FREEPRINT crown

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September 23, 2022 DETAX GmbH % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114 Re: K222877 Trade/Device Name: FREEPRINT crown Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: Class II Product Code: EBF, EBG Dated: August 5, 2022 Received: September 22, 2022 ## Dear Prithul Bom: 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) K222877 Device Name FREEPRINT® crown #### Indications for Use (Describe) FREEPRINT® crown is indicated as an indirect restorative for both anterior restorations. including occlusal surfaces. The FREEPRINT® crown material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of FREEPRINT® crown requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit. | 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}------------------------------------------------ ## 510(k) Summary DETAX GmbH FREEPRINT® crown 9/13/2022 #### ADMINISTRATIVE INFORMATION | Manufacturer Name: DETAX GmbH<br>Carl-Zeiss-Strasse 4<br>D-76275 Ettingen, Germany<br>Telephone: +49 7243/510-138 | Consultant: Aclivi, LLC<br>3250 Brackley Drive<br>Ann Arbor, Michigan 48105<br>Telephone: +1 810 360-9773 | |-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| | Official Contact: Markus Stratmann - Divisional Director 3D<br>Email: Markus.Stratmann@detax.de | Chris Brown - Manager<br>acliviconsulting@gmail.com | #### DEVICE NAME AND CLASSIFICATION | Trade/Proprietary Name: | FREEPRINT® crown | |-------------------------|----------------------------------------------------------------------------------------------| | Regulation Name: | Material, Tooth Shade, Resin | | Regulation Number: | 21 CFR 872.3690 | | Device Class: | Class II | | Product Code: | EBF | | Review Panel: | Dental | | Reviewing Branch: | Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)<br>Dental Devices (DHT1B) | #### PREDICATE DEVICE INFORMATION K201668 The Subject device in this submission is substantially equivalent in indications, use and design principles to the following Predicate device. | 510(k) | Predicate Device Name | Company Name | |---------|-----------------------|----------------------------------| | K202846 | TERA HARZ | Graphy Inc | | 510(k) | Reference Device Name | Company Name | | | | BEGO Bremer Goldschlägerei Wilh. | Herbst GmbH & Co. KG #### INDICATIONS FOR USE FREEPRINT® crown is indicated as an indirect restorative for both anterior restorations, including occlusal surfaces. VarseoSmile Crown Plus The FREEPRINT® crown material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of FREEPRINT® crown requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit. #### DEVICE DESCRIPTION The Subject device is a light-cured methacrylate-based resin used in 3D printers for the production of temporary or permanent dental restorations such as crowns and bridges, inlays, veneers and full crown restorations {4}------------------------------------------------ including occlusal surfaces. The Subject device is used by a dental technician for the CAD/CAM manufacturing of temporary dental restorations. Restorations fabricated using the Subject device are one-time use, prescription-only devices. The Subject device is a viscous solution consisting of methacrylate-based resins, photo initiators and pigments. Commonly used dental CAD software is used by dental professionals to virtually design a fixed indirect restoration and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The Subject resin is used within a validated manufacturing workflow to create the intended restoration. The Subject device is available in a variety of optional shades to reproduce the intended tooth shade of the restoration. Methacrylates are known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical, mechanical, and biocompatible properties. The Subject device is intended to be sold by the bottle and used with compatible hardware in computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit. ### EQUIVALENCE TO MARKETED DEVICE The Subject device is highly similar to the Predicate device with respect to Indications for Use and technological principles. The comparison tables below compare the Indications for Use and Technological Characteristics of the Subject, Predicate and Reference devices. | Device | Indications for Use Statement | |------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Subject Device<br>FREEPRINT® crown<br>DETAX GmbH | FREEPRINT® crown is indicated as an indirect restorative for both anterior and posterior<br>restorations, including occlusal surfaces.<br><br>The FREEPRINT® crown material is used for fabricating temporary or permanent restorations such<br>as crowns and bridges, inlays, onlays, veneers and full crown restorations.<br><br>Fabrication of FREEPRINT® crown requires a computer-aided and manufacturing (CAD/CAM)<br>system that includes the following: scanner, design software, additive printer, and post-cure unit. | | Predicate Device<br>TERA HARZ (K202846)<br>Graphy Inc | TERA HARZ is indicated as an indirect restorative for both anterior and posterior restorations,<br>including occlusal surfaces.