(1 days)
Not Found
No
The summary describes a light-curable resin for dental prosthetics and the required CAD/CAM system components (digital files, 3D printer, curing light). There is no mention of AI or ML being used in the resin itself, the manufacturing process, or the associated equipment. The focus is on the material properties and the physical manufacturing process.
No.
The TERA HARZ DENTURE is a material (light-curable resin) used for the fabrication and repair of dental prosthetics (dentures), not a device that directly provides therapy.
No
The TERA HARZ DENTURE is a light-curable resin used for the fabrication and repair of dental prosthetics (dentures and baseplates), not for diagnosing medical conditions.
No
The device is a light-curable resin, which is a physical material used in the fabrication of dentures. While it is used in conjunction with a CAD/CAM system and digital files, the device itself is the resin material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fabrication and repair of dental prosthetics (dentures and baseplates). This is a manufacturing process for a medical device that will be placed in the patient's mouth.
- Device Description: The device is a material (light-curable resin) used in a manufacturing process (3D printing) to create a physical object (dentures).
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes.
The TERA HARZ DENTURE does not examine specimens from the human body. It is a material used to create a physical device that will be used in the human body.
N/A
Intended Use / Indications for Use
The TERA HARZ DENTURE is a light-curable resin indication 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 based on a digital impression, digital light processing(DLP) printer, and curing light equipment.
Product codes
EBI
Device Description
The TERA HARZ DENTURE is a light-cured, methacrylate-based resin commonly used in additive manufacturing when producing dental structures (both full and partial dentures).
Methacrylate-based resin is a known material that is often used in the dental industry for fixed and removable prosthetic devices due to its physical-chemical, and biocompatible properties.
The TERA HARZ DENTURE is made from methacrylate-based resins. It is stored in a black 1,000g HDPE bottle. This resin is a liquid photopolymer material that is polymerized by a ultraviolet (UV) laser at 405412 nm. The resin can be used to create customized removable full and partial dentures with a 3D printer cured by UV light. The UV curable liquid resin is cured at a specific wavelength (395405 nm) by the photo-initiator contained in the resin. The process parameters of the 3D printer affect the quality of the 3D printed objects. The printer equipment should be set to a resolution of 40 to 90 um on the x,y axis (horizontal resolution) and 100 µm on the z axis (vertical resolution). The TERA HARZ DENTURE should be used with a specific 3D printer that uses a UV light source and produces 3D printed objects with layer thickness of 100 um.
The TERA HARZ DENTURE does not come with a scanner, design software, 3D printer, or postcure unit.
The TERA HARZ DENTURE can be used to manufacture customized removable full and partial dentures using compatible equipment.
Digital file can be generated by scanning the patient's intraoral region directly with an intraoral scanner or by scanning the teeth model with a model scanner under the FDA Classification Product Code NOF, regulation 872.3661.
The digital file consists of a series of CAD files (.stl) for building 3D models that can be used to create the denture base. Specialized dental software is used to virtually design a denture base and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The design software used is 3Shape Dental System™ under the FDA Classification Product Code NOF, regulation 872.3661. This software is used to manage 3D scanned teeth models, as well as to measure, analyze, examine, and visualize 3D scanned teeth models to design denture models.
STL files are transferred to a 3D printer. Using the *.stl CAD file data, the 3D printer begins additive manufacturing, which is used to create customized 3D printed dentures. The 3D printed dentures are further cured in the post-curing device. Manufactured dentures are polished and washed accordingly.
Before giving the dentures to the patients, the dentist reviews them to ensure the optimal fit and design.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Non-clinical tests were completed: Flexural Strength, Water sorption, and Solubility. Results demonstrated substantial equivalence to the predicate device, meeting ISO 20795-1:2013 requirements.
Manufacturing Validation: Tested specimens printed under different output conditions. Optimal output angle is 45 degrees, and optimal position is the center.
Performance Testing: Included visual inspection, capacity, package integrity, surface characteristics, shape capability, porosity, translucency, color, color stability, flexural strength, flexural modulus, water sorption, water solubility, bonding between resin teeth, total fracture work, maximum stress intensity factor. All met standard criteria.
