(293 days)
No
The summary describes a dental resin used in a CAD/CAM system for 3D printing dental restorations. While it mentions design software and scanning, there is no indication that AI or ML is used within the resin material itself or the described manufacturing process. The software mentioned is standard dental design software.
No.
The device is a material (resin) used for fabricating dental restorations (e.g., crowns, bridges, inlays, onlays, veneers), which are prosthetic devices, not therapeutic devices.
No
Explanation: The device, TERA HARZ, is a material (resin) used for fabricating dental restorations (e.g., crowns, bridges) via a CAD/CAM system and 3D printing. It is a restorative material and not a device that identifies, monitors, or diagnoses a patient's condition.
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 (scanner, design software), the device itself is a material, not software.
Based on the provided information, the TERA HARZ device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use of TERA HARZ is for fabricating indirect dental restorations (crowns, bridges, inlays, onlays, veneers). This is a therapeutic and restorative purpose, not a diagnostic one.
- Device Description: The device is a material (resin) used in a manufacturing process (CAD/CAM 3D printing) to create physical dental prosthetics. It does not perform any tests on biological samples or provide information about a patient's health status.
- Lack of Diagnostic Function: The description focuses on the material properties, the manufacturing process, and the resulting physical restoration. There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information.
- Regulatory Classification: The predicate and reference devices (K201668 and K193553) are classified as dental materials or devices used in dental restoration, not IVDs.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. TERA HARZ does not fit this definition. It is a material used to create a medical device (a dental restoration) that is implanted or placed in the body.
N/A
Intended Use / Indications for Use
TERA HARZ is indicated as an indirect restorative for both anterior 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.
Product codes (comma separated list FDA assigned to the subject device)
EBF, EBG
Device Description
The TERA HARZ is a light-cured, methacrylate 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 occlusal surfaces, such as temporary or permanent crowns and bridges, inlays, onlays and veneers. Methacrylate based resin is known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical, mechanical and biocompatible properties.
The TERA HARZ 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. 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 100μm 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 can be used in combination with specified lasers and DLP based 3D printers which support dental materials. TERA HARZ is a resin for the generative production of permanent or temporary dental restorations based on image projection systems (405-412 nm). The formulation of TERA HARZ is optimized for the requirements of a robust production guaranteeing constant high quality. The TERA HARZ 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 stereolithographic 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.
3D printer is not included with the device.
These fabrications of TERA HARZ 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, 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 restorations, including occlusal surfaces
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist or dental technician; dental clinician
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Manufacturing Validation:
A manufacturing validation was performed to demonstrate the manufacturing process for TERA HARZ.
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.
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 were outputted by each different output condition and each flexural strength were measured and the evaluation criteria of 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.
It was confirmed that there was no problem in the number of effective outputs for repeated material output up to 7 times.
Performance Testing:
The predicate/reference devices performed tests for Flexural Strength, Flexural Modulus, Water Solubility, Water Sorption, and Biocompatibility content. The predicate/reference devices performed these tests as well and all met the requirements of ISO 4049:2013, Dentistry - Polymer-based restorative materials, and ISO 10477:2018, Dentistry -Polymer-based crown and veneering materials.
Biocompatibility:
A biocompatibility discussion was conducted. The TERA HARZ uses the Dimethacrylatebased resins and this material has been tested and shown to be compliant with the following standards:
- । 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 (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural Strength: Avg. 148.73 MPa (≥100 MPa; ISO 4049, ≥50 MPa; ISO 10477)
Water sorption: Avg. 13.03 µg/mm³ (≤40 µg/mm³)
Solubility: Avg. 1.00 µg/mm³ (≤7.5 µg/mm³)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Image /page/0/Picture/0 description: The image shows 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.
July 15, 2021
Graphy Inc. % Peter Chung Representative Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213
Re: K202846
Trade/Device Name: TERA HARZ Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF, EBG Dated: June 22, 2021 Received: June 23, 2021
Dear Peter Chung:
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.
