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:

Design:
Scanner: 3Shape A/S, TRIOS 3 Basic
Design software: 3Shape A/S, 3Shape Ortho System™

Printing:
3D Printer: UNIZ, SLASH 2; SprintRay Inc., SprintRay Pro 95

Post-Curing:
Post-cure unit: CureM, U102H

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.

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 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 µm on the x, y axis, and it is possible to produce three-dimensional 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 methacrylatebased 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, regulation 872.3661.

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 industry-standard "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, 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 are provides them to the patient the confirming fit and design.

AI/ML Overview

This document describes the premarket notification for the "TERA HARZ CLEAR" sequential aligner and its substantial equivalence determination by the FDA. The information provided focuses on the device's technical characteristics and performance testing against a predicate device and relevant standards.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance Study

The acceptance criteria are generally based on the ISO 20795-2:2013 standard for "Dentistry - Base Polymers - Part 2: Orthodontic base polymers," and comparisons to a predicate device (Blue Sky Bio Aligner, K180107).

1. Table of Acceptance Criteria and Reported Device Performance

Test Item	Acceptance Criteria	TERA HARZ CLEAR (UNIZ Slash 2) Performance	TERA HARZ CLEAR (SprintRay PRO 95) Performance	Predicate Device (Blue Sky Bio Aligner) Performance
Physical Properties
Surface characteristics	smooth, hard, and glossy	smooth, hard and glossy	smooth, hard and glossy	smooth, hard and glossy
Shape capability	edges are reproduced	edges are reproduced	edges are reproduced	edges are reproduced
Colour	transparently without changing	transparently without changing	transparently without changing	transparently without changing
Freedom from porosity	no porosity	no porosity	no porosity	no porosity
Ultimate Flexural Strength	≥5 MPa	Avg. 5.92 MPa	Avg. 6.02 MPa	Avg. 5.17 MPa
Flexural modulus	≥50 MPa	Avg. 69.10 MPa	Avg. 72.38 MPa	Avg. 56.26 MPa
Solubility	≤5 µg/mm³	Avg. 1.54 µg/mm³	Avg. 1.56 µg/mm³	Avg. 1.67 µg/mm³
Water sorption	≤32 µg/mm³	Avg. 17.45 µg/mm³	Avg. 17.03 µg/mm³	Avg. 17.51 µg/mm³
Precision	standard deviation less than 0.150 mm (implicitly)	Uniz: Avg.0.072/mm (specific values provided)	SprintRay: Avg.0.065/mm (specific values provided)	Avg. 0.122/mm (specific values provided)
Appearance	No foreign materials, contaminations, or defects	No evidence of foreign materials, contaminations,	No evidence of foreign materials, contaminations,	No evidence of foreign materials, contaminations,
		or any other defects	or any other defects	or any other defects
Biocompatibility
Biocompatibility	Biocompatible according to ISO 10993-1	Biocompatible according to ISO 10993-1	Biocompatible according to ISO 10993-1	Predicate did not perform testing (510k clearance)

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: For physical properties testing (such as Ultimate Flexural Strength, Flexural Modulus, Solubility, Water Sorption, Surface characteristics, Shape capability, Colour, Freedom from porosity, and Precision), 5 samples of the "TERA HARZ CLEAR" device were used for each test. These samples were from the same lot and tested using two different 3D printers (UNIZ Slash 2 and SprintRay Pro 95).
Data Provenance: The document does not explicitly state the country of origin for the test data but indicates that the submitting company, Graphy Inc., is located in Seoul, Republic of Korea. The testing itself involved comparisons to a legally marketed predicate device (Blue Sky Bio Aligner) and adherence to international standards (ISO 20795-2:2013). The study appears to be prospective bench testing performed specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts to establish a "ground truth" for the test set in the conventional sense of clinical evaluation. The ground truth for the physical and mechanical properties was established by adherence to the ISO 20795-2:2013 standard and direct comparison against a legally marketed predicate device's performance data.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as the study primarily involved bench testing of physical and mechanical properties against a standard and a predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was conducted or reported in this document. The device is a physical product (sequential aligner), and the evaluation focuses on its material properties and manufacturing validation rather than diagnostic performance or human-in-the-loop effectiveness.

