EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Filler size ranges from 16nm to 1.2 um. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radioopaque.

AI/ML Overview

The provided text is a 510(k) summary for a dental device called EsCom250. This type of document is a submission to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

The information you are requesting pertains to the performance evaluation of a device, particularly an AI/ML-based medical device. The provided document, however, describes a dental restorative material (a tooth shade resin material), not an AI/ML-based device.

Therefore, the concepts of acceptance criteria for AI performance (like accuracy, sensitivity, specificity), sample size for test/training sets, data provenance, expert ground truth adjudication for AI, MRMC studies, standalone AI performance, etc., are not applicable to this document.

This document focuses on the physical, chemical, and biological properties of the dental resin material as compared to a predicate device, using established standards for dental materials (e.g., ISO 4049, ISO 10993 for biocompatibility).

Key points from the document regarding "acceptance criteria" and "proof" for this specific device:

Acceptance Criteria/Performance Evaluation: The primary method for proving the device meets acceptance criteria is through bench testing and biocompatibility testing.
- Bench Testing: The device was tested according to ISO 4049:2019, Dentistry Polymer-based restorative materials. This standard specifies requirements and test methods for polymer-based dental restorative materials.
- Biocompatibility Testing: The device was tested according to various parts of ISO 10993 (Biological evaluation of medical devices) and ISO 7405 (Dentistry Evaluation of biocompatibility of medical devices used in dentistry). These standards assess the biological safety of medical devices.

Reported Device Performance (Table): The table on page 6 of the document provides a direct comparison of several mechanical properties between the subject device (EsCom250) and the predicate device (Filtek Z250 Universal Restorative). These are the "reported device performance" metrics for this type of product.

Metric	Acceptance Criteria (Predicate)	EsCom250 Performance
Mechanical Properties
Depth of cure (mm) - A3	2.80	2.27
Depth of cure (mm) - AO3	(Not specified for predicate)	1.53
Flexural strength (Mpa)	157.96	127.62
Water sorption (µg/mm³)	16.00	11.52
Solubility (µg/mm³)	0.0	0.0
Radio-opacity (mmAl) - A3	2.9	3.6
Radio-opacity (mmAl) - AO3	(Not specified for predicate)	3.1
Knoop hardness (kgf/mm²)	77.9	55.4
Compressive strength (MPa)	346	334
Elastic modulus (GPa)	4.04	3.03
Other Properties
Standard Conformed	ISO 4049	≥ISO 4049
Biocompatibility	Yes	Yes
Sensitivity to light	Remained physically homogeneous	Remained physically homogeneous

Note on "Acceptance Criteria" for this device type: For equivalence, the EsCom250 values generally need to be comparable to or better than the predicate, or at least meet the minimum requirements of the conformed standard (ISO 4049). The document explicitly states that "the performance results of the subject device and predicate device are not the same, but both products meet the requirements of ISO 4049." This implies that meeting the ISO 4049 standard itself is a key acceptance criterion for these properties, rather than strict numerical matching of the predicate.

Given the nature of the device (dental resin) and the provided document, the other requested points are not applicable:

Sample size for test set and data provenance: Not applicable. These tests are laboratory/bench tests on material samples, not data sets from patients.
Number of experts used to establish ground truth: Not applicable. Ground truth for these physical/chemical properties is established by standardized laboratory measurements, not human expert consensus.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not applicable. This is for AI/human reader performance.
Standalone (algorithm only) performance: Not applicable. There is no algorithm.
Type of ground truth used: For physical properties, it's objective measurements based on ISO standards. For biocompatibility, it's biological response testing per ISO standards.
Sample size for training set: Not applicable. This material is not an AI/ML model.
How ground truth for training set was established: Not applicable. There is no training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

July 24, 2023

Spident Co., Ltd. Eunok Choi RA Manager 203 & 312, Korea Industrial Complex, 722 Gojan-Dong. Namdong-Gu Incheon, Incheon 405-821 Korea. South

Re: K231523

Trade/Device Name: EsCom250 Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: May 23, 2023 Received: May 26, 2023

Dear Eunok Choi:

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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).

Sincerely,

Bobak Shirmohamma di -S

For Michael E. Adjodha, M. ChE., 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)

K231523

Device Name EsCom250

Indications for Use (Describe)

· Direct anterior and posterior restorations
· Restoration of fractured (broken) teeth due to trauma
Restoration of deciduous teeth
· Direct restorative for diastema closure

Type of Use (Select one or both, as applicable)
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|X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Spident. The logo is green and features the word "SPIDENT" in a bold, sans-serif font. The letters are enclosed in a square shape, with the top and right sides of the square missing. The logo is simple and modern.

