TERA HARZ CLEAR

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font. March 5, 2024 Graphy Inc. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059 Re: K240597 Trade/Device Name: Tera Harz Clear Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: March 3, 2024 Received: March 4, 2024 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 (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 -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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K240597 Device Name TERA HARZ CLEAR #### Indications for Use (Describe) TERA HARZ CLEAR is intended for the treatment of tooth malocclusions in patients with permanent dentition (i.e, all second molars). Utilizing a series of increments, it sequentially positions teeth by way of continuous gentle force. TERA HARZ CLEAR is intended exclusively for professional dental work. Fabrication of aligner with TERA HARZ CLEAR requires an additive manufacturing system (AMS) that includes compatible with the following : | | Brand | Type | |-----------------|----------------|----------------------| | Design: | | | | Scanner | 3Shape A/S | TRIOS 3 Basic | | Design software | 3Shape A/S | 3Shape Ortho System™ | | Printing: | | | | 3D Printer | UNIZ | SLASH 2 | | | UNIZ | Nbee | | | SprintRay Inc. | SprintRay Pro 95 | | Post-Curing: | | | | Post-cure unit | CureM | U102H | | | Tera Harz Cure | THC | | 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." {3}------------------------------------------------ ## K240597 510(k) Summary For TERA HARZ CLEAR [Complying with 21 CFR 807.92] #### SUBMISSION SPONSOR l. 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, Assistant Manager of RA Team #### II. SUBMISSION CORRESPONDENT #### III. DATE PREPARED December 05, 2022 (first) February 29 2024 (special) #### IV. DEVICE | Trade or Proprietary Name: | TERA HARZ CLEAR | |----------------------------|----------------------------------------| | Common or Usual Name: | Sequential Aligner | | Classification Name: | Orthodontic plastic bracket (872.5470) | | Regulatory Class: | II | | Product Code: | NXC | | Classification Panel: | Dental | #### v. PREDICATE DEVICE Primary Predicate Device: K180107, Blue Sky Bio Aligner/ Blue Sky Bio LLC (Class II) Referencee Device Dental LT Clear Resin (V2)/ Formlabs Inc. (Class I) #### vi. DEVICE DESCRIPTION TERA HARZ CLEAR is a series of clear aligners that are used to replace traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. TERA HARZ CLEAR have 3 models : TC-85DAC, TR-07, TA-28 This series of aligner is intended for the treatment of tooth malocclusions in patients with permanent dentition (i.e., all second molars) by moves the teeth gently, and in small increments, from their original to their final treated position for {4}------------------------------------------------ improved dental alignment. This series of aligner is worn for approximately 1 week of 20 to 22 hours per day after (However, there are to be removed for eating and for cleaning) which it is replaced by the next stage aligners and are designed to be used in a sequence. This is repeated for duration as prescribed by the dental clinician. TERA HARZ CLEAR is a light-cured, methacrylate-based resin commonly can used in additive manufacturing for the production of dental structures such as sequential aligners. TERA HARZ CLEAR has stored in a black 1,000 g of HDPE bottle. It contains materials with colors of yellowish. This device is a liquid photo-curable material that is polymerized by UV laser at 405~412 nm. It can be used to make a tooth model with a photo-curable polymer that is cured by ultraviolet light. The liquid UV curing resin is cured at a specific wavelength (395~405 nm) by the photo-initiator contained in the resin. It is typically 100 um in thickness and is output at a resolution of 40 to 90 um on the x, y axis, and it is possible to produce threedimensional printed matter by curing lamination step by step a thickness of 100 um. However, scanner, design software, 3D printer and post-cure unit are not included with the device. These fabrications of TERA HARZ CLEAR are beginning with the dental clinician prescribing aligners to treat a patient's malocclusion, and decision to use methacrylate- based resins is made by the dental clinician. TERA HARZ CLEAR, an orthodontic appliance such as sequential aligner, 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 listed with Intraoral scanner under FDA Classification Product Code NOF, regulation872.3661. This digital file is a series of CAD files (.stl) for building models that can