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
1
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202846
Device Name TERA HARZ
Indications for Use (Describe)
TERA HARZ is indicated as an indirect restorative for both anterior 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.
| 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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3
510(k) Summary For
TERA HARZ
K202846
[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. Tae-woo Kim, QMR
II. SUBMISSION CORRESPONDENT
Plus Global 300, Atwood Street, Pittsburgh, PA, 15213, USA
Office Phone: 412-687-3976
Contact: Mr. Peter Chung, Representative Email: peterchung210@gmail.com
III. DATE PREPARED
July 12, 2021
IV. DEVICE
| Trade or Proprietary Name: | TERA HARZ |
|---|---|
| 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:
K201668, Tooth shade resin material / BEGO Bremer Goldschlägerei Wilh. Herbst GmbH
4
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& Co. KG
Reference device:
K193553, Temporary Crown and Bridge Resin / BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG
VI. DEVICE DESCRIPTION
The TERA HARZ is a light-cured, methacrylate 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 occlusal surfaces, such as temporary or permanent crowns and bridges, inlays, onlays and veneers. Methacrylate based resin is known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical, mechanical and biocompatible properties.
The TERA HARZ 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. 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 100μm 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 can be used in combination with specified lasers and DLP based 3D printers which support dental materials. TERA HARZ is a resin for the generative production of permanent or temporary dental restorations based on image projection systems (405-412 nm). The formulation of TERA HARZ is optimized for the requirements of a robust production guaranteeing constant high quality. The TERA HARZ 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 stereolithographic 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.
5
Image /page/5/Picture/0 description: The image contains the word "Graphy" in a bold, sans-serif font. The color of the text is a vibrant orange. The word is presented in a straightforward manner, with each letter clearly legible and evenly spaced.
3D printer is not included with the device.
These fabrications of TERA HARZ 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, 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.
VII. INDICATION FOR USE
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 permanent or temporary 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 postcure unit.
6
Image /page/6/Picture/0 description: The image shows the word "Graphy" in a bold, sans-serif font. The color of the text is a vibrant orange. The word is presented in a simple, clean design against a white background.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VIII. DEVICE
The following table compares the TERA HARZ to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. 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.
| | Primary PREDICATE
Device (K201668) | REFERENCE Device
(K193553) | SUBJECT Device
(K202846) | Discussion |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | BEGO Bremer
Goldschlägerei Wilh.
Herbst GmbH & Co.
KG | BEGO Bremer
Goldschlägerei Wilh.
Herbst GmbH & Co.
KG | Graphy Inc. | — |
| Trade Name | VarseoSmile Crown
Plus | VarseoSmile Temp | TERA HARZ | — |
| Regulation
Description | Tooth shade resin
material | Temporary Crown and
Bridge Resin | Temporary Crown,
Bridge Resin and Tooth
Shade | No difference. |
| Regulation Number | 21 CFR 872.3690 | 21 CFR 872.3770 | 21 CFR 872.3770
21 CFR 872.3690 | No difference. |
| Product Code | EBF | EBG | EBG, EBF | No difference. |
| Class | II | II | II | No difference. |
| Indications for Use | VarseoSmile Crown
plus is indicated as an
indirect restorative for
both anterior and
posterior restorations,
including occlusal
surfaces. The
VarseoSmile Crown
plus material is used
for fabricating
permanent
restorations such as
inlays, onlays, veneers
and full crown
restorations. | VarseoSmile Temp
resin is indicated for
the fabrication of
temporary dental
restorations in
conjunction with
extraoral light-curing
equipment. | 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. | Similarities: Indication
for use of the subject
device is slightly
different from the
primary predicate in
phrase but
fundamental
indication is the
identical. |
| Manufacturing | 3D liquid (light-cured) | 3D liquid (light-cured) | 3D liquid (light-cured) | No difference. |
| | Primary PREDICATE
Device (K201668) | REFERENCE Device
(K193553) | SUBJECT Device
(K202846) | Discussion |
| Manufacturer | BEGO Bremer
Goldschlägerei Wilh.
Herbst GmbH & Co.
KG
CAD/CAM | BEGO Bremer
Goldschlägerei Wilh.
Herbst GmbH & Co.
KG
CAD/CAM | Graphy Inc.
