(1 days)
TERA HARZ II is intended as an indirect restorative for both anterior restorations, including occlusal surfaces.
The TERA HARZ II 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 II requires a computer-aided and manufacturing (CAD/CAM) system that includes the following : scanner, design software, additive printer, and post-cure unit.
The TERA HARZ II is a light-cured, methacylate oligomer based polymerizable resin used by dentist or dental technician for the CAD/CAM manufacturing of indirect restorative for both anterior and posterior restorations, including dcclusal surfaces, such as temporary or permanent crowns and bridges, inlays, onlays, and veneers. Methacrylate based resin is well known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical and biocompatible properties.
The TERA HARZ II is made by Methacrylate-based resins. It has stored in a black 1,000g of HDPE bottle. It contains materials with shade A1/A2/A3/B1/B2/B3/C1/C2/C3/D1/D2/D3/OM1/OM2/OM3/M4. This resin is a liquid photopolymer material that is polymerized by UV laser at 405412nm. the resin can be used to create a customized artificial permanent tooth model with a 3d printer that is cured by ultraviolet light. The liquid UV curing resin is cured at a specific wavelength (395405nm) by the photo-initiator contained in the resin. Curing in a 3D printer is related to the conditions of the printer equipment, and is typically 100um in layer thickness, and is output at a resolution of 40 to 90μm on the x, y axis. This device should use specific 3D Printer equipment using UV light source, and it is possible to produce three-dimensional printed matter by curing lamination step by step a thickness of 100μm.
However, scanner, design software, 3D printer and post-cure unit are not included with the device.
TERA HARZ II can be used in combination with all lasers and DLP based 3D printers which support dental materials. TERA HARZ II is a resin for the generative production of longterm temporary dental restorations based on image projection systems (405-412 nm). The formulation of TERA HARZ II is optimized for the requirements of a robust production guaranteeing constant high quality. The TERA HARZ II is successfully tested for biocompatibility, certainly meets all mechanical and application demands. The material is used in a 3D printer, which prints the shape determined by a 3D stereo-lithographic drawing.
The material can be used for build processes with layer thicknesses from 25 up to 100 um. After printing, the printed product is recommended to use a UV-light curing for final polymerization.
These fabrications of TERA HARZ II are beginning with the dental clinician prescribing indirect restorative to treat a patient's both anterior restorations, including occlusal surfaces, and decision to use methacrylate-based resins is made by the dental clinician. TERA HARZ II, a permanent or temporary restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations, is manufactured in a 3D printer that is compatible.
The dental clinician can generate a digital file by scanning the patient's mouth directly using approved Intraoral scanner software. This digital file is a series of CAD files (.stl) for building models that can be used to fabricate permanent or temporary restorations. Commonly used standard dental software is used by dental professionals to virtually design a restoration and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The design software used is 3D Scanner by 3Shape A/S (510(K) Exempt). The specialized prosthetic treatment planning software has a establishment registration for the intended use under FDA Classification Product Code NOF, regulation 872.3661. This software is used for management of 3D scanned prosthetic models, prosthetic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned prosthetic models, virtual planning of prosthetic treatments by simulating tooth movements, and design of permanent or temporary restorations based on 3D scanned prosthetic models.
