Digital Crown

{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. December 14, 2022 SprintRay Inc. Sara Moghtadernejad Regulatory Affairs Manager 2705 Media Center Drive, Suite 100A Los Angeles, California 90065 Re: K222623 Trade/Device Name: Digital Crown Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF, EBI, ELM Dated: September 15, 2022 Received: September 15, 2022 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 {1}------------------------------------------------ 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, Image /page/1/Picture/5 description: The image shows the name "Michael E. Adjodha" in a clear, sans-serif font. Below the name, there is a "-S". The background of the image has a faint watermark of the letters "FDA". 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}------------------------------------------------ 510(k) Number (if known) K222623 Device Name #### Digital Crown Indications for Use (Describe) SprintRay Digital Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material. 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 Digital Crown K222623 Submitter: SprintRay Inc. 2705 Media Center Drive, Suite 100A Los Angeles, CA 90065 Phone: +1 (800) 914-8004 Contact Person: Sara Moghtadernejad Date Prepared: November 22, 2022 | Name of Device: | Digital Crown (K222623) | |--------------------------|-------------------------------------------| | Common or Usual Name: | Tooth Shade Resin Material | | Classification Name: | Tooth Shade Resin Material | | Regulatory Class: | Class II | | Regulation Number: | 21 CFR 872.3690 | | Product Code: | EBF | | Secondary Product Codes: | EBI, ELM | | Predicate Device: | E-Dent 1000 (K210977) (Primary Predicate) | # Device Description SprintRay Digital Crown 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 SprintRay Digital Crown resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: oral casting impression, digital crown file created in an optical impression system, 3D printer, and curing light equipment. SprintRay Digital Crown Resin is intended exclusively for professional dental work. Digital Crown Resin is offered in following shades/colors: Bleach, A1, B1. The device is manufactured via additive manufacturing process using a 3D printer with 405 nm wavelength, 50 m print layer thickness, and light energy of 28.8 mW/cm². {4}------------------------------------------------ Digital Crown resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered nonsterile, 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 Digital Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material. # Summary of Technological Characteristics Light-based curing of a 3D printed acrylate resin is the technological principle for both the subject and predicate devices. Digital Crown resin is poured into a 3D printer, which relies on scanned images of the patient's oral cavity to produce a dental appliance. At a high level, the subject and predicate devices are based on the following same technological elements: - . are a pourable acrylate resin - are used in conjunction with 3D printers. which rely on common 3D images . to define the fabricated dental appliance - . are cured prior to final trimming and cleaning - are used for the fabrication of orthodontic and dental appliances ● The following technological differences exist between the subject and predicate devices: differences in acrylate resin material composition # Performance Data The following performance data were provided in support of the substantial equivalence determination. # Biocompatibility Testing The biocompatibility evaluation for Digital Crown 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 ● {5}------------------------------------------------ - · Irritation Digital Crown is considered tissue contacting for a period longer than 30 days. ### Bench Testing Additional bench testing based on the test steps laid out in ISO 10477 and ISO 4049 was performed using dental appliance fabricated from Digital Crown resin. - Flexural Strength and Modulus ● - Water Sorption and Solubility - Radio-opacity ● - . Print Accuracy and Dimensional Stability - Shape Capability, Translucency, and Polishability - Freedom from Porosity ● - Color Stability and Shade Consistency ● - Residual Methyl Methacrylate Monomers ● - Stability In all instances, Digital Crown resin functioned as intended and the outcomes were as expected. | Feature | EnvisionTEC's E-Dent 1000 | SprintRay Digital Crown | Conclusion | |---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Product