be used to fabricate aligners. Commonly used standard dental software is used by dental professionals to virtually design a sequential aligner and generate an industrystandard "STL" 3D dataset which reflects the intended shape and contour. The design software used is 3Shape Ortho System™ by 3Shape A/S (K180941). The specialized orthodontic treatment planning software has a 510k clearance for the intended use under FDA Classification Product Code PNN, regulation 872.5470. This software is used for management of 3D scanned orthodontic models, orthodontic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned orthodontic models, {5}------------------------------------------------ virtual planning of orthodontic treatments by simulating tooth movements, and design of sequential aligners based on 3D scanned orthodontic models. Once dental clinic manufacturing unit receive the data that *.stl CAD files of the treatment plan the 3D printer begins additive manufacturing. The dental clinician generates sequential 3D printed models replicating the approved treatment plan. The sequential aligner is 3D printed and cured in a post-cure unit. The fabricated aligners are cut to fit dentition, the cleaned and polished to remove rough edges by the dental clinician. The prescribing physician review and approves the sequential aligners areprovides them to the patient the confirming fit and design. #### vii. INDICATION FOR USE TERA HARZ CLEAR is intended for the treatment of tooth malocclusions in patients with permanent dentition (i.e., all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous gentle force. TERA HARZ CLEAR is intended exclusively for professional dental work. Fabrication of aligner with TERA HARZ CLEAR requires an additive manufacturing system (AMS) that includes compatible with the following: | | Brand | Type | |--------------------------------|----------------|----------------------| | Design: | | | | Intraoral scanner | 3Shape A/S | TRIOS 3 Basic | | Design software | 3Shape A/S | 3Shape Ortho System™ | | Additive Manufacturing System: | | | | 3D Printer | UNIZ | SLASH 2 | | | UNIZ | Nbee | | | SprintRay Inc. | SprintRay Pro 95 | | Post-Curing: | | | | Post-cure unit | CureM | U102H | | | Tera Harz Cure | THC | {6}------------------------------------------------ #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VIII. PREDICATE DEVICE The indications for use and mechanism of action of subject device is identical to the predicate device and supports a determination of substantial equivalence. However, there is a main difference in the predicate device because the materials of use and the manufacturing process are differed. So, Dental LT Clear Resin (V2) is selected as a reference device to support method of processing and raw material. So that. TERA HARZ CLEAR performed testing as that of each predicate device. All test results of Flexural Strength, Flexural Modulus, Water Solubility, and Water Sorption was similar to that of the predicate device that meet the requirements of ISO 20795-2:2013. The performance characteristics of the TERA HARZ CLEAR are comparable to those of the predicate device for this particular indication and raise no new or different questions of safety and effectiveness. Therefore, the subject device and the predicate device are substantially equivalent in physical properties. Any differences in technology characteristics are accompanied by information that demonstrated the device is as safe and as effective as the predicate device and do not raise different questions of safety and effectiveness than the predicate. It was concluded, therefore, that the technological differences do not raise different questions of safety and effectiveness. | | SUBJECT Device | Primary PREDICATE<br>Device (K180107) | REFERENCE Device | Significant<br>Difference | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Graphy Inc. | Blue Sky Bio LLC | Formlabs Inc. | - | | Trade Name | TERA HARZ CLEAR | Blue Sky Bio Aligner | Dental LT Clear Resin<br>(V2) | - | | Device Classification<br>Name | aligner,<br>sequential | aligner,<br>sequential | MAINTAINER, SPACE<br>PREFORMED,<br>ORTHODONTIC | - | | Regulation Number | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR 872.5525 | Predicate device :<br>same<br>Reference device :<br>different | | Product Code | NXC | NXC | DYT, KMY | Predicate device :<br>same<br>Reference device :<br>different. | | Class | II | II | I | Predicate device :<br>same<br>Reference device : | | | SUBJECT Device | Primary PREDICATE<br>Device (K180107) | REFERENCE Device | Significant Difference | | Manufacturer | Graphy Inc. | Blue Sky Bio LLC | Formlabs Inc. | | | Indications for Use | TERA HARZ CLEAR<br>is intended for the<br>treatment of tooth<br>malocclusions in<br>patients with permanent<br>dentition<br>(i.e., all second molars).