Once dental clinic manufacturing unit receive the data that * .stl CAD files of crown and bridge the 3D printer begins additive manufacturing. The dental clinician (e.g., dentist) generates sequential 3D printed models replicating the approved treatment plan. The permanent or temporary restorations is 3D printed and cured in a post-curing unit. The fabricated permanent or temporary restorations are cut to fit dentition, the cleaned and polished to remove rough edges by the dental clinician. The prescribing physician review and approves the permanent or temporary restorations are provides them to the patient the confirming fit and design.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for TERA HARZ II:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a dental material, and its performance is evaluated against the international standard ISO 10477:2020: Dentistry - Polymer-based crown and veneering materials. The key performance characteristics and their acceptance criteria (as per ISO 10477:2020) and reported performance are:
| Acceptance Criteria (ISO 10477:2020) | Reported Device Performance (TERA HARZ II) |
|---|---|
| Depth of Cure: Bottom surface shall be not less than 70% of the hardness of top surface | Avg. 91.3% |
| Flexural Strength: ≥ 50 MPa | Avg. 125.5 MPa |
| Water Sorption: ≤ 40 µg/mm³ | Avg. 22.03 µg/mm³ |
| Solubility: ≤ 7.5 µg/mm³ | Avg. 0.12 µg/mm³ |
| Shade consistency: No difference in color from different batches observed | No difference observed |
| Color stability: No color change after aging treatments detected | No color change detected |
| Biocompatibility: In accordance with ISO 10993-1, ISO 7405, ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11 | Meets all specified ISO standards |
| Manufacturing Validation: All translational measurements within 0.150 mm of target input value | All translational measurements within 0.150 mm of target input value |
| Manufacturing Validation (Flexural Strength for Optimal Output Condition): ≥ 50 MPa | All specimens ≥ 50 MPa for optimal output condition |
| Manufacturing Validation (Material Reuse): No problem in effective outputs for repeated material output up to 6 times | Confirmed no problem for repeated material output up to 6 times |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes for each specific test (e.g., number of specimens for flexural strength, water sorption tests). However, it implies multiple specimens were tested for each characteristic. The data provenance is not explicitly mentioned as retrospective or prospective or specific country of origin, but it is implied to be laboratory-based bench testing conducted by the manufacturer or a third-party for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the type of device and testing described. The "ground truth" for this device's performance is established by adherence to recognized international standards (ISO 10477:2020 and ISO 10993 series). The standards themselves are developed by expert committees, but there isn't a "test set" requiring individual expert adjudication for ground truth in this context.
4. Adjudication Method for the Test Set
Not applicable. The performance is measured against objective, quantitative criteria defined by international standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or AI-assisted interpretation, where human readers interact with the device's output. TERA HARZ II is a dental restorative material, and its effectiveness is determined by its physical and chemical properties and biocompatibility, not by human interpretation of its output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is also not applicable in the typical sense. TERA HARZ II is a material, not a standalone algorithm. Its performance is measured directly through bench testing of the material itself. The manufacturing process does involve CAD/CAM systems and 3D printers, which are "standalone" in their function, but the performance evaluation focuses on the resulting material.
7. The Type of Ground Truth Used
The ground truth used for assessing the device's performance is established international consensus standards for dental materials, specifically ISO 10477:2020 and a battery of ISO 10993 standards for biocompatibility. These standards define the acceptable range for various physical, mechanical, and biological properties.
8. The Sample Size for the Training Set
Not applicable. TERA HARZ II is a material, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is involved for this device.
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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 1, 2023
Graphy Inc. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K233502
Trade/Device Name: Tera Harz II Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: Class II Product Code: EBF, EBG Dated: October 30, 2023 Received: October 31, 2023
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 -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
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Indications for Use
510(k) Number (if known)
Device Name TERA HARZ II
Indications for Use (Describe)
TERA HARZ II is intended as an indirect restorative for both anterior restorations, including occlusal surfaces.
The TERA HARZ II 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 II requires a computer-aided and manufacturing (CAD/CAM) system that includes the following : scanner, design software, additive printer, and post-cure unit.
| Brand | Type | |
|---|---|---|
| Design : | 3 Shape A/S | TRIOS 3 Basic |
| Instraoral scanner | 3 Shape A/S | 3Shape dental system |
| Design software | ||
| Additive Manufacturing system : | ||
| 3D Printer | UNIZ | NBEE |
| SprintRay Inc. | 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) |
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510(k) Summary
For
TERA HARZ II
[Complying with 21 CFR 807.92]
l. SUBMISSION SPONSOR
Graphy Inc. #603, #617, Ace Gasan Forhu, 225, Gasan digital 1-ro, Geumcheon-gu, Seoul, Republic of Korea Office Phone: +82-2-864-3056 Fax: 82-2-864-3057 Contact Person: Mr. Moon-Soo Park, Assistant Manager of RA Team
II. SUBMISSION CORRESPONDENT
III. DATE PREPARED
04 October 2023
IV. DEVICE
| Trade or Proprietary Name: | TERA HARZ II |
|---|---|
| Common or Usual Name: | Preformed Crown and Bridge |
| Classification Name: | Tooth shade resin material (21 CFR 872.3690)Crown and Bridge, Temporary, Resin (21 CFR 872.3770) |
| Regulatory Class: | II |
| Product Code: | EBF, EBG |
| Classification Panel: | Dental |
V. PREDICATE DEVICE
Primary Predicate Device: K202846, TERA HARZ / Graphy Inc. (Class II) Referencee Device K222414, TERA HARZ DENTURE / Graphy Inc. (Class II)
VI. DEVICE DESCRIPTION
The TERA HARZ II is a light-cured, methacylate oligomer based polymerizable resin used by dentist or dental technician for the CAD/CAM manufacturing of indirect restorative for both anterior and posterior restorations, including dcclusal surfaces, such as temporary or permanent crowns and bridges, inlays, onlays, and veneers. Methacrylate based resin is well known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical and biocompatible properties.
