(1 days)
No
The summary describes a resin material used in a CAD/CAM system for dental restorations. While it mentions design software and 3D printing, there is no indication of AI or ML being used in the material itself or the described manufacturing process. The software mentioned is standard dental design software.
Yes.
The device is a material for fabricating permanent or temporary dental restorations, which are used to treat anatomical defects (missing or damaged teeth), thereby restoring function and form. This falls under the definition of a therapeutic device as it treats a condition.
No
The device is a material (resin) used for fabricating dental restorations (crowns, bridges, etc.), which are treatment devices, not diagnostic ones. It does not perform any diagnostic function.
No
The device is a light-cured, methacrylate oligomer based polymerizable resin, which is a physical material used in a 3D printing process. While it is used in conjunction with software and hardware, the device itself is the resin material.
Based on the provided information, the TERA HARZ II device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for fabricating indirect dental restorations (crowns, bridges, inlays, onlays, veneers). This is a restorative purpose, not a diagnostic one.
- Device Description: The device is a material (resin) used in a CAD/CAM system to create physical dental prosthetics. It is not used to test or analyze biological samples for diagnostic purposes.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, diagnose, monitor, or predict any disease or condition by examining samples from the human body.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the fabricated restorations (flexural strength, water sorption, etc.) and biocompatibility, which are relevant to a restorative device, not an IVD.
In summary, TERA HARZ II is a material used to create dental prosthetics, which falls under the category of a dental restorative device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
EBF, EBG
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior restorations, including occlusal surfaces.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist or dental technician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 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
Key Metrics
- Depth of Cure (%): Avg. 91.3 (subject device), Avg. 93.5 (predicate device)
- Flexural Strength (MPa): Avg. 125.5 (subject device), Avg. 148.73 (predicate device)
- Water sorption (µg/mm3): Avg. 22.03 (subject device), Avg. 13.03 (predicate device)
- Solubility (µg/mm3): Avg. 0.12 (subject device), Avg. 1.00 (predicate device)
- Shade consistency: The difference in color from different bataches was not observed.
- Color stability: Any color change after aging treatments was not detected.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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.
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)
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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3
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.
4
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 | CureM | |
| TERA HARZ CURE | U102H | |
| THC2 |
6
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
7
| | SUBJECT Device | Primary PREDICATE
Device (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 | EBF
EBG | EBF
EBG | Same |
| Class | II | II | Same |
| Indication for Use | TERA HARZ II is indicated
as an indirect
restorative for both
anterior and posterior
restorations, including
occlusal surfaces.
The TERA HARZ
material is used for
fabricating temporary
or permanent
restorations such as
crowns and bridges,
inlays, onlays, veneers
and full crown
restorations.
Fabrication of TERA
HARZ requires a
computer-aided and
manufacturing
(CAD/CAM) system
that includes the
following: scanner,
design software,
additive printer, and
post-cure unit. | TERA HARZ is indicated
as an indirect
restorative for both
anterior and posterior
restorations, including
occlusal surfaces.
The TERA HARZ
material is used for
fabricating temporary
or permanent
restorations such as
crowns and bridges,
inlays, onlays, veneers
and full crown
restorations.
Fabrication of TERA
HARZ requires a
computer-aided and
manufacturing
(CAD/CAM) system
that includes the
following: scanner,
design software,
additive printer, and
post-cure unit. | Similar: The indication for
use of the subject device is
very similar to the predicate
device. |
| Mechanism of Action | The product is a
photopolymer liquid resin
that is manufactured to
produce
an output within UV lighting
3D printer. The material is for
producing
polymeric dental prosthesis
according to ISO 10477, type
2 and class 2. Using
a DLP or SLA 3D printer that
uses photopolymer materials,
it is produced 3D
output layer by layer. By
reading a STL file which
contains 3D information of
the dental prosthesis of a
patient's oral cavity, the 3D
printer can create a | The product is a
photopolymer liquid resin
that is manufactured to
produce
an output within UV lighting
3D printer. The material is for
producing
polymeric dental prosthesis
according to ISO 10477, type
2 and class 2. Using
a DLP or SLA 3D printer that
uses photopolymer materials,
it is produced 3D
output layer by layer. By
reading a STL file which
contains 3D information of
the dental prosthesis of a
patient's oral cavity, the 3D
printer can create a | Same |
8
| | SUBJECT Device | Primary PREDICATE
Device (K202846) | Significant Difference |
|--------------|----------------|---------------------------------------|------------------------|
| Manufacturer | Graphy Inc. | Graphy Inc. | - |
| Trade Name | TERA HARZ II | TERA HARZ | |
| | continuous layer. When the
3D printer emits light to
the resin with specific pattern
of a shape, the photoinitiator
in the resin
absorbs the pattern of UV
wavelength band. It causes a
photocuring reaction
in a pattern shape and the
photopolymer resin is
curedlayer by layer and it is
continuously carried out to
produce the shape that you
want. The operation | continuous layer. When the
3D printer emits light to
the resin with specific pattern
of a shape, the photoinitiator
in the resin
absorbs the pattern of UV
wavelength band. It causes a
photocuring reaction
in a pattern shape and the
photopolymer resin is
curedlayer by layer and it is
continuously carried out to
produce the shape that you
want. The operation | |
|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | is carried out continuously | is carried out continuously | |
| | and finally the output are
produced. | and finally the output are
produced. | |
| Manufacturing Technology | Additive | Additive | Same |
| Material of Use | Methacrylate-based resins
with photo-
initiator, inhibitor and
pigments | Methacrylate polymer
resin (dimethacrylate) | Different : the subject device
differs from the predicate
device in the material of use.