CAD/CAM | — |
| Material | Methacrylate polymer
resin (dimethacrylate) | Methacrylate polymer
resin (dimethacrylate) | Methacrylate polymer
resin (dimethacrylate) | No difference. |
| Material Shades | Common VITA-shades | Common VITA-shades | Common VITA-shades | No difference. |
| Biocompatibility | Biocompatible
according to ISO
10993-1 | Biocompatible
according to ISO
10993-1 | Biocompatible
according to ISO
10993-1 | No difference. |
| OTC or Rx | Rx | Rx | Rx | No difference. |
| Sterile | Non-sterile | Non-sterile | Non-sterile | No difference. |
| Chemical Composition | Methacrylate polymer
resin with photo
initiator, inhibitor and
pigments | Methacrylate polymer
resin with photo
initiator, inhibitor and
pigments | Polyurethane Resin;
Methacrylate;
Dimethacrylate;
Phosphine oxide;
Butylated
hydroxytoluene; and
Pigments | Similarities: The
subject and predicate
or reference devices
are very similarities in
they are all polymer
resins. Slight
differences in chemical
composition do not
change the intended
use of the subject,
predicate and
reference devices to
be used in the
fabrication of dental
prostheses. The
material is an
alternative to
traditional heat cured
and auto
polymerization resins. |
| Flexural Strength
(≥100 MPa; ISO 4049,
≥50 MPa; ISO 10477) | ≥ 100 MPa | ≥100 MPa | Avg. 148.73 MPa | Similarities: the
specifications are in
the same range. This
minor variance does
not introduce
additional safety or
efficacy concerns.
Both devices meet
requirements from ISO
4049:2019 and ISO
14077:2018. |
| Water sorption (≤40
µg/mm³) | ≤40 µg/mm³ | ≤40 µg/mm³ | Avg. 13.03 µg/mm³ | Similarities: the
specifications are in
the same range. This
minor variance does
not introduce
additional safety or
efficacy concerns. |
| | Primary PREDICATE
Device (K201668) | REFERENCE Device
(K193553) | SUBJECT Device
(K202846) | Discussion |
| Manufacturer | BEGO Bremer
Goldschlägerei Wilh.
Herbst GmbH & Co.
KG | BEGO Bremer
Goldschlägerei Wilh.
Herbst GmbH & Co.
KG | Graphy Inc. | — |
| | | | | requirements from ISO
4049:2019 and ISO
14077:2018. |
| Solubility (≤7.5
µg/mm³) | ≤7.5 µg/mm³ | ≤7.5 µg/mm³ | Avg. 1.00 µg/mm³ | Similarities: the
specifications are in
the same range. This
minor variance does
not introduce
additional safety or
efficacy concerns.
Both devices meet
requirements from ISO
4049:2019 and ISO
14077:2018. |
7
Graphy
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Image /page/8/Picture/0 description: The image shows the word "Graphy" in a bold, sans-serif font. The color of the text is a vibrant orange. The word is presented on a white background, which makes the text stand out.
IX. NON-CLINICAL 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.
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 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 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 7 times.
9
Image /page/9/Picture/0 description: The image shows the word "Graphy" in a bold, sans-serif font. The color of the text is a vibrant orange. The word is presented in a simple, clean design against a white background.
Performance Testing
The predicate/reference devices performed tests for Flexural Strength, Flexural Modulus, Water Solubility, Water Sorption, and Biocompatibility content. The predicate/reference devices performed these tests as well and all met the requirements of ISO 4049:2013, Dentistry - Polymer-based restorative materials, and ISO 10477:2018, Dentistry -Polymer-based crown and veneering materials.
Biocompatibility
A biocompatibility discussion was conducted. The TERA HARZ uses the Dimethacrylatebased resins and this material has been tested and shown to be compliant with the following standards:
- । 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
The performance of methacrylate-based polymer resins in the clinical environment has been well established. No clinical data is included in this submission.
XI. CONCLUSIONS
The TERA HARZ is very similar to both predicate devices and demonstrate substantial equivalence to predicate/reference devices K201668 and K193553.
An analysis for subject device compared to the predicate device show TERA HARZ and the Resin for Temporary Crown & Bridge meet 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 and the Resin for Temporary Crown & Bridge meet the requirements of ISO 10477:2018, Dentistry - Polymer-based crown and veneering materials and ISO 4049:2013, Dentistry - Polymer-based restorative materials. All two devices meet or
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exceed the minimum strength requirements, and all two are biocompatible. Any differences between subject device and the predicate devices are minimal and present no new risks.