(59 days)
Not Found
No
The device description and performance studies focus on the material properties and biocompatibility of a dental restorative material, with no mention of AI or ML.
Yes
The device is a restorative material used to repair fractured or damaged teeth, which is a therapeutic intervention.
No
The device description and intended use clearly state that it is a restorative material used for filling cavities and repairing teeth, not for diagnosing conditions.
No
The device description clearly states it is a "polymer-based dental restorative material," which is a physical substance, not software. The performance studies also focus on material properties and biocompatibility, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a material used for direct restoration of teeth, addressing issues like cavities, fractures, and diastema. This is a therapeutic and restorative application, not a diagnostic one.
- Device Description: The description details a polymer-based dental restorative material that is light-cured and used intraorally. This aligns with materials used to physically repair or replace tooth structure.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
- Anatomical Site: The anatomical site is the tooth, which is where the material is applied for restoration.
- Performance Studies: The performance studies focus on proving substantial equivalence to a predicate device (Filtek Z250 Universal Restorative) and biocompatibility, which are relevant for a restorative material, not a diagnostic one.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to physically restore damaged tooth structure.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentist who has experience of dental light-cured composite restoration
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)
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
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Depth of cure (mm): 2.27 (A3 shade), 1.53 (AO3 shade)
- Flexural strength (Mpa): 127.62
- Water sorption (µg/mm³): 11.52
- Solubility (µg/mm³): 0.0
- Radio-opacity (mmAl): 3.6 (A3), 3.1 (AO3)
- Knoop hardness (kgf/mm²): 55.4
- Compressive strength (MPa): 334
- Elastic modulus (GPa): 3.03
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.
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
§ 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.
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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
1
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)
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) | |
|---|---|
| ------------------------------------------------- | -- |
|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 |
| Product | ||
| 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 1.2um. 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 radio- | ||
| opaque. | 3M™ ESPE™ Filtek™ Z250 | |
| Universal Restorative material is a | ||
| visible-light activated, radiopaque, | ||
| restorative composite. It is designed | ||
| for use in both anterior and posterior | ||
| restorations. The filler in Filtek Z250 | ||
| restorative is zirconia/silica. The | ||
| inorganic filler loading is 60% by | ||
| volume (without silane treatment) | ||
| with a particle size range of 0.01 to | ||
| 3.5 µm. Filtek Z250 restorative | ||
| contains BIS-GMA, UDMA, and | ||
| BIS-EMA resins. A dental adhesive, | ||
| such as manufactured by 3M ESPE, | ||
| is used to permanently bond the | ||
| restoration to the tooth structure. The | ||
| restorative is available in a variety of | ||
| shades. It is packaged in traditional | ||
| syringes and single-dose capsules. | ||
| Chemical | ||
| composition of | ||
| Resin | Methacrylate monomer | |
| Filler | ||
| Photo initiator | ||
| Photo inhibitor | ||
| Photo stabilizer | ||
| pigment | Methacrylate monomer | |
| Filler | ||
| Etc. | ||
| 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 | • Direct anterior and posterior | |
| restorations | ||
| • Core buildups | ||
| • Splinting | ||
| • Indirect restorations including | ||
| inlays, onlays and veneers | ||
| Principle of | ||
| operation | Light cured | Light cured |
| Mechanical | ||
| Properties | ||
| • 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 to | ||
| light | After ambient light expose, the | |
| material remained physically | ||
| homogeneous | After ambient light expose, the | |
| material remained physically | ||
| homogeneous | ||
| Radio-opacity | ||
| (mmAl) | 3.6 (A3) | |
| 3.1 (AO3) | 2.9 | |
| Knoop hardness | ||
| (kgf/mm²) | 55.4 | 77.9 |
| Compressive | ||
| strength (MPa) | 334 | 346 |
| Elastic modulus | ||
| (GPa) | 3.03 | 4.04 |
| Standard | ||
| conformed | ≥ISO 4049 | ISO 4049 |
| Biocompatibility | Yes | Yes |
| Light Curing | ||
| Time | 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 for | ||
| curing | 1200mW/cm² | 400mW/cm² |
| Wavelength for | ||
| curing | 440~490nm | 400~500 nm |
| Filler particle size | ||
| distribution | 16nm~1.2µm | 10nm~3.5µm |
| Application Area | Tooth | Tooth |
| Target Population | Dental patient | Dental patient |
| Intended | ||
| Operator | Dentist who has experience of dental | |
| light-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
7
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.
-
- Direct anterior and posterior restorations
-
- Restoration of fractured (broken) teeth due to trauma
-
- Restoration of deciduous teeth
-
- 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.