Nexcomp

K181689 · Meta Biomed Co., Ltd. · EBF · Nov 15, 2018 · Dental

Device Facts

• Record ID: K181689
• Device Name: Nexcomp
• Applicant: Meta Biomed Co., Ltd.
• Product Code: EBF · Dental
• Decision Date: Nov 15, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Nexcomp is a light-cured, resin-based dental restorative material used by dentists for direct placement in anterior and posterior teeth. The material consists of a hybrid blend of ultra-fine filler and 40 nm silica particles in a resin matrix. It is applied to cavity preparations and cured using a light source (420-480nm wavelength). The device provides a radiopaque, esthetic restoration that mimics natural tooth structure. By restoring carious lesions or structural defects, it helps maintain tooth integrity and function. It is available in 19 shades corresponding to the Vita Shade Guide.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1, -5, -10, and -11. Physical property testing performed per ISO 4049 (flexural strength, water sorption, solubility), ISO 6507-1 (Vickers hardness), and ISO 3107 (compressive strength). Results confirm compliance with international standards.

Technological Characteristics

Light-cured resin-based composite. Composition: Bis-GMA, UDMA, Bis-EMA, TEGDMA, TMPTMA, GDMA, Camphorquinone. Fillers: Barium glass (0.78 µm) and silica (16nm). Curing: 420-480nm wavelength, 1000-1200 mW/cm² intensity, 20-second duration. Radiopaque. Complies with ISO 4049 (Type 1, Class 2, Group 1), ISO 6507-1, and ISO 3107.

Indications for Use

Indicated for patients requiring restoration of carious lesions or structural tooth defects, including Class I-V restorations, core-buildup, splinting, diastema closure, direct veneers, and composite/porcelain repairs.

Regulatory Classification

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.

Predicate Devices

• Nexcomp (K080305)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

**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: [e-mail] Phone: [phone] Fax: [phone]

## 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

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.

#### 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: [e-mail] Phone: [phone] Fax: [phone]

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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 structural<br>defects in teeth. It is indicated for Class I, II, III, IV, and V<br>restorations, core-buildup to replace missing tooth structure, for<br>splinting and for diastema closure, direct veneers, composite<br>and porcelain repairs. | Nexcomp is intended to restore carious lesions or structural<br>defects in teeth. It is indicated for Class I, II, III, IV, and V<br>restorations, core-buildup to replace missing tooth structure, for<br>splinting and for diastema closure, direct veneers, composite<br>and porcelain repairs. |
| Principle of operation | - | Nexcomp is visual light curing polymer based restorative<br>product as suitable for restorations involving occlusal surfaces<br>classed by Type 1, Class 2, Group 1 on ISO 4049. | Nexcomp is visual light curing polymer based restorative<br>product as suitable for restorations involving occlusal surfaces<br>classed by Type 1, Class 2, Group 1 on ISO 4049. |
| General Composition | - | - Bis-Gma[Bispenol A Glycerolate<br>(1glycerol/ Phenol)dimethacrylate]<br>- UDMA[Diurethane dimethacrylate]<br>- Bis-Ema [Bisphenol A ethoxylate dimethacrylate]<br>- TEGDMA[Tri(ethylene glycol)dimethacrylate]<br>- TMPTMA[Trimethylol propane trimethacrylate]<br>- GDMA[Glycerol dimethacrylate]<br>- Camphorquinone | - Bis-Gma[Bispenol A Glycerolate<br>(1glycerol/ Phenol)dimethacrylate]<br>- UDMA[Diurethane dimethacrylate]<br>- Bis-Ema [Bisphenol A ethoxylate dimethacrylate]<br>- TEGDMA[Tri(ethylene glycol)dimethacrylate]<br>- TMPTMA[Trimethylol propane trimethacrylate]<br>- GDMA[Glycerol dimethacrylate]<br>- Camphorquinone |
| Sensitivity of ambient<br>light | Remain<br>physically<br>homogeneous | Physical homogeneity | Physical homogeneity |
| Compressive strength | Should be more<br>than 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 size<br>distribution | - | Barium glass : 0.78 µm<br>Silica :16nm | - |
| Surface hardness<br>(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.<br>(Working time test is applied for self-cured resin.) | |
| Curing time | - | 20sec | - |
| Setting time | | This device is a light curing type product.<br>(Setting time test is applied for self-cured resin.) | |
| Shade and color<br>stability | - | 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.