Code | EBF<br>EBI<br>ELM | EBF<br>EBI<br>ELM | Similar | | Regulation | 21 CFR 872.3690<br>21 CFR 872.3760<br>21 CFR 872.3590 | 21 CFR 872.3690<br>21 CFR 872.3760<br>21 CFR 872.3590 | Similar | | Intended Use &<br>Indications for Use | E-Dent 1000 is a light-curable resin indicated for the fabrication of: individual and fixed permanent full single crowns, permanent partial crowns in front and posterior area, individual and fixed single veneers, artificial teeth for dental prostheses, which are used for removable permanent full dentures, individual and removable monolithic full and partial dentures in dental laboratories. The material is an alternative to traditional restorative dental material.<br><br>E-Dent 1000 is intended | SprintRay Digital Crown is a light-curable polymerizable resin intended to be used for the fabrication of: individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an | Similar | | | exclusively for professional dental work. Fabrication of dental applications with E-Dent 1000 requires a computer aided and manufacturing (CAD/CAM) system that includes the following components: digital dental files based on a digital impression, or in case of artificial teeth for dental prostheses the digital dental files based on manufacturer's data, a digital light processing (DLP) printer, and curing light equipment. | alternative to traditional restorative dental material. | | | User Population | Clinicians in dental offices | Clinicians in dental offices | Similar | | Chemical Description | Methacrylate-based resin | Methacrylate-based resin | Similar | | Material Type | Light-curable Resin | Light-curable Resin | Similar | | Curing Method | UV Light | UV Light | Similar | | Product State | Liquid | Liquid | Similar | | Manufacturing Technology Type | Additive | Additive | Similar | | Volume provided | 1kg bottle | 1kg bottle | Similar | | Shelf life | >1.5 years | 1.5 years | Similar | | Standards | ISO 10477<br>ISO 4049 | ISO 10477<br>ISO 4049 | Similar | | Physical and Mechanical Properties | Translucency<br><br>Dimensional stability<br><br>Color and color stability<br><br>Flexural Strength and Modulus<br><br>Freedom from Porosity<br><br>Water Sorption and Solubility<br><br>Stability | Shape Capability, Translucency, and Polishability, Radio-opacity<br><br>Print Accuracy and Dimensional Stability<br><br>Color Stability and Shade Consistency<br><br>Flexural Strength and Modulus<br><br>Freedom from Porosity<br><br>Water Sorption and Solubility<br><br>Stability | Similar | | | | Residual Methyl<br>Methacrylate Monomers | | | Biocompatibility | Tested to ISO 7405, ISO-<br>10993-1 | Tested to ISO 7405, ISO-<br>10993-1 | Similar | | | Cytotoxicity (Part 5) | Cytotoxicity (Part 5) | | | | Acute Systematic Toxicity<br>(Part 11) | Acute Systematic Toxicity<br>(Part 11) | | | | Sensitization (Part 10) | Sensitization (Part 10) | | | | Irritation (Part 10) | Irritation (Part 10) | | | | | Genotoxicity (Part 3) | | | Additive<br>Manufacturing | Testing, according to<br>FDA's guidance Technical<br>Considerations for<br>Additive Manufactured<br>Medical Devices, was<br>performed and results<br>were provided in the<br>510(k). These tests<br>included evaluation of all<br>relevant properties of the<br>printed resin using the<br>permitted machines.<br>Further, tests based on<br>considerations of the<br>orientation during<br>manufacturing were<br>performed. | Testing, according to<br>FDA's guidance<br>Technical<br>Considerations for<br>Additive Manufactured<br>Medical Devices, was<br>performed and results<br>were provided in the<br>510(k). These tests<br>included evaluation of<br>all relevant properties<br>of the printed resin<br>using the permitted<br>machines. Further,<br>tests based on<br>considerations of the<br>orientation during<br>manufacturing were<br>performed. | Similar | | Sterility | Non-sterile | Non-sterile | Similar | ### Equivalence to Marketed Devices {6}------------------------------------------------ {7}------------------------------------------------ # Conclusions Digital Crown resin is as safe and effective as its predicate device. Digital Crown resin has the same intended use and indication, and similar technological characteristics, and principles of operation as its predicate device. The minor technological differences between Digital Crown resin and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that Digital Crown resin is as safe and effective as the predicate device. Thus, Digital Crown resin is substantially equivalent.