SPIDENT CO., LTD.

203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu, Incheon, Korea 405-821 Tel : +82-32-821-0071 Fax : + 82-32-821-0074

Section 5. 510(k) Summary K231523

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92(c).

Date: June 21, 2023

1. Company and Correspondent making the submission:

Company Name : SPIDENT CO., LTD. Address : 203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu, Incheon, Korea 405-821 Tel : +82-32-821-0071 Fax : + 82-32-821-0074 Company Contact : Eunok Choi/RA Manager

2. Device Name and Classification

Proprietary Name : EsCom250 Common name : Dental light-cured composite resin Classification name : Tooth shade resin material [CFR 872.3690] Product code : EBF Class : II

3. Predicate Devices (Legally Marketed Devices)

The predicate devices for EsCom250 is :

· Filtek Z250 Universal Restorative, 3M ESPE Dental Products, K183476

4. Description:

EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Filler size ranges from 16nm to 1.2 m. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radioopaque.

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Image /page/4/Picture/0 description: The image shows a logo for SPIDENT. The logo is green and features the word "SPIDENT" in a sans-serif font. The letters are all capitalized and are a light shade of green. The word is enclosed in a square with rounded corners, and the bottom line of the square extends horizontally under the entire word.

5. Indications for Use

Direct anterior and posterior restorations .
. Restoration of fractured (broken) teeth due to trauma
. Restoration of deciduous teeth
. Direct restorative for diastema closure

6. Performance Testing - Bench

The performance test was conducted to prove the substantially equivalence of the subject device, and the standards applied to the performance test are as follows.

· ISO 4049:2019, Dentistry Polymer-based restorative materials

7. Biocompatibility

Biocompatibility tests and biological safety evaluation were performed and the results proved that the subject device is at least as biocompatible and biologically safe as the predicate device.

The standards applied are as follows.

· ISO 10993-1:2018, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
· ISO 10993-3:2014, Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
· ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
· ISO 10993-6:2016, Biological evaluation of medical devices Part 6: Tests for local effects after implantation
· ISO 10993-10:2010, Biological evaluation of medical devices. Tests for irritation and skin sensitization
· ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity
· ISO 10993-18:2020, Biological evaluation of medical devices Part 18: Chemical characterization of medical device materials within a risk management process
· ISO 7405:2018, Dentistry Evaluation of biocompatibility of medical devices used in dentistry

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Image /page/5/Picture/0 description: The image features the word "SPIDENT" in a bold, sans-serif font, rendered in a vibrant green color. The word is partially enclosed within a square bracket-like shape, also in green, which frames the beginning and end of the word. The overall design is clean and modern, with a focus on the brand name.

SPIDENT CO., LTD. 203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu, Incheon, Korea 405-821 Tel : +82-32-821-0071 Fax : + 82-32-821-0074

Product Name	EsCom250	Filtek Z250 Universal Restorative
510(k)	N/A	K183476
Manufacturer	SPIDENT CO., LTD.	3M ESPE Dental Products
Productdescription	EsCom250 is the polymer-baseddental restorative material. It can belight-cured intra orally for anteriorand posterior restoration includingocclusal surface. Filler size rangesfrom 16nm to 1.2um. Various shadesof A1, A2, A3, A3.5, A4, B1, B2,C2, D2, G1, AO2, AO3 and TW foresthetic restoration are provided. Allshades of EsCom250 are radio-opaque.	3M™ ESPE™ Filtek™ Z250Universal Restorative material is avisible-light activated, radiopaque,restorative composite. It is designedfor use in both anterior and posteriorrestorations. The filler in Filtek Z250restorative is zirconia/silica. Theinorganic filler loading is 60% byvolume (without silane treatment)with a particle size range of 0.01 to3.5 µm. Filtek Z250 restorativecontains BIS-GMA, UDMA, andBIS-EMA resins. A dental adhesive,such as manufactured by 3M ESPE,is used to permanently bond therestoration to the tooth structure. Therestorative is available in a variety ofshades. It is packaged in traditionalsyringes and single-dose capsules.
Chemicalcomposition ofResin	Methacrylate monomerFillerPhoto initiatorPhoto inhibitorPhoto stabilizerpigment	Methacrylate monomerFillerEtc.
Indications foruse	• Direct anterior and posteriorrestorations• Restoration of fractured (broken)teeth due to trauma• Restoration of deciduous teeth• Direct restorative for diastemaclosure	• Direct anterior and posteriorrestorations• Core buildups• Splinting• Indirect restorations includinginlays, onlays and veneers
Principle ofoperation	Light cured	Light cured
MechanicalProperties• Depth of cure(mm)	2.27 (A3 shade)1.53 (AO3 shade)	2.80
Flexural strength(Mpa)	127.62	157.96
Water sorption(µg/mm³)	11.52	16.00
Solubility(µg/mm³)	0.0	0.0
Sensitivity tolight	After ambient light expose, thematerial remained physicallyhomogeneous	After ambient light expose, thematerial remained physicallyhomogeneous
Radio-opacity(mmAl)	3.6 (A3)3.1 (AO3)	2.9
Knoop hardness(kgf/mm²)	55.4	77.9
Compressivestrength (MPa)	334	346
Elastic modulus(GPa)	3.03	4.04
Standardconformed	≥ISO 4049	ISO 4049
Biocompatibility	Yes	Yes
Light CuringTime	20 Seconds (1200 mW/cm² light)	A1, A2, A3, A3.5, A4, B1, B2, B3,C2, D3, I : 20 sec.UD : 30 sec.(minimum intensity of 400 mW/cm²)
Intensity forcuring	1200mW/cm²	400mW/cm²
Wavelength forcuring	440~490nm	400~500 nm
Filler particle sizedistribution	16nm~1.2µm	10nm~3.5µm
Application Area	Tooth	Tooth
Target Population	Dental patient	Dental patient
IntendedOperator	Dentist who has experience of dentallight-cured composite restoration	Dentist
Storage condition	2-27°C	No higher than 27°C
Shade	A1, A2, A3, A3.5, A4, B1, B2, C2,D2, G1, AO2, AO3, TW	A1, A2, A3, A3.5, A4, B1, B2, B3,C2, D3, I, UD