6. Standalone Performance (Algorithm Only)

This section is not applicable as the "TERA HARZ CLEAR" is a physical medical device (sequential aligner), not a software algorithm or AI-powered diagnostic tool. The document describes the design software and 3D printing systems used in its fabrication, but the device itself is the physical aligner.

7. Type of Ground Truth Used

The ground truth for the device's performance was primarily based on:

International Standard Requirements: ISO 20795-2:2013.
Predicate Device Performance: Direct comparison of physical and mechanical properties with a legally marketed predicate device (Blue Sky Bio Aligner, K180107).
Manufacturing Validation: Verifying that manufactured devices meet predefined dimensional tolerances (0.150 mm of the target input value) using independent software and digital calipers.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of an algorithm or AI. Since this is a physical medical device and not an AI/software product, the concept of a training set as typically understood in AI/ML studies is not applicable.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the reasons stated in point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 3, 2022

Graphy Inc. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K223355

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: October 30, 2022 Received: November 2, 2022

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.

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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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K-223355

Device Name TERA HARZ CLEAR

Indications for Use (Describe)

	Brand	Type
Design:
Scanner	3Shape A/S	TRIOS 3 Basic
Design software	3Shape A/S	3Shape Ortho System™
Printing:
3D Printer	UNIZ	SLASH 2
	SprintRay Inc.	SprintRay Pro 95
Post-Curing:
Post-cure unit	CureM	U102H

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)

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K223355

510(k) Summary For TERA HARZ CLEAR

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. Moon Soo Park, Assistant Manager of RA Team

II. SUBMISSION CORRESPONDENT

SMB Korea #606, #607, 7, Boramae-ro 5ga-gil, Donjak-gu, Seoul, 07071, Republic of Korea Cell Phone: +82-10-2247-5579 Office Phone: +62-6241-9001 Kyung-hwan Kim, Representative Consultant, QA Contact: Email: info@smbkorea.com

III. DATE PREPARED

October 20, 2022

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)

DEVICE DESCRIPTION

TERA HARZ CLEAR is a series of clear aligners that are used to replace traditional

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orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth.

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.

However, scanner, design software, 3D printer and post-cure unit are not included with the device.

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, regulation 872.3661.

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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, virtual planning of orthodontic treatments by simulating tooth movements, and design of sequential aligners based on 3D scanned orthodontic models.

VI. 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
	SprintRay Inc.	SprintRay Pro 95
Post-Curing:
Post-cure unit	CureM	U102H

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VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE 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 PREDICATEDevice (K180107)	REFERENCE Device	Significant Difference
Manufacturer	Graphy Inc.	Blue Sky Bio LLC	Formlabs Inc.	-
Trade Name	TERA HARZ CLEAR	Blue Sky Bio Aligner	Dental LT Clear Resin(V2)	-
Device ClassificationName	aligner, sequential	aligner, sequential	MAINTAINER, SPACEPREFORMED,ORTHODONTIC	-
Regulation Number	21 CFR 872.5470	21 CFR 872.5470	21 CFR 872.5525	Predicate device :sameReference device :different
Product Code	NXC	NXC	DYT, KMY	Predicate device :sameReference device :different.
Class	II	II		Predicate device :sameReference device :different.

