TERA HARZ

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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. July 15, 2021 Graphy Inc. % Peter Chung Representative Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213 Re: K202846 Trade/Device Name: TERA HARZ Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF, EBG Dated: June 22, 2021 Received: June 23, 2021 Dear Peter Chung: 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, 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K202846 Device Name TERA HARZ Indications for Use (Describe) TERA HARZ is indicated as an indirect restorative for both anterior restorations, including occlusal surfaces. The TERA HARZ material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ 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 For # TERA HARZ ## K202846 [Complying with 21 CFR 807.92] #### l. SUBMISSION SPONSOR Graphy Inc. #603, #617, Ace Gasan Forhu, 225, Gasan digital 1-ro, Geumcheon-gu, Seoul, Republic of Korea Office Phone: 82-2-864-3056 Fax: 82-2-864-3057 Contact Person: Mr. Tae-woo Kim, QMR ### II. SUBMISSION CORRESPONDENT Plus Global 300, Atwood Street, Pittsburgh, PA, 15213, USA Office Phone: 412-687-3976 Contact: Mr. Peter Chung, Representative Email: peterchung210@gmail.com #### III. DATE PREPARED July 12, 2021 ### IV. DEVICE | Trade or Proprietary Name: | TERA HARZ | |----------------------------|------------------------------------------------------------------------------------------------------| | Common or Usual Name: | Preformed Crown and Bridge | | Classification Name: | Tooth shade resin material (21 CFR 872.3690)<br>Crown and Bridge, Temporary, Resin (21 CFR 872.3770) | | Regulatory Class: | II | | Product Code: | EBF, EBG | | Classification Panel: | Dental | #### V. PREDICATE DEVICE Primary Predicate Device: K201668, Tooth shade resin material / BEGO Bremer Goldschlägerei Wilh. Herbst GmbH {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "Graphy" in a bold, sans-serif font. The color of the text is a vibrant orange. The word is presented on a white background, which makes the text stand out. & Co. KG Reference device: K193553, Temporary Crown and Bridge Resin / BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG #### VI. DEVICE DESCRIPTION The TERA HARZ is a light-cured, methacrylate oligomer based polymerizable resin used by dentist or dental technician for the CAD/CAM manufacturing of indirect restorative for both anterior and posterior restorations, including occlusal surfaces, such as temporary or permanent crowns and bridges, inlays, onlays and veneers. Methacrylate based resin is known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical, mechanical and biocompatible properties. The TERA HARZ is made by Methacrylate-based resins. It has stored in a black 1,000g of HDPE bottle. It contains materials with shade A1/A2/A3. This resin is a liquid photopolymer material that is polymerized by UV laser at 405~412nm. the resin can be used to create a customized artificial permanent tooth model with a 3d printer that is cured by ultraviolet light. The liquid UV curing resin is cured at a specific wavelength (395~405nm) by the photo-initiator contained in the resin. Curing in a 3D printer is related to the conditions of the printer equipment, and is typically 100μm in layer thickness, and is output at a resolution of 40 to 90μm on the x, y axis. This device should use specific 3D Printer equipment using UV light source, and it is possible to produce three-dimensional printed matter by curing lamination step by step a thickness of 100μm. However, scanner, design software, 3D printer and post-cure unit are not included with the device. TERA HARZ can be used in combination with specified lasers and DLP based 3D printers which support dental materials. TERA HARZ is a resin for the generative production of permanent or temporary dental restorations based on image projection systems (405-412 nm). The formulation of TERA HARZ is optimized for the requirements of a robust production guaranteeing constant high quality. The TERA HARZ is successfully tested for biocompatibility, certainly meets all mechanical and application demands. The material is used in a 3D printer, which prints the shape determined by a 3D stereolithographic drawing. The material can be used for build processes with layer thicknesses from 25 up to 100 um. After printing, the printed product is recommended to use a UV-light curing for final polymerization. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the word "Graphy" in a bold, sans-serif font. The color of the text is a vibrant orange. The word is presented in a straightforward manner, with each letter clearly legible and evenly spaced. 3D printer is not included with the device. These fabrications of TERA HARZ are beginning with the dental clinician prescribing indirect restorative to treat a patient's both anterior restorations, including occlusal surfaces, and decision to use methacrylate-based resins is made by the dental clinician. TERA HARZ, a permanent or temporary restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations, is manufactured in a 3D printer that is compatible. The dental clinician can generate a digital file by scanning the patient's mouth directly using approved Intraoral scanner software. This digital file is a series of CAD files (.stl) for building models that can be used to fabricate permanent or temporary restorations. Commonly used standard dental software is used by dental professionals to virtually design a restoration and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The design software used is 3D