8. Substantial Equivalence Discussion

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Image /page/6/Picture/0 description: The image shows the logo for SPIDENT. The logo is green and features the word "SPIDENT" in a sans-serif font. The letters are enclosed in a square shape with rounded corners. The logo is simple and modern.

SPIDENT CO., LTD.

203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu, Incheon, Korea 405-821 Tel : +82-32-821-0071 Fax : + 82-32-821-0074

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Image /page/7/Picture/0 description: The image shows a logo with the word "spIDENT" in green. The letters "spID" are on the left side of the logo, and the letters "ENT" are on the right side. The letters are inside of a green box.

9. Similarities and Differences with Marketed Devices:

The subject device, EsCom250 and the predicate device, Filtek Z250 Universal Restorative were compared as above. Both products have the similar product description as a dental light-cured composite resin.

In case of composition, subject device and predicate device contain slightly different raw materials, but the subject device and predicate device both mainly composed of monomers and fillers. In addition, specific information on initiator, inhibitor, and pigment is not known, but considering that the predicate device is a dental light-cured composite resin which has various shades, it can be expected that raw materials such as initiator, inhibitor, and pigment were used in the predicate device like the subject device. Therefore, even if there is a slight difference in the raw materials used, it can be expected that there will be no significant difference in performance and safety from the Filtek Z250 Universal Restorative. Also, the results of the Performance test according to ISO 4049 and the Biocompatibility test according to ISO 10993-1 confirmed that the subject device had no problems related to performance and biological safety.

The indications for use of the subject device are as follows.

1. Direct anterior and posterior restorations
1. Restoration of fractured (broken) teeth due to trauma
1. Restoration of deciduous teeth
1. Direct restorative for diastema closure

The indications for use above are not perfectly same with the indications for use of predicate device, but the indications for use of subject device are included in the indications of predicate device.

Principle Operation, Biocompatibility, Application Area and Target Population of subject device and predicate device are the same. The performance results of the subject device and predicate device are not the same, but both products meet the requirements of ISO 4049. Also, both products have similar intended operator.

Light curing time, Intensity for curing, Wavelength for curing, storage condition, and shade between the subject device and predicate device are slightly different, but these differences would not raise any questions of safety and effectiveness.

Therefore, EsCom250 is substantially equivalent with predicate device. Filtek Z250 Universal Restorative, and at least as safe and effective as the predicate device.

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Image /page/8/Picture/0 description: The image shows the logo for SPIDENT. The logo is green and features the word "SPIDENT" in a sans-serif font. The letters are enclosed in a square shape, with the top and bottom lines of the square extending beyond the letters. The logo is simple and modern.

SPIDENT CO., LTD. 203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu, Incheon, Korea 405-821 Tel : +82-32-821-0071 Fax : + 82-32-821-0074

10. Conclusion

Based on a comparison of subject device, EsCom250 (SPIDENT CO., LTD.) and predicate device, Filtek Z250 Universal Restorative (3M ESPE Dental Products), it is confirmed that the subject device is substantially equivalent to 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.