<br><br>The TERA HARZ material is used for fabricating temporary or permanent restorations such as<br>crowns and bridges, inlays, onlays, veneers and full crown restorations.<br><br>Fabrication of TERA HARZ requires a computer-aided and manufacturing (CAD/CAM) system that<br>includes the following: scanner, design software, additive printer, and post-cure unit. | | Reference Device<br>VarseoSmile Crown Plus (K201668)<br>BEGO Bremer Goldschlägerei Wilh. Herbst<br>GmbH & Co. KG | VarseoSmile Crown plus is indicated as an indirect restorative for both anterior and posterior<br>restorations, including occlusal surfaces. The VarseoSmile Crown plus material is used for fabricating<br>permanent restorations such as inlays, onlays, veneers and full crown restorations. | ### Indications For Use The Subject and Predicate Indications for Use Statement (IFUS) are highly similar, differing only by the device name. The Reference device IFUS is similar in wording, with a similar usage of the material, but focusing only on permanent restorations. Slight differences in the wording of the device name within Indications for Use Statements does not change the intended use of the Subject and Predicate devices to fabricate temporary or permanent dental restorations. {5}------------------------------------------------ # Technological Characteristics | | Subject Device | Predicate Device | Reference Device | Comparison with<br>Predicate Device | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------| | | FREEPRINT® crown<br>DETAX GmbH | TERA HARZ ( K202846)<br>Graphy Inc | VarseoSmile Crown Plus (K201668)<br>BEGO Bremer Goldschlägerei Wilh.<br>Herbst GmbH & Co. KG | | | Parameter | | | | | | Reason for<br>Predicate/Reference | n/a | IFUS, Technological Characteristics | Comparative Bench<br>Performance Testing | Same | | Product Code | EBF | EBF, EBG | EBF | Same | | Regulation Number | 872.3690 | 872.3690 | 872.3690 | Same | | Regulatory Class | Class II | Class II | Class II | Same | | | FREEPRINT® crown is indicated as an<br>indirect restorative for both anterior and<br>posterior restorations, including occlusal<br>surfaces. | TERA HARZ is indicated as an<br>indirect restorative for both anterior<br>and posterior restorations, including<br>occlusal surfaces. | VarseoSmile Crown plus is<br>indicated as an indirect<br>restorative for both anterior and<br>posterior restorations, including<br>occlusal surfaces. The | Highly Similar | | | The FREEPRINT® crown material is used<br>for fabricating temporary or permanent<br>restorations such as crowns and bridges,<br>inlays, onlays, veneers and full crown<br>restorations. | The TERA HARZ material is used for<br>fabricating temporary or permanent<br>restorations such as crowns and<br>bridges, inlays, onlays, veneers and<br>full crown restorations. | VarseoSmile Crown plus material<br>is used for fabricating<br>permanent restorations such as<br>inlays, onlays, veneers and full<br>crown restorations. | | | Intended Use | Fabrication of FREEPRINT® crown<br>requires a computer-aided and<br>manufacturing (CAD/CAM) system that<br>includes the following: scanner, design<br>software, additive printer, and post-cure<br>unit. | Fabrication of TERA HARZ requires a<br>computer-aided and manufacturing<br>(CAD/CAM) system that includes the<br>following: scanner, design software,<br>additive printer, and post-cure unit. | | | | Technology | 3D liquid (light-cured) print resin for<br>dental CAD/CAM | 3D liquid (light-cured) print resin for<br>dental CAD/CAM | 3D liquid (light-cured) print resin<br>for dental CAD/CAM | Same | | Material | Methacrylate polymer resin<br>(includes dimethacrylate) | Methacrylate polymer resin<br>(dimethacrylate) | Methacrylate polymer resin<br>(dimethacrylate) | Highly Similar | | Material Shades | Common VITA-shades:<br>A1, A2, A3, B1, B3, C3, D3, BL | Common VITA-shades | Common VITA-shades | Highly Similar | | Biocompatible | Yes | Yes | Yes | Same | | OTC or Rx | Rx | Rx | Rx | Same | | Sterile | Non-sterile | Non-sterile | Non-sterile | Same | | Shelf-Life | 2 years | Not defined | Not defined | Not applicable | | Chemical Composition | Methacrylate polymer resin with photo<br>initiator, and pigments | Polyurethane Resin; Methacrylate;<br>Dimethacrylate; Phosphine oxide;<br>Butylated hydroxytoluene; and<br>Pigments | (Meth)acrylate-based resin with<br>photo initiator and pigments | Highly Similar | | Polymerization (Curing)<br>Method | Visible light, 385 nm<br>w/post curing | UV light, 405~412nm<br>w/post curing | UV light, 405 nm<br>w/post curing | Highly Similar | | Equipment | Validated 3D-Printer and post curing<br>devices | Validated 3D-Printer and post curing<br>devices | Validated 3D-Printer and post<br>curing devices | Same | | Performance Testing | ISO 4049:2019<br>ISO 10477:2020 | ISO 4049:2013<br>ISO 10477:2018 | ISO 4049:2013<br>ISO 10477:2018 | Highly Similar | | Depth of Cure | Hardness of bottom surface ≥70% top<br>surface | Not defined | Not defined | Highly Similar (meets requirements<br>of ISO 4049 and ISO 10477) | | Surface Finish | Glossy surface after polishing | Not defined | Not defined | Highly Similar (meets requirements<br>of ISO 4049 and ISO 10477) | | Flexural Strength | $≥ 