Nexcomp is intended to restore carious lesions or structural defects in teeth. It is indicated for Class I, III, IV, and V restorations, core-buildup to replace missing tooth structure, for splinting and for diastema closure, direct veneers, composite and porcelain repairs.

Device Description

Nexcomp is a light-cured, esthetic, resin-based dental restorative designed for direct placement in both anterior and posterior restorations. The material is radiopaque and indicated for all types of cavity preparations. The hybrid blend has an ultra-fine filler and 40 nm silica particles. Nexcomp will be marketed in 19 shades which corresponded with the Vita Shade Guide.

AI/ML Overview

The provided text describes the 510(k) premarket notification for a dental restorative material called Nexcomp. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that an AI/device meets specific acceptance criteria for diagnostic performance.

Therefore, I cannot extract the detailed information requested regarding AI/device performance, reader studies, ground truth establishment, or sample sizes for training/test sets as these concepts are not applicable to the provided document. The document concerns a physical dental material, not an AI or diagnostic device.

However, I can extract the acceptance criteria and performance data for the physical properties of the Nexcomp dental material and present it in a table, as well as information about the testing performed.

Acceptance Criteria and Device Performance (for Physical Properties of Dental Material)

The document primarily focuses on demonstrating that the new Nexcomp device has similar physical properties to its predicate device, and that these properties meet relevant ISO standards for dental materials.

1. Table of Acceptance Criteria and Reported Device Performance

Property	Acceptance Criteria (ISO Standards/Predicate Similarity)	Reported Device Performance (Subject Device)	Reported Predicate Device Performance
Material Properties
Compressive strength	Should be more than 5MPa.	Average 232.76 MPa	Average 288.68 MPa
Flexural strength	> 80 MPa	Average 87 MPa	91.82 MPa
Depth of cure	> 1.0 mm	2.88 mm	4.96 mm
Surface hardness (Vickers hardness)	Based on ISO 6507-1:2005 (no specific numerical criterion stated in table, but performance is compared)	Average 56 KHN	Average 39.36 KHN
Radio-opacity	> 1mm	More than 1mm	More than 1mm
Water sorption	< 40 µg/mm³	2.97 µg/mm³	13.78 µg/mm³
Solubility	< 7.5 µg/mm³	0.0 µg/mm³	0.23 µg/mm³
Sensitivity of ambient light	Physical homogeneity	Physical homogeneity	Physical homogeneity
Shade and color stability	Consistency	Consistency	Consistency
Shelf Life	3 years (equivalent to predicate)	3 years	3 years
Curing/Working Properties
Intensity for curing	Not specified as a criterion to meet, but stated	1000-1200 mV/cm²	- (Not reported for predicate)
Wavelength for curing	Not specified as a criterion to meet, but stated	420-480nm	- (Not reported for predicate)
Curing time	Not specified as a criterion to meet, but stated	20sec	- (Not reported for predicate)
Working time	Applies to self-cured resin. Light-cured for this device.	This device is a light curing type product.	- (Not reported for predicate)
Setting time	Applies to self-cured resin. Light-cured for this device.	This device is a light curing type product.	- (Not reported for predicate)
Other Filler Properties	Not specified as a direct criterion, but stated	Barium glass : 0.78 µm, Silica :16nm	- (Not reported for predicate)
Release profile	Not specified as a criterion, but stated	This device did not contain fluoride or nitrate ions.	- (Not reported for predicate)

Note: The document states that differences in depth of cure, surface hardness, and water sorption between the subject and predicate devices are acceptable because "the test results are within the range of the criteria of ISO standards such as ISO 4049 and ISO 6507 this difference does not affect the substantial equivalence."

Regarding the other points requested (which are generally for AI/Diagnostic devices):

2. Sample sizes used for the test set and the data provenance: Not applicable. This is not a study on diagnostic performance or an AI device. The "test set" here refers to lab samples of the material for physical property testing. No geographical data provenance is specified for these lab tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as in medical diagnosis is not relevant here. The "ground truth" for material properties is established by standardized laboratory testing according to ISO standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a human-in-the-loop diagnostic study. Lab tests follow specific protocols.

5. 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 is not an AI or diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the physical properties of the dental material is established through standardized laboratory testing methods following international standards (ISO 4049, ISO 6507-1, ISO 3107) and biocompatibility testing (ISO 10993 series).

8. The sample size for the training set: Not applicable. There is no "training set" as this is not a machine learning model.

9. How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a recognizable symbol of the agency's role in regulating and overseeing food and drug products in the United States.

Meta Biomed Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620

Re: K181689

Trade/Device Name: Nexcomp Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: October 12, 2018 Received: October 17, 2018

Dear April Lee:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

November 15, 2018

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Marv S. -Mary S. Runner -S3 Runner -S3 12:44:18 -05'00'

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K181689

Device Name Nexcomp

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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510(k) Summary

Submitter

META BIOMED CO., LTD. Suk Song Oh 270. Osongsaengmyeong 1-ro. Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Korea Email: ef1459@metabiogw.bizmeka.com Phone: +82-43-230-8841 Fax: +82-43-217-1983

Device Information

● Trade Name: Nexcomp

Classification Name: Tooth Shade Resin Material ●
. Product Code: EBF
Panel: Dental
Regulation Number: 21 CFR 872.3690
Device Class: Class II
Date prepared: 11/08/2018

Predicate Devices:

The subject device is substantially equivalent to the following predicate devices:

K080305, Nexcomp manufactured by Meta Biomed Co., Ltd. .

