(385 days)
No
The summary describes a dental restorative material used in a CAD/CAM system, but there is no mention of AI or ML in the device description, intended use, or performance studies. The CAD/CAM system itself might utilize AI/ML in its design software, but the device being cleared (the material) does not incorporate these technologies.
No
The device is a material used for fabricating restorations like crowns and bridges, which are mechanical replacements for damaged dental structures. It does not exert a therapeutic effect on the body but rather serves as a prosthesis.
No
This device is a material used for fabricating dental restorations (e.g., crowns, bridges) and does not perform diagnostic functions. It is a restorative material used in conjunction with a CAD/CAM system, not a tool for diagnosing conditions.
No
The device is a physical material (light-cured, methacrylate oligomer based polymerizable resin) used in conjunction with a CAD/CAM system for fabricating dental restorations. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for fabricating dental restorations (crowns, bridges, inlays, onlays, veneers) for use in the mouth. This is a direct application to the patient's body.
- Device Description: The device is a material used in a CAD/CAM system to create these restorations. It's a physical material that becomes part of the patient's dental structure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device is a dental restorative material used in a manufacturing process to create patient-specific dental prosthetics.
N/A
Intended Use / Indications for Use
The C&B NFH Hybrid is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The C&B NFH Hybrid material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restoration of C&B NFH Hybrid 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 C&B NFH Hybrid 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 physicalchemical, mechanical and biocompatible properties.
For the C&B NFH Hybrid, the bonding agent needed to affix the device to performed teeth.
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 (dental)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing: The C&B NFH Hybrid is very similar to the predicate devices and demonstrate substantial equivalence to predicate devices K202846. An analysis for subject device compared to the predicate device show C&B NFH Hybrid and the predicate device 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 C&B NFH Hybrid and predicate resin meet the requirements ISO 10477:2020, Dentistry - Polymer-based crown and veneering materials. and ISO 4049:2013, Dentistry - Polymer-based restorative materials.
Biocompatibility: The biocompatibility discussion was conducted. The C&B NFH Hybrid uses the Dimethacrylate based resins and this material has been tested and shown to be compliant with the following standards: ISO 7405:2018, ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017, ISO 10993-12:2021, ISO 10993-23:2021.
Shelf-Life: The tests to validate the Shelf-Life of the device through the proposed Shelf-Life were conducted using the accelerated aging method in accordance to ASTM F1980 and test results validated 2 years Shelf-Life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural Strength: Avg. 114.32 MPa (subject device), Avg. 148.73 MPa (predicate device)
Water sorption: Avg. 31.32 µg/mm³ (subject device), Avg. 13.03 µg/mm³ (predicate device)
Solubility: Avg. 5.59 µg/mm³ (subject device), Avg. 1.00 µg/mm³ (predicate device)
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 11, 2024
Arum Dentistry Co., Ltd. Boyeon Lim Assistant Manager 23, Gukjegwahak 11-ro, Yuseong-gu Daeieon, 34002 Korea, South
Re: K232559
Trade/Device Name: C&B NFH Hybrid Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF, EBG Dated: August 9, 2024 Received: August 9, 2024
Dear Boyeon Lim:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Bobak FDA Shirmohamm adi -S
For Michael E. Adjodha, M.ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name C&B NFH Hybrid
Indications for Use (Describe)
The C&B NFH Hybrid is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The C&B NFH Hybrid material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restoration of C&B NFH Hybrid 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of a geometric shape on the left and the text "ARUM DENTISTRY" on the right. The geometric shape is made up of two triangles, one red and one light orange, arranged to form a larger triangle.
510(k) Summary - K232559
Submitter
ARUM DENTISTRY Co., Ltd. Boyeon Lim 23, Gukjegwahak 11-ro, Yuseong-gu Daejeon, 34002 Republic of Korea Email: arum_ra@arumdentistry.com Tel. +82-42-935-3644 Fax. +82-42-935-3633
Device Information
- . Trade Name: C&B NFH Hybrid
- . Classification Name: Tooth shade resin material (21 CFR 872.3690), Crown and Bridge, Temporary, Resin (21 CFR 872.3770)
- . Product Code: EBF, EBG
- . Panel: Dental
- Device Class: Class II ●
- Date Prepared: 09/11/2024 ●
Predicate Devices
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
- K202846, TERA HARZ by Graphy Inc. .
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Image /page/5/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of two triangles on the left side, one red and one yellow. To the right of the triangles, the words "ARUM" and "DENTISTRY" are written in a bold, dark brown font, with "DENTISTRY" appearing below "ARUM".
General Description
The C&B NFH Hybrid 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 physicalchemical, mechanical and biocompatible properties.
For the C&B NFH Hybrid, the bonding agent needed to affix the device to performed teeth.
Dental Cement
K193260, U-Cem Premium & MAZIC Cem by Vericom Co., Ltd.
Specific Manufacturing considerations
-
- Digital file
- File format: STL file
- File size should be upload-able in the 3D printer operation software
-
- Printer
- Laser wavelength: 385 nm ~ 405 nm
- Light source: Photopolymerization
- Build speed: 50 µm layer height (1.4 Second), 100 µm layer height (1.9 seconds)
- Build path: line drawing path or surface layer drawing path
-
- Printing parameters
| Printer Model | Layer Thickness
(micron) | Recommended
orientation angle
(degree) | Support point
size(mm) | Support density |
|---------------|-----------------------------|----------------------------------------------|---------------------------|-----------------|
| ARUM LCD | 50-100 | 45° | 0.2 | 50% |
4. Environmental conditions
- Temperature: 18 30 °C
- Relative Humidity: 30 90 %
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Image /page/6/Picture/0 description: The image shows the logo for Arum Dentistry. The logo consists of a red triangle and a tan triangle on the left side of the image. To the right of the triangles is the text "ARUM DENTISTRY" in bold, black letters. Below the text is the phrase "Indication for Use".