Shelf Life Testing: Shelf life of 1 year, conducted with bench tests from ISO 20975-1.
Biocompatibility: Performed according to ISO 10993-1, -3, -5, -6, -10, -11 including Cytotoxicity, Sensitization, Intracutaneous reactivity, Irritation, Acute systemic toxicity, Sub-chronic toxicity, Genotoxicity test, and Implantation.
Key Metrics
Flexural strength: Requirements > 65 MPa, Subject Device Average = 94.43 MPa, Predicate Device Average = 92.64 MPa.
Flexural modulus: Requirements > 2,000 MPa, Subject Device Average = 2545.32 MPa, Predicate Device Average = 2362.58 MPa.
Water absorption: Requirements
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
0
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 11, 2022
Graphy Inc. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K222414
Trade/Device Name: Tera Harz Denture Regulation Number: 21 CFR 872.3760 Regulation Name: Denture relining, repairing, or rebasing resin Regulatory Class: Class II Product Code: EBI Dated: August 2, 2022 Received: August 10, 2022
Dear Dave Yungvirt:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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, 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) K222414
Device Name TERA HARZ DENTURE
Indications for Use (Describe)
The TERA HARZ DENTURE is a light-curable resin indication 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 based on a digital impression, digital light processing(DLP) printer, and curing light equipment.
| Brand | Type | |
|---|---|---|
| Intraoral scanner | 3Shape A/S | TRIOS 3 Basic |
| Model scanner | 3Shape A/S | E3 |
| Printing: | ||
| 3D Printer | UNIZ | SLASH 2 |
| SprintRay Inc. | SprintRay Pro 95 | |
| Post-Curing: | ||
| Post-cure unit | CureM | U102H |
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Image /page/3/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and consists of the text "SMB Korea" in a bold, sans-serif font. Underneath the text is the tagline "A Member of the Consulting Expert Group" in a smaller, italicized font. A curved line extends from under the "S" in SMB and underlines the text.
510(k) Summary For TERA HARZ DENTURE [Complying with 21 CFR 807.92]
SUBMISSION SPONSOR l.
Graphy Inc. #603, #617, Ace Gasan Forhu, 225, Gasan digital 1-ro, Geumcheon-gu, Seoul, Republic of Korea Office Phone: +82-2-864-3056 Fax: 82-2-864-3057 Contact Person: Mr. Tae-woo Kim, QMR
II. SUBMISSION CORRESPONDENT
SMB Korea #606, #607, 7, Boramae-ro 5ga-gil, Donjak-gu, Seoul, 07071, Republic of Korea Cell Phone: +82-10-2247-5579 Office Phone: +62-6241-9001 Contact: Kyung-hwan KIM, Representative Consultant, QA Email: info@smbkorea.com
III. DATE PREPARED
March 10, 2022
IV. DEVICE
| Trade or Proprietary Name: | TERA HARZ DENTURE |
|---|---|
| Common or Usual Name: | Denture Base Resin |
| Classification Name: | Denture relining, repairing, or rebasing resin. (872.3760) |
| Regulatory Class: | II |
| Product Code: | EBI |
| Classification Panel: | Dental |
V. PREDICATE DEVICE
Primary Predicate Device: K162044, Dentca Denture Base II / Dentca, Inc.
VI. DEVICE DESCRIPTION
The TERA HARZ DENTURE is a light-cured, methacrylate-based resin commonly used in additive manufacturing when producing dental structures (both full and partial dentures).
4
Image /page/4/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and features the text "SMB Korea" in a bold, sans-serif font. Below the text is the phrase "A Member of the Consulting". The logo is simple and professional, and it is likely used to represent the company's brand.
Methacrylate-based resin is a known material that is often used in the dental industry for fixed and removable prosthetic devices due to its physical-chemical, and biocompatible properties.