General Description

Indication for Use

Nexcomp is intended to restore carious lesions or structural defects in teeth. It is indicated for Class I, II, III, IV, and V restorations, core-buildup to replace missing tooth structure, for splinting and for diastema closure, direct veneers, composite and porcelain repairs.

Official Correspondent

Withus Group Inc April Lee 106 Superior. Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122

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Comparison of technological Characteristics with Predicate Devices:

	Specification	Subject Device	Primary Predicate Device
Manufacturer	-	META BIOMED CO., LTD.	META BIOMED CO., LTD.
Device Name	-	Nexcomp	Nexcomp
510(k) Number	-	K181689	K080305
Classification Name	-	Tooth Shade Resin Material	Tooth Shade Resin Material
Product Code	-	EBF	EBF
Regulation Number	-	21 CFR 872.3690	21 CFR 872.3690
Indications for Use	-	Nexcomp is intended to restore carious lesions or structuraldefects in teeth. It is indicated for Class I, II, III, IV, and Vrestorations, core-buildup to replace missing tooth structure, forsplinting and for diastema closure, direct veneers, compositeand porcelain repairs.	Nexcomp is intended to restore carious lesions or structuraldefects in teeth. It is indicated for Class I, II, III, IV, and Vrestorations, core-buildup to replace missing tooth structure, forsplinting and for diastema closure, direct veneers, compositeand porcelain repairs.
Principle of operation	-	Nexcomp is visual light curing polymer based restorativeproduct as suitable for restorations involving occlusal surfacesclassed by Type 1, Class 2, Group 1 on ISO 4049.	Nexcomp is visual light curing polymer based restorativeproduct as suitable for restorations involving occlusal surfacesclassed by Type 1, Class 2, Group 1 on ISO 4049.
General Composition	-	- Bis-Gma[Bispenol A Glycerolate(1glycerol/ Phenol)dimethacrylate]- UDMA[Diurethane dimethacrylate]- Bis-Ema [Bisphenol A ethoxylate dimethacrylate]- TEGDMA[Tri(ethylene glycol)dimethacrylate]- TMPTMA[Trimethylol propane trimethacrylate]- GDMA[Glycerol dimethacrylate]- Camphorquinone	- Bis-Gma[Bispenol A Glycerolate(1glycerol/ Phenol)dimethacrylate]- UDMA[Diurethane dimethacrylate]- Bis-Ema [Bisphenol A ethoxylate dimethacrylate]- TEGDMA[Tri(ethylene glycol)dimethacrylate]- TMPTMA[Trimethylol propane trimethacrylate]- GDMA[Glycerol dimethacrylate]- Camphorquinone
Sensitivity of ambientlight	Remainphysicallyhomogeneous	Physical homogeneity	Physical homogeneity
Compressive strength	Should be morethan 5MPa.	Average 232.76 MPa	Average 288.68MPa
Flexural strength	> 80 MPa	Average 87MPa	91.82MPa
Intensity for curing	-	1000-1200 mV/cm²	-
Wavelength for curing	-	420-480nm	-
Depth of cure	> 1.0 mm	2.88mm	4.96 mm
Filler particle sizedistribution	-	Barium glass : 0.78 µmSilica :16nm	-
Surface hardness(Vickers hardness)	-	Average 56KHN	Average 39.36KHN
Radio-opacity	> 1mm	More than 1mm	More than 1mm
Water sorption	< 40 $\mu g/mm^3$	2.97 $\mu g/mm^3$	13.78 $\mu g/mm^3$
Solubility	< 7.5 $\mu g/mm^3$	0.0 $\mu g/mm^3$	0.23 $\mu g/mm^3$
Release profile		This device did not contain fluoride or nitrate ions.
Working time		This device is a light curing type product.(Working time test is applied for self-cured resin.)
Curing time	-	20sec	-
Setting time		This device is a light curing type product.(Setting time test is applied for self-cured resin.)
Shade and colorstability	-	Consistency	Consistency
Shelf Life	-	3 years	3 years

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Both subject and predicate devices have indications for use, principle of operation, Sensitivity of ambient light, radio opacity and shelf life. The physical properties of subject and predicate devices such as compressive strength, flexural strength, and solubility are all similar.

As depicted above, the values for the depth of cure, surface hardness and water sorption between the subject device and predicate device are different but the test results are within the range of the criteria of ISO standards such as ISO 4049 and ISO 6507 this difference does not affect the substantial equivalence.

Non-clinical Testing

The subject device was tested to the following standards:

Biocompatibility Testing according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993--10:2010, and ISO 10993-11:2006.
Physical properties testing and shelf life test according to ISO 4049:2009 -
-Surface hardness test according to ISO 6507-1:2005
Compressive Strength Test according to ISO 3107:2011 -

The data analysed from the biocompatibility evaluation of the subject device, and the results of the biocompatibility tests according to ISO 10993 substantiate that the Nexcomp is substantially equivalent to the predicate device. The subject device is different from the predicate devices in that it contains the same key biocompatible ingredients, but in different proportions. The biocompatibility test report supports this difference and it does not affect the substantial equivalence.

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Conclusion

The Subject Device, Nexcomp has been compared with its predicate, Nexcomp with regard to indications, performance data and chemical composition. The comparison shows that Nexcomp 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.