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	SUBJECT Device	Primary PREDICATE	REFERENCE Device	Significant Difference
		Device (K180107)
Manufacturer	Graphy Inc.	Blue Sky Bio LLC	Formlabs Inc.	–
Indications for Use	TERA HARZ CLEAR isintended for thetreatment of toothmalocclusions in patientswith permanent dentition(i.e., all second molars).Utilizing a series ofincremental toothmovements, itsequentially positionsteeth by way ofcontinuous gentle force.TERA HARZ CLEAR isintended exclusively forprofessional dentalwork. Fabrication ofaligner with TERA HARZCLEAR requires anadditive manufacturingsystem (AMS)thatincludes compatible withthe following:	Blue Sky Bio Alignersare a series of clear,lightweight, plasticappliances indicated forthe treatment of toothmalocclusions inpatients with permanentdentition(i.e., all second molars).Utilizing a series ofincremental toothmovements, itsequentially positionsteeth by way ofcontinuous gentle force.	Dental LT Clear Resin(V2) enables dentalpractices and labs torapidly manufacture arange of dental productsin-house, frombiocompatible surgicalguides and splints tofixed prosthetic andclear aligner models.	Similarities: Indicationsfor use of the subjectdevice is slightlydifferent from thepredicate device inphrase but fundamentalindication is theidentical. However, thereference device isdifferent.
Mechanism of Action	Orthodontic toothmovement occursthrough forces appliedto the teeth by theappliance to thedentition as each toothfollows the programmeddisplacement based ona dental healthprofessional'sprescription.	The mechanism ofaction is similar to thepredicate devices andsupports adetermination ofsubstantial equivalence.Orthodontic toothmovement occursthrough forces appliedto the teeth by theappliance to thedentition as each toothfollows the programmeddisplacement based on adental healthprofessional'sprescription	Unknown	Similarities:Mechanism of action ofthe subject device isidentical from thepredicate device.however, referencedevice is unknown.
	SUBJECT Device	Primary PREDICATEDevice (K180107)	REFERENCE Device	Significant Difference
Manufacturer	Graphy Inc.	Blue Sky Bio LLC	Formlabs Inc.	–
In Use Duration	Aligners are worn for approximately 1 weekof 20-22 hours of wear per day, after which itisreplaced by the next stage aligners. This isrepeated for duration as prescribed by thedental clinician.	Unknown	Unknown	Difference: Because the predicate device andreference device are unknown, we concluded that thepredicate device and the subject device are different.
Materials of Use	Methacrylate-based resins	Essix Thermoplastic resins	Methacrylate-based resins	Difference: The predicate device and subject device isdifferent. However reference device is similar inMethacrylate-based resins.so Dental LT Clear Resin(V2) is selected as a referencedevice to support raw material.
ManufacturingTechnology	Additive	Thermoforming	Additive	Difference: The predicate device and subject device isdifferent. since there are no products in the market thathave the same manufacturing process as our aligners,Dental LT Clear Resin (V2) is selected as a referencedevice to support manufacturing process.
	SUBJECT Device	Primary PREDICATEDevice (K180107)	REFERENCE Device	Significant Difference
Manufacturer	Graphy Inc.	Blue Sky Bio LLC	Formlabs Inc.	–
Design	Image: Subject Device Design	Image: Primary Predicate Device Design	Image: Reference Device Design	Similarities: The archshape does notintroduce anyadditional safety orefficacy concerns.Dimensions of the archform are in the samerange.
Performance Testing	ISO 20795-2:2013	Does not apply.	ISO and ASTM	Similarities: This doesnot introduceadditional safety orefficacy concernsbecause subject deviceand predicate devicemeet somerequirements from ISO20795-2:2013.
Surface characteristics	Testing of 5 samples,same lot with 2 kind of3d printer(UNIZ Slash2 ,SprintRay pro95)The surface of thesample was smooth,hard and glossy;	The surface of thesample was smooth,hard and glossy.	Unknown	Similarities:The specifications ofpredicate device are inthe same range. Thisminor variance does notintroduce additionalsafety or efficacyconcerns because bothdevices meetrequirements from ISO20795-2:2013.
	SUBJECT Device	Primary PREDICATE	REFERENCE Device	Significant Difference
		Device (K180107)
Manufacturer	Graphy Inc.	Blue Sky Bio LLC	Formlabs Inc.	-
Shape capability	Testing of 5 samples,same lot with 2 kinds of3d printer (UNIZ Slash2 ,SprintRay pro95)Sample edgeswerereproduced;	Sample edgeswerereproduced.	Unknown	Similarities:The specifications ofpredicate device are inthe same range. Thisminor variance doesnot introduceadditional safety orefficacy concernsbecause both devicesmeetrequirementsfrom ISO 20795-2:2013.
Colour	Testing of 5 samples,same lot with 2 kind of3d printer (UNIZ Slash2 ,SprintRay pro95)The color wasexpressedtransparentlywithout changing;	The color wasexpressedtransparentlywithout changing.	Unknown	Similarities:The specifications ofpredicate device are inthe same range. Thisminor variance doesnot introduceadditional safety orefficacy concernsbecause both devicesmeetrequirementsfrom ISO 20795-2:2013.