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Image /page/4/Picture/0 description: The image contains the word "Graphy" in orange font. The font is sans-serif and appears to be bolded. The word is displayed horizontally and is the only element in the image.
The TERA HARZ II is made by Methacrylate-based resins. It has stored in a black 1,000g of HDPE bottle. It contains materials with shade
A1/A2/A3/B1/B2/B3/C1/C2/C3/D1/D2/D3/OM1/OM2/OM3/M4. This resin is a liquid photopolymer material that is polymerized by UV laser at 405412nm. the resin can be used to create a customized artificial permanent tooth model with a 3d printer that is cured by ultraviolet light. The liquid UV curing resin is cured at a specific wavelength (395405nm) by the photo-initiator contained in the resin. Curing in a 3D printer is related to the conditions of the printer equipment, and is typically 100um in layer thickness, and is output at a resolution of 40 to 90μm on the x, y axis. This device should use specific 3D Printer equipment using UV light source, and it is possible to produce three-dimensional printed matter by curing lamination step by step a thickness of 100μm.
However, scanner, design software, 3D printer and post-cure unit are not included with the device.
TERA HARZ II can be used in combination with all lasers and DLP based 3D printers which support dental materials. TERA HARZ II is a resin for the generative production of longterm temporary dental restorations based on image projection systems (405-412 nm). The formulation of TERA HARZ II is optimized for the requirements of a robust production guaranteeing constant high quality. The TERA HARZ II is successfully tested for biocompatibility, certainly meets all mechanical and application demands. The material is used in a 3D printer, which prints the shape determined by a 3D stereo-lithographic drawing.
The material can be used for build processes with layer thicknesses from 25 up to 100 um. After printing, the printed product is recommended to use a UV-light curing for final polymerization.
These fabrications of TERA HARZ II are beginning with the dental clinician prescribing indirect restorative to treat a patient's both anterior restorations, including occlusal surfaces, and decision to use methacrylate-based resins is made by the dental clinician. TERA HARZ II, a permanent or temporary restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations, is manufactured in a 3D printer that is compatible.
The dental clinician can generate a digital file by scanning the patient's mouth directly using approved Intraoral scanner software. This digital file is a series of CAD files (.stl) for building models that can be used to fabricate permanent or temporary restorations. Commonly used standard dental software is used by dental professionals to virtually design a restoration and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The design software used is 3D Scanner by 3Shape A/S (510(K) Exempt). The specialized prosthetic treatment planning software has a establishment registration for the intended use under FDA Classification Product Code
{5}------------------------------------------------
NOF, regulation 872.3661. This software is used for management of 3D scanned prosthetic models, prosthetic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned prosthetic models, virtual planning of prosthetic treatments by simulating tooth movements, and design of permanent or temporary restorations based on 3D scanned prosthetic models.
Once dental clinic manufacturing unit receive the data that * .stl CAD files of crown and bridge the 3D printer begins additive manufacturing. The dental clinician (e.g., dentist) generates sequential 3D printed models replicating the approved treatment plan. The permanent or temporary restorations is 3D printed and cured in a post-curing unit. The fabricated permanent or temporary restorations are cut to fit dentition, the cleaned and polished to remove rough edges by the dental clinician. The prescribing physician review and approves the permanent or temporary restorations are provides them to the patient the confirming fit and design.
VII. INDICATION FOR USE
TERA HARZII is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces.