The TERA HARZ DENTURE is made from methacrylate-based resins. It is stored in a black 1,000g HDPE bottle. This resin is a liquid photopolymer material that is polymerized by a ultraviolet (UV) laser at 405412 nm. The resin can be used to create customized removable full and partial dentures with a 3D printer cured by UV light. The UV curable liquid resin is cured at a specific wavelength (395405 nm) by the photo-initiator contained in the resin. The process parameters of the 3D printer affect the quality of the 3D printed objects. The printer equipment should be set to a resolution of 40 to 90 um on the x,y axis (horizontal resolution) and 100 µm on the z axis (vertical resolution). The TERA HARZ DENTURE should be used with a specific 3D printer that uses a UV light source and produces 3D printed objects with layer thickness of 100 um.
The TERA HARZ DENTURE does not come with a scanner, design software, 3D printer, or postcure unit.
The TERA HARZ DENTURE can be used to manufacture customized removable full and partial dentures using compatible equipment.
Digital file can be generated by scanning the patient's intraoral region directly with an intraoral scanner or by scanning the teeth model with a model scanner under the FDA Classification Product Code NOF, regulation 872.3661.
The digital file consists of a series of CAD files (.stl) for building 3D models that can be used to create the denture base. Specialized dental software is used to virtually design a denture base and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The design software used is 3Shape Dental System™ under the FDA Classification Product Code NOF, regulation 872.3661. This software is used to manage 3D scanned teeth models, as well as to measure, analyze, examine, and visualize 3D scanned teeth models to design denture models.
STL files are transferred to a 3D printer. Using the *.stl CAD file data, the 3D printer begins additive manufacturing, which is used to create customized 3D printed dentures. The 3D printed dentures are further cured in the post-curing device. Manufactured dentures are polished and washed accordingly.
Before giving the dentures to the patients, the dentist reviews them to ensure the optimal fit and design.
5
Graphy Inc. Traditional 510(k) Premarket Submission TERA HARZ DENTURE
Image /page/5/Picture/1 description: The image contains the word "Photographs" in a bold, sans-serif font. The text is black and appears to be isolated against a white background. The word is presented in a simple, straightforward manner, with no additional design elements or context provided.
Image /page/5/Picture/2 description: The image shows the logo for SMB Korea. The logo is in gray and consists of the letters "SMB" in a bold font, followed by the word "Korea" in a slightly smaller font. A curved line underlines the letters "SMB". Below the main logo, in a smaller font, is the text "A Member of the Consulting Expert Group".
Image /page/5/Picture/3 description: The image shows a pink denture. The denture is a prosthetic device used to replace missing teeth. It is made of a pink acrylic material and has a smooth, polished surface. The denture is designed to fit comfortably in the mouth and provide support for the cheeks and lips.
Figure 1 – TERA HARZ DENTURE – Denture Base View
Accessories for the Product, Integral Parts of Package
Not applicable,
This device does not come with a compatible intraoral or model scanners, design software, 3D printers, post-cure unit, and other accessories used in fabrication.
VII. INDICATION FOR USE
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.
VIII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
To demonstrate safety and effectiveness of the TERA HARZ DENTURE and to show substantial equivalence to the predicate device, the following non-clinical tests were completed: Flexural Strength, Water sorption, and Solubility.
The result of the performance comparison test demonstrates that the TERA HARZ DENTURE is substantially equivalent to the predicate device. Potential minor variance does not introduce additional safety or efficacy concerns. Both devices meet requirements from ISO 20795-1:2013.
The performance characteristics of the TERA HARZ DENTURE are comparable to those of the predicate device for this particular indication and raise no questions on safety and effectiveness.
6
Image /page/6/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and features the text "SMB Korea" in a sans-serif font. Below the text is the tagline "A Member of the Consulting Expert Group" in a smaller font. A curved line extends from under the "S" in SMB and curves up and over the "K" in Korea.
Any differences in technology characteristics are accompanied by information that demonstrates that the device is as safe and as effective as the predicate device and do not raise questions on safety and effectiveness.
