | | Sorption (≤32 µg/mm³) | ISO 20795-2 | $28 ± 1$ µg/mm³ | ≤32 µg/mm³ | $31 ± 1$ µg/mm³ | | Solubility (≤5 µg/mm³) | ISO 20795-2 | $3.5 ± 0.5$ µg/mm³ | ≤5 µg/mm³ | $4.0 ± 0.5$ µg/mm³ | | Monomer Methyl<br>Methacrylate<br>(≤2.2%) | ISO 20795-1 | Pass | Pass | Pass | | Kmax ≥1.9<br>MPa*m1/2 | ISO 20795-1 | $3.328 ± 0.147$ | 2.5 | $3.176 ± 0.209$ | | Total fracture<br>work,<br>≥900 J/m² | ISO 20795-1 | $1232 ± 119$ | 1172 | $945 ± 88$ | {7}------------------------------------------------ ## Conclusions The OnX Tough resin is as safe and effective as its predicate devices. The OnX Tough has the same intended use and indication, and similar technological characteristics as its predicate devices. The minor technological differences between the OnX Tough and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the OnX Tough is as safe and effective as the predicate devices. Thus, the OnX Tough is substantially equivalent.