Scanner by 3Shape A/S (510(K) Exempt). The specialized prosthetic treatment planning software has a establishment registration for the intended use under FDA Classification Product Code NOF, regulation 872.3661. This software is used for management of 3D scanned prosthetic models, prosthetic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned prosthetic models, virtual planning of prosthetic treatments by simulating tooth movements, and design of permanent or temporary restorations based on 3D scanned prosthetic models. Once dental clinic manufacturing unit receive the data that *.stl CAD files of crown and bridge the 3D printer begins additive manufacturing. The dental clinician (e.g., dentist) generates sequential 3D printed models replicating the approved treatment plan. The permanent or temporary restorations is 3D printed and cured in a post-curing unit. The fabricated permanent or temporary restorations are cut to fit dentition, the cleaned and polished to remove rough edges by the dental clinician. The prescribing physician review and approves the permanent or temporary restorations are provides them to the patient the confirming fit and design. #### VII. INDICATION FOR USE TERA HARZ is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The TERA HARZ material is used for fabricating permanent or temporary restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and postcure unit. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "Graphy" in a bold, sans-serif font. The color of the text is a vibrant orange. The word is presented in a simple, clean design against a white background. #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VIII. DEVICE The following table compares the TERA HARZ to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device. | | Primary PREDICATE<br>Device (K201668) | REFERENCE Device<br>(K193553) | SUBJECT Device<br>(K202846) | Discussion | |------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | BEGO Bremer<br>Goldschlägerei Wilh.<br>Herbst GmbH & Co.<br>KG | BEGO Bremer<br>Goldschlägerei Wilh.<br>Herbst GmbH & Co.<br>KG | Graphy Inc. | — | | Trade Name | VarseoSmile Crown<br>Plus | VarseoSmile Temp | TERA HARZ | — | | Regulation<br>Description | Tooth shade resin<br>material | Temporary Crown and<br>Bridge Resin | Temporary Crown,<br>Bridge Resin and Tooth<br>Shade | No difference. | | Regulation Number | 21 CFR 872.3690 | 21 CFR 872.3770 | 21 CFR 872.3770<br>21 CFR 872.3690 | No difference. | | Product Code | EBF | EBG | EBG, EBF | No difference. | | Class | II | II | II | No difference. | | Indications for Use | VarseoSmile Crown<br>plus is indicated as an<br>indirect restorative for<br>both anterior and<br>posterior restorations,<br>including occlusal<br>surfaces. The<br>VarseoSmile Crown<br>plus material is used<br>for fabricating<br>permanent<br>restorations such as<br>inlays, onlays, veneers<br>and full crown<br>restorations. | VarseoSmile Temp<br>resin is indicated for<br>the fabrication of<br>temporary dental<br>restorations in<br>conjunction with<br>extraoral light-curing<br>equipment. | TERA HARZ is indicated<br>as an indirect<br>restorative for both<br>anterior and posterior<br>restorations, including<br>occlusal surfaces.<br>The TERA HARZ<br>material is used for<br>fabricating temporary<br>or permanent<br>restorations such as<br>crowns and bridges,<br>inlays, onlays, veneers<br>and full crown<br>restorations.<br>Fabrication of TERA<br>HARZ requires a<br>computer-aided and<br>manufacturing<br>(CAD/CAM) system<br>that includes the<br>following: scanner,<br>design software,<br>additive printer, and<br>post-cure unit. | Similarities: Indication<br>for use of the subject<br>device is slightly<br>different from the<br>primary predicate in<br>phrase but<br>fundamental<br>indication is the<br>identical. | | Manufacturing | 3D liquid (light-cured) | 3D liquid (light-cured) | 3D liquid (light-cured) | No difference. | | | Primary PREDICATE<br>Device (K201668) | REFERENCE Device<br>(K193553) | SUBJECT Device<br>(K202846) | Discussion | | Manufacturer | BEGO Bremer<br>Goldschlägerei Wilh.<br>Herbst GmbH & Co.<br>KG<br>CAD/CAM | BEGO Bremer<br>Goldschlägerei Wilh.<br>Herbst GmbH & Co.<br>KG<br>CAD/CAM | Graphy Inc.<br>CAD/CAM | — | | Material | Methacrylate polymer<br>resin (dimethacrylate) | Methacrylate polymer<br>resin (dimethacrylate) | Methacrylate polymer<br>resin (dimethacrylate) | No difference. | | Material Shades | Common VITA-shades | Common VITA-shades | Common VITA-shades | No difference. | | Biocompatibility | Biocompatible<br>according to ISO<br>10993-1 | Biocompatible<br>according to ISO<br>10993-1 | Biocompatible<br>according to ISO<br>10993-1 | No difference. | | OTC or Rx | Rx | Rx | Rx | No difference. | | Sterile | Non-sterile | Non-sterile | Non-sterile | No difference. | | Chemical Composition | Methacrylate polymer<br>resin with photo<br>initiator, inhibitor and<br>pigments | Methacrylate polymer<br>resin with photo<br>initiator, inhibitor and<br>pigments | Polyurethane Resin;<br>Methacrylate;<br>Dimethacrylate;<br>Phosphine oxide;<br>Butylated<br>hydroxytoluene; and<br>Pigments | Similarities: The<br>subject and predicate<br>or reference devices<br>are very similarities in<br>they are all polymer<br>resins. Slight<br>differences in chemical<br>composition do not<br>change the intended<br>use of the subject,<br>predicate and<br>reference devices to<br>be used in the<br>fabrication of dental<br>prostheses. The<br>material is an<br>alternative to<br>traditional heat cured<br>and auto<br>polymerization resins. | | Flexural Strength<br>(≥100 MPa; ISO 4049,<br>≥50 MPa; ISO 10477) | ≥ 100 MPa | ≥100 MPa | Avg. 148.73 MPa | Similarities: the<br>specifications are in<br>the same range. This<br>minor variance does<br>not introduce<br>additional safety or<br>efficacy concerns.