The C&B NFH Hybrid is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The C&B NFH Hybrid material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of C&B NFH Hybrid requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and postcure unit.
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Image /page/7/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of a red triangle and a smaller tan triangle on the left side. To the right of the triangles, the words "ARUM" and "DENTISTRY" are written in bold, black letters, with "DENTISTRY" on the second line.
Summaries of Technology Characteristics
The following table compares the C&B NFH Hybrid to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The devices provides more detailed information regarding the basis for the determination of subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.
| Subject Device | Predicate Device | |
|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | Graphy Inc. |
| Device Name | C&B NFH Hybrid | TERA HARZ |
| 510(k) Number | N/A | K202846 |
| Intended Use/ | ||
| Indications for use | C&B NFH Hybrid is indicated as an indirect | |
| restorative for both anterior and posterior | ||
| restorations, including occlusal surfaces. The C&B | ||
| NFH Hybrid material is used for fabricating | ||
| temporary or permanent restorations such as | ||
| crowns and bridges, inlays, onlays, veneers and | ||
| full crown restorations. Fabrication of C&B NFH | ||
| Hybrid 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. | ||
| Manufacturing | ||
| Technology | 3D liquid (light-cured) print resin for dental | |
| CAD/CAM | 3D liquid (light-cured) print resin for dental | |
| CAD/CAM | ||
| Chemical composition | Trimethylolpropane Trimethacrylate | |
| Diphenyl phosphine Oxide | ||
| Urethane Dimethacrylate | ||
| Titanium dioxide | ||
| Pigments | Polyurethane Resin; | |
| Methacrylate; | ||
| Dimethacrylate; | ||
| Phosphine oxide; | ||
| Butylated Hydroxytoluene | ||
| Pigments |
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Image /page/8/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of a red triangle and a smaller yellow triangle on the left side of the image. To the right of the triangles is the text "ARUM" in bold, followed by "DENTISTRY" in bold on the line below.
| Sterilization | Non-Sterile | Non-Sterile |
|---|---|---|
| Flexural Strength | ||
| (≥50 MPa; ISO10477 | ||
| ≥100Mpa; ISO 4049) | Avg. 114.32 MPa | Avg. 148.73 MPa |
| Water sorption | ||
| (≤40 µg/mm³) | Avg. 31.32 µg/mm³ | Avg. 13.03 µg/mm³ |
| Solubility | ||
| (≤7.5 µg/mm³) | Avg. 5.59 µg/mm³ | Avg. 1.00 µg/mm³ |
| Material Shades | A1 ~ A3 | A1 ~ A3 |
| Substantial Equivalent | ||
| Discussion | 1. Similarities | |
| The subject and predicate or reference devices are very similarities in they are all polymer resins. The | ||
| specifications of flexural strength, water sorption and solubility are in the same range. This minor variance | ||
| does not introduce additional safety or efficacy concerns. Both devices meet requirements from ISO | ||
| 10477:2020, Dentistry - Polymer-based crown and veneering materials. and ISO 4049:2013, | ||
| Dentistry - Polymer-based restorative materials |
- Differences
Compared with the primary predicate, the 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. | |
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Image /page/9/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of a red triangle and a smaller tan triangle on the left side of the image. To the right of the triangles is the text "ARUM" in bold, followed by "DENTISTRY" in bold on the line below.
Non-Clinical Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Performance Testing
The C&B NFH Hybrid is very similar to the predicate devices and demonstrate substantial equivalence to predicate devices K202846. An analysis for subject device compared to the predicate device show C&B NFH Hybrid and the predicate device 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 C&B NFH Hybrid and predicate resin meet the requirements ISO 10477:2020, Dentistry - Polymer-based crown and veneering materials. and ISO 4049:2013, Dentistry - Polymer-based restorative materials.
Biocompatibility
The biocompatibility discussion was conducted. The C&B NFH Hybrid uses the Dimethacrylate based 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 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro
cytotoxicity -
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
– ISO 10993-12:2021, Biological evaluation of medical devices – Part 12: Sample preparation and reference materials
- ISO 10993-23:2021, Biological evaluation of medical devices - Part 23: Tests for irritation
Shelf-Life
The tests to validate the Shelf-Life of the device through the proposed Shelf-Life were conducted using the accelerated aging method in accordance to ASTM F1980 and test results validated 2 years Shelf-Life.
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Image /page/10/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of a red triangle and a yellow triangle on the left side of the image. To the right of the triangles, the words "ARUM" and "DENTISTRY" are written in bold, black letters.
Conclusion
The C&B NFH Hybrid is very similar to both predicate devices and demonstrate substantial equivalence to predicate device K202846.
An analysis for subject device compared to the predicate device show the C&B NFH Hybrid and the TERA HARZ meet all two devices share the same product code, met the requirements, and all two are biocompatible.
In addition, an analysis for subject device compared to the predicate device show the C&B NFH Hybrid and the TERA HARZ meet the requirements for ISO 10477:2020, Dentistry – Polymer-based crown and veneering materials and ISO 4049:2013, Dentistry - Polymer-based restorative materials. Overall, the subject device is substantially equivalent to the Predicate device.