Therefore, it is concluded that the technological differences do not raise questions on safety and effectiveness.
| SUBJECT Device | Primary PREDICATE Device | Significant Difference | |
|---|---|---|---|
| Manufacturer | Graphy Inc. | Dentca, Inc. | - |
| Trade Name | TERA HARZ DENTURE | Dentca Denture Base II | - |
| 510(k) No. | - | K162044 | - |
| Regulation | |||
| Description | Resin, Denture, Relining, Repairing, | ||
| Rebasing | Resin, Denture, Relining, Repairing, | ||
| Rebasing | No difference | ||
| Regulation | |||
| Number | 21 CFR 872.3760 | 21 CFR 872.3760 | No difference |
| Product Code | EBI | EBI | No difference |
| Class | II | II | No difference |
| Indications for | |||
| Use | 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. | The DENTCA Denture Base II 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 | |||
| Dentca Denture Base II requires a | |||
| computer-aided design and | |||
| manufacturing (CAD/CAM) system that | |||
| includes the following components: | |||
| digital denture base files based on a | |||
| digital impression, stereolithographic | |||
| additive printer, and curing light | |||
| equipment. | No difference | ||
| Fabrication of | |||
| Denture Base | Automated 3D printing of resin in | ||
| multiple layers, each light-cured before | |||
| adding next layer, with post curing in light | |||
| chamber | Automated 3D printing of resin in | ||
| multiple layers, each light-cured before | |||
| adding next layer, with post curing in | |||
| light chamber | No difference | ||
| Device | |||
| Characteristics | Digital Scan file: STL | ||
| Design software: 3shape dental system | |||
| (NOF) | |||
| Stereolithographic additive printer: | |||
| SPRINTRAY PRO 95 | |||
| Operation software: Rayware | |||
| Curing equipment: CUREM 102H (405nm) | Digital Scan file: STL | ||
| Design software: Dentca Pala Design | |||
| Studio (NOF) | |||
| Stereolithographic additive printer: | |||
| SPRINTRAY PRO 95 | |||
| Operation software: Rayware | |||
| Curing equipment: Pro Cure (405nm) | The design software | ||
| are not equivalent, | |||
| but they are both | |||
| registered on FDA | |||
| with Product Code | |||
| NOF. | |||
| Curing equipment are | |||
| produced by different | |||
| manufacturers, but | |||
| share the same | |||
| wavelengths of | |||
| 405nm. | |||
| Device color | - Clear |
- White
- Light pink
- Pink
- Dark pink
- Black pink | - Light pink
- Original pink
- Reddish pink
- Dark pink | - |
| Materials of Use | Methacrylate-based resins with photo-
initiator, inhibitor and pigments | Methacrylate-based resins with photo-
initiator, inhibitor and pigments | |
| Product State | Pre-mixed resin (liquid) | Pre-mixed resin (liquid) | No difference |
| Design | Image: pink denture | Image: pink denture | No difference |
| Performance
Testing | ISO 20795-1:2013
Requirements: - Flexural strength > 65 MPa.
- Flexural modulus > 2,000 MPa.
- Water absorption ≤ 32 µg/mm3
- Water solubility ≤ 1.6 µg/mm3
Test Results:
- Average Flexural strength = 94.43 MPa
- Flexural modulus: Average 2545.32 MPa
- Average Water absorption=10.30 µg/mm3
- Average Water solubility =1.22 µg/mm3 | ISO 20795-1:2013
Requirements: - Flexural strength> 65 MPa.
- Flexural modulus > 2,000 MPa.
- Water absorption ≤ 32 µg/mm3
- Water solubility ≤ 1.6 µg/mm3
Test Results:
- Average Flexural strength= 92.64 MPa
- Average Flexural modulus = 2362.58 MPa
- Average Water absorption = 10.34 µg/mm3
- Average Water solubility = 1.05 µg/mm3 | The SUBJECT Device
has higher Flexural
strength, Flexural
modulus, and Water
solubility than the
Primary PREDICATE
Device, but showed
lower water
absorption. There
was no significant
difference in their
performance testing
results between the
two devices, and they
all satisfied the
required standards
from ISO 20795-
1:2013. |
| Biocompatibility | Biocompatible according to ISO 10993 | Biocompatible according to ISO 10993 | |
| Sterile | Non-sterile | Non-sterile | No difference |
| Shelf-life | 1 years | 2 years | - |
7
Graphy Inc. Traditional 510(k) Premarket Submission TERA HARZ DENTURE
Image /page/7/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and features the text "SMB Korea" in a bold, sans-serif font. A curved line extends from the bottom left of the "M" in SMB, arching upwards and to the right, ending above the "K" in Korea. Below the main text, there is smaller text that reads "A Member of the Consulting".