The TERA HARZ II material is used for fabricating permanent or temporary restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ II requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and postcure unit.
| Brand | Type | |
|---|---|---|
| Design: | ||
| Intraoral scanner | 3Shape A/S | TRIOS 3 Basic |
| Design software | 3Shape A/S | 3Shape Dental System |
| Additive Manufacturing System: | ||
| 3D Printer | UNIZ | Nbee |
| SprintRay Inc. | SprintRay Pro 95 | |
| Post-Curing: | ||
| Post-cure unit | CureMTERA HARZ CURE | U102HTHC2 |
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VIII. 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 two main differences in the predicate device because the material of use and the physical property values are differed. The subject device has more flexible physical properties compared to the predicate device.
So, TERA HARZ DENTURE is selected as a reference device to support difference of raw material. The reference device has exactly the same raw material composition as the subject device. In addition, although there is a difference in physical property values, both products satisfy the acceptance criteria of ISO 10477:2020.
The following table compares the TERA HARZ II to the predicate device with respect to indications for use, principles of operation, technological characteristics, method of manufacturing.
The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device. 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
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| SUBJECT Device | Primary PREDICATEDevice (K202846) | Significant Difference | |
|---|---|---|---|
| Manufacturer | Graphy Inc. | Graphy Inc. | - |
| Trade Name | TERA HARZ II | TERA HARZ |
| Regulation Description | -Tooth shade resin materials- Crown and Bridge,Temporary, Resin | -Tooth shade resin materials- Crown and Bridge,Temporary, Resin | Same |
|---|---|---|---|
| Regulation Number | -21 CFR 872.3690-21 CFR 872.3770 | -21 CFR 872.3690-21 CFR 872.3770 | Same e |
| Product Code | EBFEBG | EBFEBG | Same |
| Class | II | II | Same |
| Indication for Use | TERA HARZ II is indicatedas an indirectrestorative for bothanterior and posteriorrestorations, includingocclusal surfaces.The TERA HARZmaterial is used forfabricating temporaryor permanentrestorations such ascrowns and bridges,inlays, onlays, veneersand full crownrestorations.Fabrication of TERAHARZ requires acomputer-aided andmanufacturing(CAD/CAM) systemthat includes thefollowing: scanner,design software,additive printer, andpost-cure unit. | TERA HARZ is indicatedas an indirectrestorative for bothanterior and posteriorrestorations, includingocclusal surfaces.The TERA HARZmaterial is used forfabricating temporaryor permanentrestorations such ascrowns and bridges,inlays, onlays, veneersand full crownrestorations.Fabrication of TERAHARZ requires acomputer-aided andmanufacturing(CAD/CAM) systemthat includes thefollowing: scanner,design software,additive printer, andpost-cure unit. | Similar: The indication foruse of the subject device isvery similar to the predicatedevice. |
| Mechanism of Action | The product is aphotopolymer liquid resinthat is manufactured toproducean output within UV lighting3D printer. The material is forproducingpolymeric dental prosthesisaccording to ISO 10477, type2 and class 2. Usinga DLP or SLA 3D printer thatuses photopolymer materials,it is produced 3Doutput layer by layer. Byreading a STL file whichcontains 3D information ofthe dental prosthesis of apatient's oral cavity, the 3Dprinter can create a | The product is aphotopolymer liquid resinthat is manufactured toproducean output within UV lighting3D printer. The material is forproducingpolymeric dental prosthesisaccording to ISO 10477, type2 and class 2. Usinga DLP or SLA 3D printer thatuses photopolymer materials,it is produced 3Doutput layer by layer. Byreading a STL file whichcontains 3D information ofthe dental prosthesis of apatient's oral cavity, the 3Dprinter can create a | Same |
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| SUBJECT Device | Primary PREDICATEDevice (K202846) | Significant Difference | |
|---|---|---|---|
| Manufacturer | Graphy Inc. | Graphy Inc. | - |
| Trade Name | TERA HARZ II | TERA HARZ |
| continuous layer. When the3D printer emits light tothe resin with specific patternof a shape, the photoinitiatorin the resinabsorbs the pattern of UVwavelength band. It causes aphotocuring reactionin a pattern shape and thephotopolymer resin iscuredlayer by layer and it iscontinuously carried out toproduce the shape that youwant. The operation | continuous layer. When the3D printer emits light tothe resin with specific patternof a shape, the photoinitiatorin the resinabsorbs the pattern of UVwavelength band. It causes aphotocuring reactionin a pattern shape and thephotopolymer resin iscuredlayer by layer and it iscontinuously carried out toproduce the shape that youwant. The operation | ||
