TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000)

{0} **U.S. FOOD & DRUG** ADMINISTRATION November 21, 2025 Graphy Inc. % Dave Yungvirt CEO Third Party Review Group, LLC 7 Giralda Farms, Suite 120A Madison, New Jersey 07940 Re: K253681 Trade/Device Name: TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000) Regulation Number: 21 CFR 872.3760 Regulation Name: Denture relining, repairing, or rebasing resin Regulatory Class: Class II Product Code: EBI Dated: November 20, 2025 Received: November 21, 2025 Dear Dave Yungvirt: 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 (the 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 available 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K253681 - Dave Yungvirt Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the {2} K253681 - Dave Yungvirt Page 3 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-devices/device-advice-comprehensive-regulatory-assistance/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 -S Michael E. Adjodha, MChE, RAC, 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 {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # **Indications for Use** Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K253681 Device Name TERA HARZ HARD DENTURE Indications for Use (Describe) The TERA HARZ HARD DENTURE is a light-curable resin indicated for the fabrication and repair of full and partial removable dentures (HARD-type) and base plates. The material is an alternative to traditional heat-curable and autopolymerizing resins. Fabrication of dental prosthetics with the TERA HARZ HARD DENTURE requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on a digital impression, a DLP, SLA, or LCD additive 3D printer, and a post-curing unit. 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."* FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} Graphy Inc. Traditional 510(k) Premarket Submission TERA HARZ HARD DENTURE K253681 ### 510(k) Summary For ### TERA HARZ HARD DENTURE ### [Complying with 21 CFR 807.92] ### I. 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. Moon-Soo Park / RA Manager ### II. SUBMISSION CORRESPONDENT ### III. DATE PREPARED 20 November 2025 ### IV. DEVICE Trade or Proprietary Name: TERA HARZ HARD DENTURE Model name : THD-C500, THD-C1000, THD-LP500, THD-LP1000, THD-P500, THD-P1000, THD-CP500, THD-CP1000 Common or Usual Name: Denture Base Resin Classification Name: Denture relining, repairing, or rebasing resin. (872.3760) Regulatory Class: II Product Code: EBI Classification Panel: Dental ### V. PREDICATE DEVICE Primary Predicate Device: K222414, TERA HARZ DENTURE / Graphy Inc. (Class II) Reference Device. K202846, TERA HARZ / Graphy Inc. (Class II) Page 1-12 {5} Graphy Inc. Traditional 510(k) Premarket Submission TERA HARZ HARD DENTURE # VI. DEVICE DESCRIPTION The TERA HARZ HARD DENTURE is a light-cured, methacrylate-based resin commonly used in additive manufacturing when producing dental structures (both full and partial dentures-Hard type). Methacrylate-based resin is a known material that is often used in the dental industry for fixed and removable prosthetic devices due to its physical-chemical, mechanical, and biocompatible properties. The TERA HARZ HARD DENTURE is made from methacrylate-based resins. It is stored in a black 1,000g HDPE bottle. This resin is a liquid photopolymer material that is polymerized by a ultraviolet (UV) laser at 405~412 nm. The resin can be used to create customized removable full and partial dentures with a 3D printer cured by UV light. The UV curable liquid resin is cured at a specific wavelength (405 nm) by the photo-initiator contained in the resin. The process parameters of the 3D printer affect the quality of the 3D printed objects. The printer equipment should be set to a resolution of 40 to 90 µm on the x,y axis (horizontal resolution) and 100 µm on the z axis (vertical resolution). The TERA HARZ HARD DENTURE should be used with a specific 3D printer that uses a UV light source and produces 3D printed