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	SUBJECT Device	Primary PREDICATEDevice (K180107)	REFERENCE Device	Significant Difference
Manufacturer	Graphy Inc.	Blue Sky Bio LLC	Formlabs Inc.	–
Freedom from porosity	Testing of 5 samples,same lot with 2 kind of3d printer (UNIZ Slash2,SprintRay pro95)There is no porosity;	There is no porosity.	Unknown.	Similarities:The specifications ofpredicate device are inthe same range. Thisminor variance doesnot introduceadditional safety orefficacy concernsbecause both devicesmeet requirementsfrom ISO 20795-2:2013.
Ultimate Flexural Strength(≥5 MPa)	Testing of 5 samples,same lot with 2 kind of3d printer (UNIZ Slash2,SprintRay pro95)UnizAvg. 5.91 MPa;SprintRay pro 95Avg. 6.04 MPa	Avg. 5.17 MPa	Unknown	Similarities:The ultimate flexuralstrength of subjectdevice is equivalent toor better than thepredicate devicebecause the averagevalue of the subjectdevice' ultimateflexural strength wasstatistically significantlyhigher than that of thepredicate device.This minor variancedoes not introduceadditionalsafety orefficacy concernsbecause both devicesmeet requirementsfrom ISO 20795-2:2013.

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	SUBJECT Device	Primary PREDICATEDevice (K180107)	REFERENCE Device	Significant Difference
Manufacturer	Graphy Inc.	Blue Sky Bio LLC	Formlabs Inc.	–
Flexural modulus(≥50 MPa)	Testing of 5 samples,same lot with 2 3dprinter (UNIZSlash2,SprintRay pro 95)UnizAvg. 69.10 MPa;SprintRay pro 95Avg. 72.37 MPa	Avg. 56.26 MPa	Unknown	Similarities:The ultimate flexuralstrength of subjectdevice is equivalent toor better than thepredicate because theaverage value of thesubject device'ultimate flexuralstrength wasstatistically significantlyhigher than that ofthe predicate device.This minor variancedoes not introduceadditional safety orefficacy concernsbecause both devicesmeet requirementsfrom ISO 20795-2:2013.

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	SUBJECT Device	Primary PREDICATEDevice (K180107)	REFERENCE Device	Significant Difference
Manufacturer	Graphy Inc.	Blue Sky Bio LLC	Formlabs Inc.	–
Solubility(≤5 µg/mm3)	Testing of 5 samples,same lot with 2 kind of3d printer(UNIZ Slash2 ,SprintRay pro95)UnizAvg. 1.53 µg/mm3;SprintRay pro 95Avg. 1.55 µg/mm3	Avg. 1.67 µg/mm3	Unknown	Similarities:The specifications ofpredicate device are inthe same range.This minor variancedoes not introduceadditional safety orefficacy concernsbecause both devicesmeet requirementsfrom ISO 20795-2:2013.
Water sorption(≤32 µg/mm3)	Testing of 5 samples,same lot with 2 kind of3d printer(UNIZ Slash2 ,SprintRay pro95)UnizAvg. 17.44 µg/mm3;SprintRay pro 95Avg. 17.02 µg/mm3	Avg. 17.51 µg/mm3	Unknown	Similarities:The specifications ofpredicate device are inthe same range.This minor variancedoes not introduceadditional safety orefficacy concernsbecause both devicesmeet requirementsfrom ISO 20795-2:2013.