IX. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Manufacturing Validation
A manufacturing validation was performed with the following printer(s) to demonstrate Page 5-7
8
Image /page/8/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and features the text "SMB Korea" in a sans-serif font. Below the text is the tagline "A Member of the Consulting Expert Group" in a smaller, italicized font. A curved line extends from the bottom of the "S" in SMB, underlining the text.
the manufacturing process for the TERA HARZ DENTURE:
| Brand | Model | Remark | |
|---|---|---|---|
| Design: | |||
| Intraoral scanner | 3Shape A/S | TRIOS 3 Basic | |
| Model scanner | 3Shape A/S | E3 | |
| Design software | 3Shape A/S | 3Shape Dental System | |
| Additive Manufacturing System: | |||
| 3D Printer | SprintRay Inc. | SprintRay Pro 95 | |
| UNIZ | SLASH 2 | SKU: | |
| ZSLP1012001 | |||
| Post-Curing: | |||
| Post-cure unit | CureM | U102H |
The test was conducted to evaluate the effect of manufacturing validation and material reuse on the properties of the final finished device according to the FDA's published guidance document, "Technical Considerations for Additive Manufactured Medical Devices".
The test specimens made of TERA HARZ DENTURE were printed under different output conditions and each specimen was measured using the evaluation criteria of a flexural strength greater than 65 MPa and flexural modulus greater than 2000 MPa. All specimens met the criteria. The optimal output angle is 45 degrees, and the optimal position is the center.
In addition, the repeated usage of the material met the criteria for flexural strength and modulus when reused up to 6 times.
Performance Testing
Performance tests in accordance with ISO 20795-1 including visual inspection, capacity, package integrity, surface characteristics, shape capability, porosity, translucency, color, color stability, flexural strength, flexural modulus, water sorption, water solubility, bonding between resin teeth, total fracture work, maximum stress intensity factor were performed. The results of the non-clinical tests demonstrate that the results have met the standard criteria, and the subject device is substantially equivalent to the predicate device.
Shelf Life Testing
The Shelf Life Testing Subject device has a shelf life of 1 year. Shelf-life testing has been conducted with the bench tests from ISO 20975-1.
Biocompatibility
Biocompatibility Tests in accordance with the FDA Guidance Document, Use of
9
Graphy Inc. Traditional 510(k) Premarket Submission TERA HARZ DENTURE
Image /page/9/Picture/1 description: The image contains the logo for SMB Korea. The logo is in gray and features the text "SMB Korea" in a stylized font. Below the main text, there is a smaller line of text that reads "A Member of the Consulting Expert Group."
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 in contact with the mucosal membrane for > 30 days. The ISO 10993-1 standard was followed and the following biological safety aspects have been addressed:
Cytotoxicity in accordance with ISO 10993-5
Sensitization in accordance with ISO 10993-10
Intracutaneous reactivity in accordance with ISO 10993-10
Irritation in accordance with ISO 10993-10
Acute systemic toxicity in accordance with ISO 10993-11
Sub-chronic toxicity in accordance with ISO 10993-11
Genotoxicity test in accordance with ISO 10993-3
Implantation in accordance with ISO 10993-6
X. CLINICAL DATA
Clinical performance data was not provided for the TERA HARZ DENTURE.
XI. CONCLUSIONS
The test results of the non-clinical tests performed on the subject device supported that the device is substantially equivalent to the predicate devices despite the differences. Based on the information provided in this premarket notification, Graphy Inc. concludes that the TERA HARZ DENTURE is substantially equivalent to the predicate device as described herein.