<br>Both devices meet<br>requirements from ISO<br>4049:2019 and ISO<br>14077:2018. | | Water sorption (≤40<br>µg/mm³) | ≤40 µg/mm³ | ≤40 µg/mm³ | Avg. 13.03 µg/mm³ | Similarities: the<br>specifications are in<br>the same range. This<br>minor variance does<br>not introduce<br>additional safety or<br>efficacy concerns. | | | Primary PREDICATE<br>Device (K201668) | REFERENCE Device<br>(K193553) | SUBJECT Device<br>(K202846) | Discussion | | Manufacturer | BEGO Bremer<br>Goldschlägerei Wilh.<br>Herbst GmbH & Co.<br>KG | BEGO Bremer<br>Goldschlägerei Wilh.<br>Herbst GmbH & Co.<br>KG | Graphy Inc. | — | | | | | | requirements from ISO<br>4049:2019 and ISO<br>14077:2018. | | Solubility (≤7.5<br>µg/mm³) | ≤7.5 µg/mm³ | ≤7.5 µg/mm³ | Avg. 1.00 µg/mm³ | Similarities: the<br>specifications are in<br>the same range. This<br>minor variance does<br>not introduce<br>additional safety or<br>efficacy concerns.<br>Both devices meet<br>requirements from ISO<br>4049:2019 and ISO<br>14077:2018. | {7}------------------------------------------------ # Graphy {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "Graphy" in a bold, sans-serif font. The color of the text is a vibrant orange. The word is presented on a white background, which makes the text stand out. #### IX. NON-CLINICAL PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. #### Manufacturing Validation A manufacturing validation was performed to demonstrate the manufacturing process for TERA HARZ. An independent 3rd party software and digital calipers were used to perform point-topoint and critical displacement measurement. All translational measurements were within 0.150 mm of the target input value, the predefined tolerance of the manufacturing process. There were no statistical differences in the difference in the intended and measured values observed from any of the groups. This test has met the pre-established acceptance criteria. And the test also conducted studies on the effect of manufacturing validation and material reuse on the properties of the final finished device according to FDA's published guidance documents, "Technical Considerations for Additive Manufactured Medical Devices". The TERA HARZ were outputted by each different output condition and each flexural strength were measured and the evaluation criteria of the all the specimens were more than 50 MPa. The optimal output condition is that the output angle is 0°, and the output position is centered to confirming that the optimal condition is to be output. In addition, it was confirmed that there was no problem in the number of effective outputs for repeated material output up to 7 times. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the word "Graphy" in a bold, sans-serif font. The color of the text is a vibrant orange. The word is presented in a simple, clean design against a white background. #### Performance Testing The predicate/reference devices performed tests for Flexural Strength, Flexural Modulus, Water Solubility, Water Sorption, and Biocompatibility content. The predicate/reference devices performed these tests as well and all met the requirements of ISO 4049:2013, Dentistry - Polymer-based restorative materials, and ISO 10477:2018, Dentistry -Polymer-based crown and veneering materials. #### Biocompatibility A biocompatibility discussion was conducted. The TERA HARZ uses the Dimethacrylatebased resins and this material has been tested and shown to be compliant with the following standards: - । ISO 7405:2018, Dentistry – Evaluation of biocompatibility of medical devices used in dentistry - । ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Evaluation and testing - । ISO 10993-3:2014, Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity - -ISO 10993-5:2009, Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity - । ISO 10993-6:2016, Biological evaluation of medical devices – Part 6: Tests for local effects after implantation - । ISO 10993-10:2010, Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization - । ISO 10993-11:2017, Biological evaluation of medical devices – Part 11: Tests for systemic toxicity ### X. CLINICAL DATA The performance of methacrylate-based polymer resins in the clinical environment has been well established. No clinical data is included in this submission. #### XI. CONCLUSIONS The TERA HARZ is very similar to both predicate devices and demonstrate substantial equivalence to predicate/reference devices K201668 and K193553. An analysis for subject device compared to the predicate device show TERA HARZ and the Resin for Temporary Crown & Bridge meet all two devices share the same product code, meet the requirements, and all two are biocompatible. In addition, an analysis for subject device compared to the predicate device show TERA HARZ and the Resin for Temporary Crown & Bridge meet the requirements of ISO 10477:2018, Dentistry - Polymer-based crown and veneering materials and ISO 4049:2013, Dentistry - Polymer-based restorative materials. All two devices meet or {10}------------------------------------------------ Image /page/10/Picture/0 description: The image contains the word "Graphy" in a bold, sans-serif font. The color of the text is a vibrant orange. The word is presented in a simple, clean design, with each letter clearly legible. exceed the minimum strength requirements, and all two are biocompatible. Any differences between subject device and the predicate devices are minimal and present no new risks.