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	SUBJECT Device	Primary PREDICATEDevice (K180107)	REFERENCE Device(K203000)	Significant Difference
Manufacturer	Graphy Inc.	Blue Sky Bio LLC	Formlabs Inc.	–
Appearance	Testing of 5 samples, same lot with 2 kind of 3d printer(UNIZ Slash2 , SprintRay pro95)No evidence of foreign materials, contaminations,or any other defects that should be hazardous uponthe usage.	No evidence of foreign materials, contaminations, or any other defects that should be hazardous upon the usage.	Unknown	No difference.
Precision(The standard deviationis less than 0.150)	Testing of 5 samples, same lot with 2 kind of 3d printer(UNIZ Slash2 , SprintRay pro95)UnizAvg.0.072/mmSprintRay pro 95Avg.0.065/mm	Avg. 0.122/mm	Unknown	Similarities:The precision of subject device is equivalent to or better than the predicate device because the average value of the subject device' precision was statistically significantly lower than that of the predicate device.
Biocompatibility	Biocompatible according to ISO 10993-1	The material used for the Blue Sky Bio aligners has a 510k clearance as an aligner material ,so no biocompatibility testing was performed.	Biocompatible according to ISO 10993-1	No difference.
OTC or Rx	Rx	Rx	Rx	No difference.
Sterile	Not Applicable	Not Applicable	Not Applicable	No difference.

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VIII. 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 point-to- 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 of the 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.

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TERA HARZ CLEAR

	Representativesample	(Model/type TC-85DAC)3D Printer		Blue Sky BioAligner
	Test Item	UNIZ Slash 2	SprintRayPRO 95	Blue Sky BioAligner	Test criteria
1.	Surfacecharacteristics	Samplesurface issmooth, hardand glossy.	Samplesurface issmooth, hardand glossy.	Samplesurface issmooth, hardand glossy.	surface is smooth,hard, and glossy
2.	Shapecapability	Sample edgesarereproduced.	Sample edgesarereproduced.	Sample edgesarereproduced.	edges arereproduced
3.	Colour	The color isexpressedtransparentlywithoutchanging.	The color isexpressedtransparentlywithoutchanging.	The color isexpressedtransparentlywithoutchanging.	the color isexpressedtransparentlywithout changing
4.	Freedom fromporosity	There is noporosity.	There is noporosity.	There is noporosity.	there is noporosity
5.	UltimateFlexuralStrength(MPa)	Avg. 5.92	Avg. 6.02	Avg. 5.17	≥5 MPa
6.	Flexural modulus(MPa)	Avg. 69.10	Avg. 72.38	Avg. 56.26	≥50 MPa
7.	Solubility	Avg. 1.54	Avg. 1.56	Avg. 1.67	≤5 µg/mm³
8.	Water sorption(≤32 µg/mm³)	Avg. 17.45	Avg. 17.03	Avg. 17.51	≤32 µg/mm³
9.	Precision	1) 0.079/mm2) 0.075/mm3) 0.069/mm4) 0.068/mm5) 0.071/mm	1) 0.063/mm2) 0.069/mm3) 0.065/mm4) 0.071/mm5) 0.059/mm	1) 0.102/mm2) 0.139/mm3) 0.108/mm4) 0.137/mm5) 0.125/mm	less than 0.15

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As a result, TERA HARZ CLEAR tested with two 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 used in dentistry
-EN ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Evaluation and testing
-EN ISO 10993-3:2014, Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
EN ISO 10993-5:2009, Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
-EN ISO 10993-10:2013, Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
-EN ISO 10993-11:2018, Biological evaluation of medical devices – Part 11: Tests for systemic toxicity

IX. CLINICAL DATA

Clinical performance data was not provided for TERA HARZ CLEAR.

X. 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.

Regulation Number and Section

§ 872.5470 Orthodontic plastic bracket.

(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.