<br>Utilizing a series<br>of<br>incremental tooth<br>movements, it<br>sequentially positions<br>teeth by way of<br>continuous gentle<br>force.<br>TERA HARZ CLEAR<br>is intended exclusively<br>for professional dental<br>work. Fabrication of<br>aligner with TERA<br>HARZ CLEAR<br>requires an<br>additive manufacturing<br>system (AMS) that<br>includes compatible<br>with the following: | Blue Sky Bio<br>Aligners<br>are a series of clear,<br>lightweight, plastic<br>appliances indicated<br>for the treatment of<br>tooth malocclusions in<br>patients with<br>permanent dentition<br>(i.e., all second<br>molars).<br>Utilizing a series of<br>incremental tooth<br>movements, it<br>sequentially positions<br>teeth by way of<br>continuous gentle<br>force. | Dental LT Clear Resin<br>(V2) enables dental<br>practices and labs to<br>rapidly manufacture a<br>range of dental<br>products in-house,<br>from biocompatible<br>surgical guides and<br>splints to fixed<br>prosthetic and clear<br>aligner models. | Similarities:<br>Indications<br>for use of the subject<br>device is slightly<br>different from the<br>predicate device in<br>phrase but<br>fundamental indication<br>is the identical.<br>However, the<br>reference device is<br>different. | | Mechanism of Action | Orthodontic tooth<br>movement occurs<br>through forces<br>applied<br>to the teeth by the<br>appliance to the<br>dentition as each tooth<br>follows the<br>programmed<br>displacement based<br>on<br>a dental health<br>professional's<br>prescription. | The mechanism of<br>action is similar to<br>the<br>predicate devices and<br>supports a<br>determination of<br>substantial<br>equivalence.<br>Orthodontic tooth<br>movement occurs<br>through forces<br>applied<br>to the teeth by the<br>appliance to the<br>dentition as each tooth<br>follows the<br>programmed<br>displacement based<br>on a dental health<br>professional's<br>prescription | Unknown | Similarities:<br>Mechanism of action<br>of<br>the subject device is<br>identical from the<br>predicate device.<br>However, reference<br>device is unknown. | | | SUBJECT Device | Primary PREDICATE<br>Device (K180107) | REFERENCE Device | Significant<br>Difference | | Manufacturer | Graphy Inc. | Blue Sky Bio LLC | Formlabs Inc. | – | | In Use Duration | Aligners are worn for approximately 1 week of 20-22 hours of wear per day, after which it is replaced by the next stage aligners. This is repeated for duration as prescribed by the dental clinician. | Unknown | Unknown | Difference: Because the predicate device and reference device are unknown, we concluded that the predicate device and the subject device are different. | | Materials of Use | Methacrylate-based resins | Essix Thermoplastic | Methacrylate-based resins | Difference: The predicate device and subject device is different. However reference device is similar in Methacrylate-based resins. so Dental LT Clear Resin(V2) is selected as a reference device to support raw material. | | Manufacturing<br>Technology | Additive | Thermoforming | Additive | Difference: The predicate device and subject device is different. Since there are no products in the market that have the same manufacturing process as our aligners, Dental LT Clear Resin (V2) is selected as a reference device to support manufacturing process. | | | SUBJECT Device | Primary PREDICATE<br>Device (K180107) | REFERENCE Device | Significant<br>Difference | | Manufacturer | Graphy Inc. | Blue Sky Bio LLC | Formlabs Inc. | - | | Design | Image: clear aligners | Image: clear aligner | Image: clear aligner | Similarities: The arch<br>shape does not<br>introduce any<br>additional safety or<br>efficacy concerns.<br>Dimensions of the<br>arch form are in the<br>same<br>range. | | Model | -TC-85DAC<br>-TA-28<br>-TR-07 | Unknown | Unknown | - | | Performance Testing | ISO 20795-2:2013 | Does not apply. | ISO and ASTM | Similarities: This<br>does not introduce<br>additional safety or<br>efficacy concerns<br>because subject<br>device and predicate<br>device meet some<br>requirements from<br>ISO 20795-2:2013. | | Surface characteristics | The surface of the<br>sample was smooth,<br>hard and glossy; | The surface of the<br>sample was smooth,<br>hard and glossy. | Unknown | Similarities:<br>The specifications of<br>predicate device are in<br>the same range. This<br>minor variance does<br>not introduce<br>additional safety or<br>efficacy concerns<br>because both devices<br>meet requirements<br>from ISO 20795-<br>2:2013. | | | SUBJECT Device | Primary PREDICATE<br>Device (K180107) | REFERENCE Device | Significant<br>Difference | | Manufacturer | Graphy Inc. | Blue Sky Bio LLC | Formlabs Inc. | – | | Shape capability | Sample edges<br>were<br>reproduced; | Sample<br>edges were<br>reproduced. | Unknown | Similarities:<br>The specifications of<br>predicate device are<br>in the same range.