|---|---|---|---|
| is carried out continuously | is carried out continuously | ||
| and finally the output areproduced. | and finally the output areproduced. | ||
| Manufacturing Technology | Additive | Additive | Same |
| Material of Use | Methacrylate-based resinswith photo-initiator, inhibitor andpigments | Methacrylate polymerresin (dimethacrylate) | Different : the subject devicediffers from the predicatedevice in the material of use.The two products are similarmethacrylate-based resins,but they differ slightly in rawmaterial composition. |
| Product state | Pre-mixed resin(liquid) | Pre-mixed resin(liquid) | Same |
| Biocompatibility | Biocompatibleaccording to ISO10993-1 | Biocompatibleaccording to ISO10993-1 | Same |
| Performance Testing | ISO 10477:2020 | ISO 10477:2020 | Same : the subject deviceand predicate device havesame performance testingstandard |
| Depth of Cure (%)(Bottom surface shall be notless than 70% of thehardness of top surface) | Avg. 91.3 | Avg. 93.5 | Similar : the specificationsare in the same range. Thisminor variance does notintroduce additional safety oefficacy concerns. |
| Flexural Strength(≥50 MPa; ISO 10477) | Avg. 125.5 | Avg. 148.73 | Similar : the specificationsare in the same range. Thisminor variance does notintroduce additional safety oefficacy concerns. |
| Water sorption(≤40µg/mm3) | Avg. 22.03 | Avg. 13.03 | Similar : the specificationsare in the same range. Thisminor variance does notintroduce additional safety oefficacy concerns. |
| Solubility(≤7.5 µg/mm3) | Avg. 0.12 | Avg. 1.00 | Similar : the specificationsare in the same range. Thisminor variance does notintroduce additional safety oefficacy concerns. |
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| SUBJECT Device | Primary PREDICATEDevice (K202846) | Significant Difference | |
|---|---|---|---|
| Manufacturer | Graphy Inc. | Graphy Inc. | - |
| Trade Name | TERA HARZ II | TERA HARZ |
| efficacy concerns. | |||
|---|---|---|---|
| Shade consistency | The difference in color from different bataches was not observed. | The difference in color from different bataches was not observed. | same |
| Color stability | Any color change after aging treatments was not detected. | Any color change after aging treatments was not detected. | same |
| OTX or Rx | Rx | Rx | Same |
| Sterile | non-sterile | non-sterile | Same |
| Shelf-life | 2 year | 2 year | Same |
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| SUBJECT Device | REFERENCE Device(K222414) | Significant Difference | |
|---|---|---|---|
| Manufacturer | Graphy Inc. | Graphy Inc. | - |
| Trade Name | TERA HARZ II | TERA HARZ DENTURE |
| Regulation Description | -Tooth shade resin materials- Crown and Bridge,Temporary, Resin | -resin, denture, relining,repairing, rebasing | Different |
|---|---|---|---|
| Regulation Number | -21 CFR 872.3690-21 CFR 872.3770 | -21 CFR 872.3760 | Different |
| Product Code | EBFEBG | EBI | Different |
| Class | II | II | Same |
| Indication for Use | TERA HARZ II is indicated as an indirectrestorative for both anterior and posteriorrestorations, including occlusal surfaces.The TERA HARZ material is used forfabricating temporary or permanentrestorations such as crowns and bridges,inlays, onlays, veneers and full crownrestorations.Fabrication of TERA HARZ requires acomputer-aided and manufacturing(CAD/CAM) system that includes thefollowing: scanner, design software,additive printer, and post-cure unit. | The TERA HARZ DENTURE is alight-curable resin indicated for fabrication andrepair of full and partial removabledentures and baseplates. The material isan alternative to traditional heat-curableand auto polymerizing resins. Fabricationof dental prosthetics with the TERA HARZDENTURE requires a computer-aideddesign and manufacturing (CAD/CAM)system that includes the followingcomponents: digital denture base filesbased on digital impression,stereolithographic additive printer, andcuring light equipment. | Different: The indication foruse of the subject device isdifferent from the referencedevice. |
| Mechanism of Action | The product is aphotopolymer liquid resinthat is manufactured toproducean output within UV lighting3D printer. The material is forproducingpolymeric dental prosthesisaccording to ISO 10477, type2 and class 2. Usinga DLP or SLA 3D printer thatuses photopolymer materials,it is produced 3Doutput layer by layer. Byreading a STL file whichcontains 3D information ofthe dental prosthesis of apatient's oral cavity, the 3Dprinter can create a | Denture Base Resin is used tofabricated syntheticsubstances that formdenture base afterpolymerization. The denturebase is the part of a denturethat rests on the foundationtissues and to which teethare attached. | Different |