The two products are similar
methacrylate-based resins,
but they differ slightly in raw
material composition. |
| Product state | Pre-mixed resin(liquid) | Pre-mixed resin(liquid) | Same |
| Biocompatibility | Biocompatible
according to ISO
10993-1 | Biocompatible
according to ISO
10993-1 | Same |
| Performance Testing | ISO 10477:2020 | ISO 10477:2020 | Same : the subject device
and predicate device have
same performance testing
standard |
| Depth of Cure (%)
(Bottom surface shall be not
less than 70% of the
hardness of top surface) | Avg. 91.3 | Avg. 93.5 | Similar : the specifications
are in the same range. This
minor variance does not
introduce additional safety o
efficacy concerns. |
| Flexural Strength
(≥50 MPa; ISO 10477) | Avg. 125.5 | Avg. 148.73 | Similar : the specifications
are in the same range. This
minor variance does not
introduce additional safety o
efficacy concerns. |
| Water sorption
(≤40µg/mm3) | Avg. 22.03 | Avg. 13.03 | Similar : the specifications
are in the same range. This
minor variance does not
introduce additional safety o
efficacy concerns. |
| Solubility
(≤7.5 µg/mm3) | Avg. 0.12 | Avg. 1.00 | Similar : the specifications
are in the same range. This
minor variance does not
introduce additional safety o
efficacy concerns. |
9
| | SUBJECT Device | Primary PREDICATE
Device (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 |
10
| | 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 | EBF
EBG | EBI | Different |
| Class | II | II | Same |
| Indication for Use | TERA HARZ II is indicated as an indirect
restorative for both anterior and posterior
restorations, including occlusal surfaces.
The TERA HARZ material is used for
fabricating temporary or permanent
restorations such as crowns and bridges,
inlays, onlays, veneers and full crown
restorations.
Fabrication of TERA HARZ requires a
computer-aided and manufacturing
(CAD/CAM) system that includes the
following: scanner, design software,
additive printer, and post-cure unit. | The TERA HARZ DENTURE is a
light-
curable resin indicated for fabrication and
repair of full and partial removable
dentures and baseplates. The material is
an alternative to traditional heat-curable
and auto polymerizing resins. Fabrication
of dental prosthetics with the TERA HARZ
DENTURE requires a computer-aided
design and manufacturing (CAD/CAM)
system that includes the following
components: digital denture base files
based on digital impression,
stereolithographic additive printer, and
curing light equipment. | Different: The indication for
use of the subject device is
different from the reference
device. |
| Mechanism of Action | The product is a
photopolymer liquid resin
that is manufactured to
produce
an output within UV lighting
3D printer. The material is for
producing
polymeric dental prosthesis
according to ISO 10477, type
2 and class 2. Using
a DLP or SLA 3D printer that
uses photopolymer materials,
it is produced 3D
output layer by layer. By
reading a STL file which
contains 3D information of
the dental prosthesis of a
patient's oral cavity, the 3D
printer can create a | Denture Base Resin is used to
fabricated synthetic
substances that form
denture base after
polymerization. The denture
base is the part of a denture
that rests on the foundation
tissues and to which teeth
are attached. | Different |
11
| | 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 resins | ||
| with photo- | |||
| initiator, inhibitor and | |||
| pigments | Methacrylate-based resins | ||
| with photo- | |||
| initiator, inhibitor and | |||
| pigments | Same : The subject device | ||
| and the reference device | |||
| have the same raw material. | |||
| Product state | Pre-mixed resin(liquid) | Pre-mixed resin(liquid) | Same |
| Biocompatibility | Biocompatible | ||
| according to ISO | |||
| 10993-1 | Biocompatible | ||
| according to ISO | |||
| 10993-1 | Same | ||
| Performance Testing | ISO 10477:2020 | ISO 20795-1:2013 | Different : The subject device |
| and the reference device | |||
| applied different technical | |||
| standards. | |||
| OTX or Rx | Rx | Rx | Same |
| Sterile | non-sterile | non-sterile | Same |
| Shelf-life | 2 year | 2 year | Same |
12
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
13
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.