<br>This minor variance<br>does not introduce<br>additional safety or<br>efficacy concerns<br>because both<br>devices meet<br>requirements from<br>ISO 20795-2:2013. | | Colour | Test sample was<br>expressed<br>transparently without<br>changing; | The color was<br>expressed<br>transparently<br>without changing. | Unknown | Similarities:<br>The specifications of<br>predicate device are<br>in the same range.<br>This minor variance<br>does not introduce<br>additional safety or<br>efficacy concerns<br>because both<br>devices meet<br>requirements from<br>ISO 20795-2:2013. | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ | | SUBJECT Device | Primary PREDICATE<br>Device (K180107) | REFERENCE Device | Significant<br>Difference | |--------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Graphy Inc. | Blue Sky Bio LLC | Formlabs Inc. | – | | Freedom from porosity | There is no porosity | There is no porosity. | Unknown. | Similarities:<br>The specifications of predicate device are in the same range. This minor variance does not introduce additional safety or efficacy concerns because both devices meet requirements from ISO 20795-2:2013. | | Ultimate Flexural<br>Strength<br>(≥50 MPa) | TC-85DAC<br>Avg. 58.04 MPa;<br>TA-28<br>Avg. 70.26MPa<br>TR-07<br>Avg. 75.74MPa | Avg. 51.7 MPa | Unknown | Similarities:<br>The ultimate flexural strength of subject device is equivalent to or better than the predicate device because the average value of the subject device' ultimate flexural strength was statistically significantly higher than that of the predicate device. This minor variance does not introduce additional safety or efficacy concerns because both devices meet requirements from ISO 20795-2:2013. | {12}------------------------------------------------ | | SUBJECT Device | Primary PREDICATE<br>Device (K180107) | REFERENCE Device | Significant<br>Difference | |---------------------------------|-----------------------------------------------------------------------------|---------------------------------------|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Graphy Inc. | Blue Sky Bio LLC | Formlabs Inc. | - | | Flexural modulus<br>(≥1500 MPa) | TC-85DAC<br>Avg 1575 MPa;<br>TA-28<br>Avg. 1849MPa<br>TR-07<br>Avg. 1764MPa | Avg. 1560 MPa | Unknown | Similarities:<br>The ultimate flexural<br>strength of subject<br>device is equivalent<br>to or better than the<br>predicate because<br>the average value<br>of the subject<br>device' ultimate<br>flexural strength was<br>statistically<br>significantly<br>higher than that of<br>the predicate device.<br>This minor variance<br>does not introduce<br>additional safety or<br>efficacy concerns<br>because both devices<br>meet requirements<br>from ISO 20795-<br>2:2013. | {13}------------------------------------------------ | | SUBJECT Device | Primary PREDICATE<br>Device (K180107) | REFERENCE Device | Significant<br>Difference | |--------------------------------|-----------------------------------------------------------------------------------------|---------------------------------------|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Graphy Inc. | Blue Sky Bio LLC | Formlabs Inc. | - | | Solubility<br>(≤5 µg/mm³) | TC-85DAC<br>Avg 1.56 µg/mm³<br>TA-28<br>Avg. 1.30 µg/mm³<br>TR-07<br>Avg. 1.39 µg/mm³ | Avg. 1.67 µg/mm³ | Unknown | Similarities:<br>The specifications of<br>predicate device are<br>in the same range.<br>This minor variance<br>does not introduce<br>additional safety or<br>efficacy concerns<br>because both devices<br>meet requirements<br>from ISO 20795-<br>2:2013. | | Water sorption<br>(≤32 µg/mm³) | TC-85DAC<br>Avg 17.03 µg/mm³<br>TA-28<br>Avg. 16.41µg/mm³<br>TR-07<br>Avg. 16.22 µg/mm³ | Avg. 17.51 µg/mm³ | Unknown | Similarities:<br>The specifications of<br>predicate device are<br>in the same range.