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| SUBJECT Device | REFERENCE Device(K222414) | Significant Difference | |
|---|---|---|---|
| Manufacturer | Graphy Inc. | Graphy Inc. | - |
| Trade Name | TERA HARZ II | TERA HARZ DENTURE |
| Manufacturing Technology | Additive | Additive | Same |
|---|---|---|---|
| Material of Use | Methacrylate-based resinswith photo-initiator, inhibitor andpigments | Methacrylate-based resinswith photo-initiator, inhibitor andpigments | Same : The subject deviceand the reference devicehave the same raw material. |
| Product state | Pre-mixed resin(liquid) | Pre-mixed resin(liquid) | Same |
| Biocompatibility | Biocompatibleaccording to ISO10993-1 | Biocompatibleaccording to ISO10993-1 | Same |
| Performance Testing | ISO 10477:2020 | ISO 20795-1:2013 | Different : The subject deviceand the reference deviceapplied different technicalstandards. |
| OTX or Rx | Rx | Rx | Same |
| Sterile | non-sterile | non-sterile | Same |
| Shelf-life | 2 year | 2 year | Same |
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IX. PERFORMANCE DATA
The following performance data were provided in support of thesubstantial equivalence determination.
Manufacturing Validation
A manufacturing validation was performed to demonstrate themanufacturing process for TERA HARZ II
An independent 3rd party software and digital calipers were used to perform point-topoint and critical displacement measurement.All translational measurements were within 0.150 mm of the target input value, the predefined tolerance of the manufacturing process. There were no statistical differences in the difference in the intended and measured values observed from any of the groups. This test has met the pre-established acceptance criteria.
And the test also conducted studies on the effect of manufacturing validation and material reuse on the properties of the final finished device according to FDA's published guidance documents, "Technical Considerations for Additive Manufactured Medical Devices".
The TERA HARZ II is outputted by each different output condition and each flexural strength were measured and the evaluation criteria of the all the specimens were more than 50 MPa. The optimal output condition is that the output angle is 0°, and the output position is centered to confirming that the optimal condition is to be output. In addition, it was confirmed that there was no problem in the number of effective outputs for repeated material output up to 6 times.
Performance Testing
The predicate devices performed tests for Depth of Cure, Flexural Strength, Water Solubility, Water Sorption, and Biocompatibility content. The predicate/reference devices performed these tests as well and all met the requirements of ISO 10477:2020, Dentistry - Polymerbased crown and veneering materials.
Comparison Performance Testing
Bench testing was performed on both the subject device and the predicate device (K202846) to evaluate critical properties including Flexural strength, Shaede consistency and Color stability, Water sorption,solubility, and depth of cure. All met the requirements of ISO 10477:2020.
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 contact with the mucosal
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membrane for > 30 days. The ISO 10993-1 standard was followed the following biological safety aspects have been addressed:
- –ISO 7405:2018, Dentistry Evaluation of biocompatibility of medical devices used in dentistry
- –ISO 10993-1:2018, Biological evaluation of medical devices Part 1: Evaluation and testing
- -ISO 10993-3:2014, Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- –ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- –ISO 10993-6:2016, Biological evaluation of medical devices Part 6: Tests for local effects after implantation
- –ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
- –ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity
X. CLINICAL DATA
Clinical performance data was not provided for TERA HARZ II.
XI. CONCLUSIONS
The TERA HARZ II is very similar to the predicate device and demonstrate substantial equivalence to predicate device, K202846.
An analysis for subject device compared to the predicate device show TERA HARZ II and
the TERA HARZ II 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 II and the TERA HARZ meet the requirements of ISO 10477:2020, Polymer-based crown and veneering materials 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 value of physical properties . So reference device, which has same composition of raw
materials, is added to support material of use. Also two products meet the requirements of ISO 10477:2020.
Any differences between subject device and the predicate devices are minimal and present no new risks.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.