objects with layer thickness of 100 µm(recommended). The TERA HARZ HARD DENTURE does not come with a Intraoral scanner, design software, 3D printer, or post-cure unit. The TERA HARZ HARD DENTURE can be used to manufacture customized removable full and partial dentures using compatible equipment. Digital files can be generated by scanning the patient's intraoral region directly with an intraoral scanner or by scanning the teeth model with a model intraoral scanner under the FDA Classification Product Code NOF, regulation 872.3661. The digital file consists of a series of CAD files (stl) for building 3D models that can be used to create the denture base. Specialized dental software is used to virtually design a denture base and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The design software used is 3Shape Dental System™ under the FDA Classification Product Code NOF, regulation 872.3661. This software is used to manage 3D scanned teeth models, as well as to measure, analyze, examine, and visualize 3D scanned teeth models to design denture models. STL files are transferred to a 3D printer. Using the *.stl CAD file data, the 3D printer Page 2-12 {6} Graphy Inc. Traditional 510(k) Premarket Submission TERA HARZ HARD DENTURE begins additive manufacturing, which is used to create customized 3D printed dentures. The 3D printed dentures are further cured in the post-curing device. Manufactured dentures are polished and washed accordingly. Before giving the dentures to the patients, the dentist reviews them to ensure the optimal fit and design. # **Accessories for the Product, Integral Parts of Package** Not applicable, This device does not come with a compatible intraoral or model scanners, design software, 3D printers, post-cure unit, and other accessories used in fabrication. # **VII. INDICATION FOR USE** The TERA HARZ HARD DENTURE is a light-curable resin indicated for the fabrication and repair of full and partial removable dentures (HARD-type) and base plates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with the TERA HARZ HARD DENTURE requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on a digital impression, a DLP, SLA, or LCD additive 3D printer, and a post-curing unit. # **VIII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE** To demonstrate safety and effectiveness of the TERA HARZ HARD DENTURE and to show substantial equivalence to the predicate device, the following non-clinical tests were completed: Flexural Strength/Modulus, Water sorption, and Solubility. The result of the performance comparison test demonstrates that the TERA HARZ HARD DENTURE is substantially equivalent to the predicate device. Potential minor variance does not introduce additional safety or efficacy concerns. Both devices meet requirements from ISO 20795-1:2013. The performance characteristics of the TERA HARZ HARD DENTURE are comparable to those of the predicate device for this particular indication and raise no questions on safety and effectiveness. Any differences in technology characteristics are accompanied by information that Page 3-12 {7} Graphy Inc. Traditional 510(k) Premarket Submission TERA HARZ HARD DENTURE demonstrates that the device is as safe and as effective as the predicate device and do not raise questions on safety and effectiveness. Therefore, it is concluded that the technological differences do not raise questions on safety and effectiveness. Comparison table: Subject device with Predicate device | | SUBJECTDevice | PREDICATE Device | Significant Difference | | --- | --- | --- | --- | | Manufacturer | Graphy Inc. | Graphy Inc. | - | | TradeName | TERA HARZ HARD DENTURE | TERA HARZ DENTURE | - | | 510(k) No. | - | K222414 | - | | Regulation Description | Resin, Denture, Relining, Repairing, Rebasing | Resin, Denture, Relining, Repairing, Rebasing | Same | | Regulation Number | 21 CFR 872.3760 | 21 CFR 872.3760 | Same | | Product Code | EBI | EBI | Same | | Class | II | II | Same | | Indications for Use | The TERA HARZ HARD DENTURE is a