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.

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.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for a dental resin material named "C&B NFH Hybrid." It primarily focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against acceptance criteria in a clinical study involving experts or human readers with AI assistance.

Therefore, many of the requested details about acceptance criteria and a study proving device meets them are not applicable in this context, as this document pertains to a material's physical and chemical properties and biocompatibility for substantial equivalence, rather than an AI-powered diagnostic device or a device requiring a multi-reader, multi-case study.

However, I can extract the acceptance criteria and reported performance for the physical properties of the dental resin, which are relevant to its substantial equivalence.

Acceptance Criteria and Reported Device Performance (Physical Properties of Dental Resin)

Acceptance Criteria (Standard)	Reported Device Performance (C&B NFH Hybrid)
Flexural Strength (≥50 MPa; ISO 10477)	Avg. 114.32 MPa
Flexural Strength (≥100 MPa; ISO 4049)	Avg. 114.32 MPa
Water sorption (≤40 µg/mm³)	Avg. 31.32 µg/mm³
Solubility (≤7.5 µg/mm³)	Avg. 5.59 µg/mm³

Study Information (Based on the document provided):

Sample size used for the test set and the data provenance: Not explicitly stated with specific numbers of samples for each test (e.g., how many specimens were tested for flexural strength). The data provenance is from non-clinical performance testing conducted by the manufacturer, ARUM DENTISTRY Co., Ltd., likely in a laboratory setting. This is not patient-specific or clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For physical property testing of a material, "ground truth" is typically established by standardized testing methods and measurements, not by expert interpretation in the medical sense.
Adjudication method for the test set: Not applicable. Standardized laboratory testing methods do not involve adjudication in the way clinical studies with human observers do.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a dental material, not an AI-powered diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a dental material, not an algorithm.
The type of ground truth used: Standardized laboratory measurements according to ISO 10477:2020 and ISO 4049:2013 for physical properties (flexural strength, water sorption, solubility). For biocompatibility, compliance was shown with ISO 7405, ISO 10993-1, -5, -10, -11, -12, and -23.
The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires training data.
How the ground truth for the training set was established: Not applicable.

Summary of the "Study" (Non-Clinical Performance Data) from the document:

The device did not undergo a "study" in the clinical sense with human readers or AI. Instead, the manufacturer provided Non-Clinical Performance Data to support the substantial equivalence determination for the "C&B NFH Hybrid" dental resin.

The data presented focuses on:

Physical Property Testing: The device was tested for flexural strength, water sorption, and solubility. The reported values demonstrate that the device meets or exceeds the requirements set by the international standards ISO 10477:2020 ("Dentistry - Polymer-based crown and veneering materials") and ISO 4049:2013 ("Dentistry - Polymer-based restorative materials").
Biocompatibility: The C&B NFH Hybrid material (Dimethacrylate based resins) was shown to be compliant with a series of ISO 10993 and ISO 7405 standards for biocompatibility (e.g., cytotoxicity, irritation, sensitization, systemic toxicity).
Shelf-Life: Accelerated aging tests in accordance with ASTM F1980 validated a 2-year shelf-life.

The purpose of these tests was to demonstrate that the C&B NFH Hybrid has similar safety and effectiveness characteristics to its predicate device (K202846, TERA HARZ by Graphy Inc.) and meets established performance standards for dental materials. The conclusion is that the subject device is substantially equivalent to the predicate device.

Summary

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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).

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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).

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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)

K232559

Device Name C&B NFH Hybrid

Indications for Use (Describe)

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

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

1. Digital file
- File format: STL file
- File size should be upload-able in the 3D printer operation software
1. 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
1. Printing parameters

Printer Model	Layer Thickness(micron)	Recommendedorientation angle(degree)	Support pointsize(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 indirectrestorative for both anterior and posteriorrestorations, including occlusal surfaces. The C&BNFH Hybrid material is used for fabricatingtemporary or permanent restorations such ascrowns and bridges, inlays, onlays, veneers andfull crown restorations. Fabrication of C&B NFHHybrid requires a computer-aided andManufacturing (CAD/CAM) system that includesthe following: scanner, design software, additiveprinter, and post-cure unit.	TERA HARZ is indicated as an indirect restorativefor both anterior and posterior restorations,including occlusal surfaces. The TERA HARZmaterial is used for fabricating temporary orpermanent restorations such as crowns andbridges, inlays, onlays, veneers and full crownrestorations. Fabrication of TERA HARZ requiresa computer-aided and Manufacturing (CAD/CAM)system that includes the following: scanner,design software, additive printer, and post-cureunit.
ManufacturingTechnology	3D liquid (light-cured) print resin for dentalCAD/CAM	3D liquid (light-cured) print resin for dentalCAD/CAM
Chemical composition	Trimethylolpropane TrimethacrylateDiphenyl phosphine OxideUrethane DimethacrylateTitanium dioxidePigments	Polyurethane Resin;Methacrylate;Dimethacrylate;Phosphine oxide;Butylated HydroxytoluenePigments

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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 EquivalentDiscussion	1. SimilaritiesThe subject and predicate or reference devices are very similarities in they are all polymer resins. Thespecifications of flexural strength, water sorption and solubility are in the same range. This minor variancedoes not introduce additional safety or efficacy concerns. Both devices meet requirements from ISO10477:2020, Dentistry - Polymer-based crown and veneering materials. and ISO 4049:2013,Dentistry - Polymer-based restorative materials2. DifferencesCompared with the primary predicate, the slight differences in chemical composition do not change theintended use of the subject, predicate and reference devices to be used in the fabrication of dentalprostheses. 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.

Regulation Number and Section

§ 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.