Nexcomp

• K Number: K181689
• Device Name: Nexcomp
• Manufacturer: Meta Biomed Co., Ltd.
• Date Cleared: 2018-11-15 ( 142 days)
• Product Code: EBF
• Regulation Number: 872.3690

Intended Use

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.

Predicate Devices

K080305

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a dental restorative material and its physical properties, with no mention of AI or ML capabilities.

Therapeutic

No
The device is a dental restorative material used to fill cavities and restore tooth structure, which is a reparative function, not a therapeutic one aiming to treat a disease or disorder.

Diagnostic

No
The device, Nexcomp, is a restorative material used to repair and restore damaged teeth. Its intended use is to treat existing conditions (carious lesions or structural defects) rather than to diagnose them.

SaMD (Software as a Medical Device)

No

The device description clearly indicates it is a physical material (light-cured, esthetic, resin-based dental restorative) used for direct placement in teeth, not a software application.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to restore carious lesions or structural defects in teeth. This is a direct treatment/restoration of a physical issue within the body.
• Device Description: The device is a light-cured, resin-based dental restorative material. This is a material used for physical repair.
• Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze samples from the body (like blood, urine, or tissue), or provide information about a patient's health status based on in vitro testing.
• Testing: The testing described focuses on biocompatibility and physical properties of the material itself, not on its ability to perform a diagnostic test.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

EBF

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

teeth

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical Testing:

• 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 -

Key results: Physical properties of subject and predicate devices such as compressive strength, flexural strength, and solubility are all similar. 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. The biocompatibility test report supports this difference and it does not affect the substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Compressive strength: Average 232.76 MPa
Flexural strength: Average 87MPa
Depth of cure: 2.88mm
Surface hardness (Vickers hardness): Average 56KHN
Radio-opacity: More than 1mm
Water sorption: 2.97 ug/mm^3
Solubility: 0.0 ug/mm^3
Shelf Life: 3 years

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.

K080305

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.

Not Found

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

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.

Summary

0

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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
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.	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.
Principle of operation	-	Nexcomp is visual light curing polymer based restorative
product as suitable for restorations involving occlusal surfaces
classed by Type 1, Class 2, Group 1 on ISO 4049.	Nexcomp is visual light curing polymer based restorative
product as suitable for restorations involving occlusal surfaces
classed 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 ambient
  light | Remain
  physically
  homogeneous | Physical homogeneity | Physical homogeneity |
  | Compressive strength | Should be more
  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
  distribution | - | Barium glass : 0.78 µm
  Silica :16nm | - |
  | Surface hardness
  (Vickers hardness) | - | Average 56KHN | Average 39.36KHN |
  | Radio-opacity | > 1mm | More than 1mm | More than 1mm |
  | Water sorption |