light-curable resin indicated for the fabrication and repair of full and partial removable dentures (HARD-type) and base plates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with the TERA HARZ HARD DENTURE requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on a digital impression, a DLP, SLA, or LCD additive 3D printer, and a post-curing unit. | The TERA HARZ DENTURE is a light- curableresin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with the TERA HARZ DENTURE requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on digital impression, DLP,SLA,LCD method additive 3d printer, and post-curing light equipment | Same | | Fabrication of Denture Base | Automated 3D printing(DLP,SLA,LCD) of resin in multiple layers, each light-cured before adding next layer, with post | Automated 3D printing(DLP,SLA,LCD) of resin in multiple layers, each light-cured before adding next layer, with post | Same | Page 4-12 {8} Graphy Inc. Traditional 510(k) Premarket Submission TERA HARZ HARD DENTURE | | curing in light chamber | curing in light chamber | | | --- | --- | --- | --- | | Device Characteristics | Digital Scan file: STL Design software: 3shape dental system (NOF) Additive 3D printer: DLP/SLA/LCD method -SPRINTRAY PRO 95 -UNIZ NBEE Post-Curing equipment: -Tera Harz Cure (THC) | Digital Scan file: STL Design software: 3shape dental system (NOF) Additive 3D printer: DLP/SLA/LCD method -SPRINTRAY PRO 95 -UNIZ NBEE Curing equipment: -Tera Harz Cure (THC) | Same | | Device color | - Clear - Light pink - Pink - Coral Pink | - Clear - White - Light pink - Pink - Dark pink - Black pink | Different : The color for these two products is slightly different. But this differences not introduce additional safety of efficacy concerns. | | Materials of Use | Methacrylate-based resins with photo-initiator, inhibitor and pigments | Methacrylate-based resins with photo-initiator, inhibitor and pigments | Different : the subject device differs from the predicate device in the material of use. The two products are similar methacrylate-based resins, but they differ in raw material composition. | | Product State | Pre-mixed resin (liquid) | Pre-mixed resin (liquid) | Same | | Design | | | Same | | Performance Testing | ISO 20795-1:2013 Requirements: Visual inspection item | ISO 20795-1:2013 Requirements: Visual inspection item | Different: The SUBJECT Device has higher Flexural strength, | Page 5-12 {9} Graphy Inc. Traditional 510(k) Premarket Submission TERA HARZ HARD DENTURE | | (surface characteristics, shape capability, colour, colour stability, translucency, freedom of porosity) -Residual methyl methacrylate monomer - Flexural strength > 65 MPa. - Flexural modulus > 2,000 MPa. - Water sorption ≤ 32 μg/mm³ - Water solubility ≤ 1.6 μg/mm³ - Maximum stress intensity factor ≥ 1.9 MPa m1/2. - Total fracture work ≥ 900 J/m2 Test Results: -Visual inspection item : All meets the criteria - Residual methyl methacrylate monomer : 0.0% - Average Flexural strength = MPa Avg: 123 MPa (DLP) Avg: 122 MPa (SLA) Avg: 115 MPa (LCD) - Flexural modulus: Average MPa Avg: 3107 MPa (DLP) Avg: 3029 MPa (SLA) Avg: 2827 MPa (LCD) - Average Water sorption=μg /mm³ Avg: 17 μg/mm³ (DLP) Avg: 16 μg/mm³ (SLA) Avg: 17 μg/mm³ (LCD) | (surface characteristics, shape capability, colour, colour stability, translucency, freedom of porosity) -Residual methyl methacrylate monomer - Flexural strength > 65 MPa. - Flexural modulus > 2,000 MPa. - Water sorption ≤ 32 μg/mm³ - Water solubility ≤ 1.6 μg/mm³ - Maximum stress intensity factor ≥ 1.9 MPa m1/2. - Total fracture work ≥ 900 J/m2 Test Results: -Visual inspection item : All meets the criteria - Residual methyl methacrylate monomer : 0.0% - Average Flexural strength = MPa Avg: 116 MPa (DLP) Avg: 112 MPa (SLA) Avg: 108 MPa (LCD) - Flexural modulus: Average MPa Avg: 3092 MPa (DLP) Avg: 3001 MPa (SLA) Avg: 2903 MPa (LCD) - Average Water sorption=μg /mm³ Avg: 9 μg/mm³ (DLP) Avg: 8.5 μg/mm³ (SLA) Avg: 8.6 μg/mm³ (LCD) | Flexural modulus, and Water solubility than the