<br>This minor variance<br>does not introduce<br>additional safety or<br>efficacy concerns<br>because both devices<br>meet requirements<br>from ISO 20795-<br>2:2013. | {14}------------------------------------------------ | | SUBJECT Device | Primary PREDICATE<br>Device (K180107) | REFERENCE Device<br>(K203000) | Significant<br>Difference | |---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Graphy Inc. | Blue Sky Bio LLC | Formlabs Inc. | – | | Appearance | No evidence of<br>foreign materials,<br>contaminations, or<br>any other defects that<br>should be hazardous<br>upon the usage. | No evidence of<br>foreign materials,<br>contaminations, or<br>any other defects that<br>should be hazardous<br>upon the usage. | Unknown | No difference. | | Precision<br>(The standard<br>deviationis less than<br>0.150) | TC-85DAC<br>Avg.0.086/mm<br>TA-28<br>Avg.0.079/mm<br>TR-07<br>Avg.0.084/mm | Avg. 0.122/mm | Unknown | Similarities:<br>The precision of<br>subject device is<br>equivalent to or<br>better than the<br>predicate device<br>because the average<br>value of the subject<br>device' precision was<br>statistically<br>significantlylower<br>than that of the<br>predicate device. | | Biocompatibility | Biocompatible<br>according to<br>ISO10993-1 | The material used<br>forthe Blue Sky Bio<br>aligners has a 510k<br>clearance as an<br>aligner material ,so no<br>biocompatibility testing<br>was performed. | Biocompatible<br>according to ISO<br>10993-1 | No difference. | | OTC or Rx | Rx | Rx | Rx | No difference. | | Sterile | Not Applicable | Not Applicable | Not Applicable | No difference. | | Shelf-life | 2 year | 2 year | unknown | same | {15}------------------------------------------------ #### IX. 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 CLEAR. An independent 3rd party software and digital calipers were used to perform pointto- point 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 CLEAR 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 30°, 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. #### Performance Testing Bench testing was performed to ensure the accuracy of the final product carried through the entire process from the initial intraoral scan through treatment planning and manufacturing process ofthe final finished aligner. In addition, bench testing was conducted on both the subject device and the predicate device (Blue Sky Bio Aligner, K180107) to evaluate critical properties including Flexural Strength, Flexural Modulus, Water Solubility, Water absorption and etc. All met the requirements of ISO 20795-2:2013, Dentistry - Base Polymers - Part 2: Orthodontic base polymers. {16}------------------------------------------------ As a result, TERA HARZ CLEAR tested with three types of 3D prints and predicate device met the tests criteria according to ISO 20795-2:2013, Dentistry -Base Polymers - Part 2: Orthodontic base polymers. The result of the performance comparison test demonstrates that TERA HARZ CLEAR is substantially equivalent to the predicate device in physical properties. Both devices meet requirements of ISO 20795-2:2013. ## Biocompatibility A biocompatibility discussion was conducted. The TERA HARZ CLEAR uses the methacrylate-based resin, and this material has been tested and shown to be compliant with the following standards: - -EN ISO 7405:2018, Dentistry - Evaluation of biocompatibility of medical devices usedin dentistry - -EN ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluationand testing - -EN ISO 10993-3:2014, Biological evaluation of medical devices - Part 3: Tests forgenotoxicity, carcinogenicity and reproductive toxicity - EN ISO 10993-5:2009, Biological evaluation of medical devices Part 5: -Tests for invitro cytotoxicity - EN ISO 10993-10:2013, Biological evaluation of medical devices Part 10: -Tests forirritation and skin sensitization - -EN ISO 10993-11:2018, Biological evaluation of medical devices - Part 11: Tests forsystemic toxicity ## X. CLINICAL DATA Clinical performance data was not provided for TERA HARZ CLEAR. ## xi. CONCLUSIONS The TERA HARZ CLEAR is very similar to the predicate device and demonstrate substantial equivalence to predicate device K180107 in physical properties. An analysis for subject device compared to the predicate device show TERA HARZ CLEAR and the Blue Sky Bio Aligner meet the requirements of Manufacturing Validation, 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 CLEAR and the Blue Sky Bio Aligner meet the requirements of ISO 20795-2:2013, Dentistry – Base Polymers – Part 2: Orthodontic base polymers. All two devices meet or exceed the minimum strength requirements, and all two are biocompatible. Any differences between subject device and the predicate device are material of use and method of processing. So reference device, which has same method of processing and is similar in material of use, is added to support material of use and method of processing.