100 MPa$ | Avg. 148.73 MPa | $≥ 100 MPa$ | Highly Similar (meets requirements<br>of ISO 4049 and ISO 10477) | | Water Sorption | $≤ 40 µg/mm3$ | Avg. 13.03 µg/mm3 | $≤ 40 µg/mm3$ | Highly Similar (meets requirements<br>of ISO 4049 and ISO 10477) | | Water Solubility | $≤ 7.5 µg/mm3$ | Avg. 1.00 µg/mm3 | $≤ 7.5 µg/mm3$ | Highly Similar (meets requirements<br>of ISO 4049 and ISO 10477) | | Biocompatibility Testing | ISO 7405:2018<br>ISO 10993-1:2018<br>ISO 10993-3:2014<br>ISO 10993-5:2009<br>ISO 10993-10:2021<br>ISO 10993-11:2017<br>ISO 10993-17:2002<br>ISO 10993-18:2020 | ISO 7405:2014<br>ISO 10993-1:2018<br>ISO 10993-3:2014<br>ISO 10993-5:2009<br>ISO 10993-6:2016<br>ISO 10993-10:2013<br>ISO 10993-11:2017 | Tested<br>Standards not listed in 510(k)<br>Summary document. | Highly Similar | {6}------------------------------------------------ The Technological Characteristics of the Subject and Predicate devices are the Same or Highly Similar. Intended Use - The Subject and Predicate devices are same Highly Similar in their intended use, differing only in reference to the device name. Material/Chemical Composition - The Subject and Predicate devices are same Highly Similar in they are both methacrylate polymer resins. Slight differences in chemical composition do not change the intended use of the Subject and Predicate devices to be used in the fabrication of permanent or temporary dental prostheses. The materials are an alternative to traditional heat cured and auto polymerization resins. The Subject device has demonstrated suitability for intended use through material non-clinical performance testing. Polymerization (Curing) Method - The Subject and Predicate devices are same Highly Similar in they are both light-cured polymer resins. Slight differences in the curing light wavelength does not changed use of the Subject and Predicate devices to be used in the fabrication of dental prostheses. Performance Testing - The material performance standards used for testing the Subject and Predicate devices are highly similar, differing only in release date of the Subject device was tested to the most recent versions of ISO 4049 and ISO 10477. The material performance requirements of both standards did not change in the new release dates of each document. The Subject, Predicate and Reference devices all meet the material performance requirements of both the ISO 4049 and ISO 10477 documents. Biocompatibility - The Subject and Predicate devices are similar in the standards and biological endpoints the devices were evaluated to. Slight differences in the standards and tested endpoints do not change the intended use of the Subject and Predicate devices. Technological differences between the Subject and Predicate devices have been evaluated through non-clinical performance testing. The results of the tests performed show that Subject device meets the requirements mentioned in the applicable standards and confirm that the Subject device performs similarly to Predicate and Reference devices. ### CLINICAL AND ANIMAL TESTING The performance of methacrylate-based polymer resins in the clinical environment has been well established. No clinical or animal testing data is included in this submission. ### NON-CLINICAL PERFORMANCE TESTING Validation of the manufacturing process and compatible equipment was performed demonstrating consistency of the process output with that of the process input. Physical property testing was performed on the Subject device to ISO 4049:2019, Dentistry — Polymer-based restorative materials and ISO 10477:2018, Dentistry – Polymer-based crown and veneering materials. Results {7}------------------------------------------------ demonstrated the Subject device meets the property requirements of the referenced standards. Comparative material property testing was performed with the Reference device demonstrating similar performance. A biological evaluation was performed on the Subject device. Chemical characterization was performed to ISO 10993-18 with a risk assessment performed according to ISO 10993-17 and ISO/TS 21726. Biocompatibility testing was performed on the Subject device according to ISO 10993-1:2018 and ISO 7405:2014 according to the standards listed in the Technological Characteristics comparison table above. An MRI safety assessment was performed on the Subject device to support MR Safety labeling as required by the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment". Non-clinical performance testing of the Subject device met the acceptance criteria for each validation and test described above. This non-clinical performance testing demonstrates that the Subject device is suitable for intended use. ### CONCLUSION Overall, the Indications for Use statements for the Subject and Predicate devices are highly similar differing only in device name and slightly in use duration. Overall, the Technological Characteristics of the Subject device are the same or highly similar to the Predicate device with any differences mitigated through nonclinical performance testing. Overall, these similarities between the Subject and Predicate devices, support a determination of substantial equivalence.