PREDICATE Device.There was no significant difference in their performance testing results between the two devices, and they all satisfied the required standards according to ISO 20795-1:2013. | | --- | --- | --- | --- | Page 6 / 12 {10} Graphy Inc. Traditional 510(k) Premarket Submission TERA HARZ HARD DENTURE | | - Average Water solubility =μg/mm³ Avg: 0.6 μg/mm³ (DLP) Avg: 0.6 μg/mm³ (SLA) Avg: 0.8 μg/mm³ (LCD) -Average maximum stress intensity factor = MPa m1/2 Avg: 2.08 MPa m1/2 (DLP) Avg: 2.08 MPa m1/2 (SLA) Avg: 2.05 MPa m1/2 (LCD) -Average total fracture work = (J/m2) Avg: 1055 (J/m2) (DLP) Avg: 1068 (J/m2) (SLA) Avg: 1056 (J/m2) (LCD) | - Average Water solubility =μg/mm³ Avg: 0.6 μg/mm³ (DLP) Avg: 0.6 μg/mm³ (SLA) Avg: 0.8 μg/mm³ (LCD) -Average maximum stress intensity factor = MPa m1/2 Avg: 2.37 MPa m1/2 (DLP) Avg: 2.33 MPa m1/2 (SLA) Avg: 2.33 MPa m1/2 (LCD) -Average total fracture work = (J/m2) Avg: 1651 (J/m2) (DLP) Avg: 1604 (J/m2) (SLA) Avg: 1626(J/m2) (LCD) | | | --- | --- | --- | --- | | **Biocompatibility** | Biocompatibility tests were conducted according to ISO 10993-1 | Biocompatible according to ISO 10993-1 | **Same** | | **Sterile** | To be used Non-sterile | To be used Non-sterile | **Same** | | **Shelf-life** | 2 years | 2 years | **Same** | Page 7 / 12 {11} Graphy Inc. Traditional 510(k) Premarket Submission TERA HARZ HARD DENTURE Comparison table: Subject device with Reference device | | SUBJECT Device | Reference Device | Significant Difference | | --- | --- | --- | --- | | Manufacturer | Graphy Inc. | Graphy Inc. | - | | Trade Name | TERA HARZ HARD DENTURE | TERA HARZ | - | | 510(k) No. | - | K202846 | - | | Regulation Description | Resin, Denture, Relining, Repairing, Rebasing | -Tooth shade resin materials - Crown and Bridge, Temporary, Resin | Different | | Regulation Number | 21 CFR 872.3760 | -21 CFR 872.3690 -21 CFR 872.3770 | Different | | Product Code | EBI | EBF EBG | Different | | Class | II | II | Same | | Indications for Use | The TERA HARZ HARD DENTURE is a light-curable resin indicated for the fabrication and repair of full and partial removable dentures (HARD-type) and base plates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with the TERA HARZ HARD DENTURE requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on a digital impression, a DLP, SLA, or LCD additive 3D printer, and a post-curing unit. | 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 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 tha includes the following: Intraoral scanner, design software, additive 3d printer, and post-cure unit. | Different | | Manufacturing Technology | Additive 3d printing (DLP,SLA,.LCD method) | Additive 3d printing (DLP,SLA,.LCD method) | Same | Page 8 / 12 {12} Graphy Inc. Traditional 510(k) Premarket Submission TERA HARZ HARD DENTURE | **Device Characteristics** | Digital Scan file: STL Design software: 3shape dental system (NOF) Additive 3D printer: DLP/SLA/LCD method -SPRINTRAY PRO 95 -UNIZ NBEE Post-Curing equipment: -Tera Harz Cure (THC) | Digital Scan file: STL Design software: 3shape dental system (NOF) Additive 3D printer: DLP/SLA/LCD method -SPRINTRAY PRO 95 -UNIZ NBEE Curing equipment: -Tera Harz Cure (THC) | **Same** | | --- | --- | --- | --- | Page 9 / 12 {13} Graphy Inc. Traditional 510(k) Premarket Submission TERA HARZ HARD DENTURE | Materials of Use | Methacrylate-based resins with photo-initiator, inhibitor and pigments | Methacrylate-based resins with photo-initiator, inhibitor and pigments | Same : The subject device and the reference device have the same raw material. | | --- | --- | --- | --- | | Product State | Pre-mixed resin (liquid) | Pre-mixed resin (liquid) | Same | | Design | | | Different | | Performance Testing | - ISO 20795-1:2013 | ISO 10477:2020 | Difference:The subject device and the reference device applied different technical standards. | | Biocompatibility | Biocompatible according to ISO 10993-1-Cytotoxicity-Sensitization-Oral irritation-Intracutaneous reactivity-Acute systemic toxicity-Subchronic Toxicity-Genotoxicity-Genotoxicity (In Vitro)-Implantation | Biocompatible according to ISO 10993-1-Cytotoxicity-Sensitization-Oral irritation-Intracutaneous reactivity-Acute systemic toxicity-Subchronic Toxicity-Genotoxicity-Genotoxicity (In Vitro)-Implantation | Same | | Sterile | To be used Non-sterile | To be used Non-sterile | No difference | | Shelf-life | 2 years | 2 years | No difference | Page 10 / 12 {14} Graphy Inc. Traditional 510(k) Premarket Submission TERA HARZ HARD DENTURE # IX. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. # Manufacturing Validation A manufacturing validation was performed with the following printer(s) to demonstrate the manufacturing process for the TERA HARZ HARD DENTURE: | | Manufacturer | Brand(Model) | Remark | | --- | --- | --- | --- | | Design: | | | | | Intraoral scanner | 3Shape A/S | TIROS 3 Basic TRIOS 4 TRIOS 5 | | | Design software | 3Shape A/S | 3 Shape Dental System™ | | | Additive Manufacturing System: | | | | | 3D Printer | SprintRay Inc. | Pro 95 | | | | UNIZ TECHNOLOGY LLC. | NBEE | | | Post-Curing: | | | | | Post-cure unit | Graphy Inc. | Tera Harz Cure(THC) | | The equipment in this table has been validated by the manufacturer. The test was conducted to evaluate the effect of manufacturing validation and material reuse on the properties of the final finished device according to the FDA's published guidance document, "Technical Considerations for Additive Manufactured Medical Devices". The test specimens made of TERA HARZ HARD DENTURE were printed under different output conditions and each specimen was measured using the evaluation criteria of a flexural strength greater than 65 MPa and flexural modulus greater than 2000 MPa. All specimens met the criteria. The optimal output angle is 45 degrees, and the optimal position is the center. In addition, the repeated usage of the resin met the acceptance criteria for flexural strength and modulus when reused up to 6 times. # Performance Testing Performance tests in accordance with ISO 20795-1 including visual inspection, capacity, package integrity, surface characteristics, shape capability, porosity, translucency, color, color stability, flexural strength, flexural modulus, water sorption, water solubility, total fracture work, maximum stress intensity factor were performed. The results of the non- Page 11 / 12 {15} Graphy Inc. Traditional 510(k) Premarket Submission TERA HARZ HARD DENTURE clinical tests demonstrate that the results have met the standard criteria, and the subject device is substantially equivalent to the predicate device. # Shelf Life Testing The shelf-life of the subject device is 2 years. Accelerated Shelf life testing has been conducted with bench tests according to the ISO 20975-1:2013. # Biocompatibility Biocompatibility Tests in accordance with the FDA Guidance Document, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". The subject device is considered a surface device that is in contact with the mucosal membrane for > 30 days. The ISO 10993-1 standard was followed, and the following biological safety aspects have been addressed: Cytotoxicity in accordance with ISO 10993-5 Sensitization in accordance with ISO 10993-10 Intracutaneous reactivity in accordance with ISO 10993-10 Irritation(oral) in accordance with ISO 10993-10 Acute systemic toxicity in accordance with ISO 10993-11 Sub-chronic toxicity in accordance with ISO 10993-11 Genotoxicity test in accordance with ISO 10993-3 Implantation in accordance with ISO 10993-6 # X. CLINICAL DATA Clinical performance data was not provided for the TERA HARZ HARD DENTURE. # XI. CONCLUSIONS The test results of the non-clinical tests performed on the subject device supported that the device is substantially equivalent to the predicate devices despite the differences. Based on the information provided in this premarket notification, Graphy Inc. concludes that the TERA HARZ HARD DENTURE is substantially equivalent to the predicate device as described herein. Page 12 / 12