(357 days)
Final cementation of all-ceramic, metal-based inlays, onlays, posts, crown and bridge
EsCem is a dual-cured resin cement that can be self-etched and self-adhesive. It is classified as type 2 and class 3 according to ISO 4049. It is easy to handle with 'one step' system that does not need pre-treatment process, and it is easy to remove excess cement, so it is possible to perform quick operation. It is also easy to identify because it has a radio-opacity(1.2mm Al). And it offers various shades for aesthetics and color stable.
This document describes the performance testing for a dental cement called EsCem, manufactured by SPIDENT Co., Ltd. The purpose of the testing is to demonstrate the substantial equivalence of EsCem to a legally marketed predicate device, G-CEM LinkAce (K120243), manufactured by GC America Inc.
1. Acceptance Criteria and Device Performance
The performance testing was conducted according to various sections of the ISO 4049:2019, Dentistry Polymer-based restorative materials standard. The table below lists the acceptance criteria and the reported device performance for EsCem. Since specific numerical results for EsCem are not provided in the document (only whether it met the requirement), the "Reported Device Performance" column reflects that it met the acceptance criteria. For comparison, the document states that both the subject device and the predicate device meet the requirements of ISO 4049.
| Performance | Test method | Acceptance Requirement | Reported Device Performance (EsCem) |
|---|---|---|---|
| Film thickness | ISO 4049:2019 - 7.5 Measurement of film thickness of luting materials | Shall be no greater than 50 μm. | Met requirement |
| Working time | ISO 4049:2019 - 7.7 Working time, Class 1 and Class 3 luting materials | During its formation there shall be no detectable change in its homogeneity. | Met requirement |
| Setting time | ISO 4049:2019 - 7.8 Setting time, Class 1 and Class 3 materials | Shall be no more than 10 min (600 sec). | Met requirement |
| Flexural strength | ISO 4049:2019 - 7.11 Flexural strength | Shall be equal to or greater than 50 MPa. | Met requirement |
| Water sorption | ISO 4049:2019 - 7.12 Water sorption and solubility | Shall be equal to or less than 40 µg/mm³. | Met requirement |
| Solubility | ISO 4049:2019 - 7.12 Water sorption and solubility | Shall be equal to or less than 7.5 µg/mm³. | Met requirement |
| Radio-opacity | ISO 4049:2019 - 7.14 Radio-opacity | Shall be equal to or greater than that of the same thickness of aluminum. | Met requirement (1.2mm Al stated) |
| Sensitivity to light | ISO 4049:2019 - 7.9 Sensitivity to light, Class 2 materials | The material shall remain physically homogeneous. | Met requirement |
| Color stability | ISO 4049:2019 - 7.13 Shade and colour stability after irradiation and water sorption | No more than a slight change in color shall be observed. | Met requirement |
2. Sample Size for Test Set and Data Provenance
The document does not specify the exact sample sizes used for each performance test (e.g., number of specimens for film thickness, flexural strength, etc.). The provenance of the data is retrospective bench testing, conducted by SPIDENT Co., Ltd. in South Korea.
3. Number of Experts and Qualifications for Ground Truth
This study is a bench performance testing for a dental cement, not an AI/ML medical device. Therefore, the concept of "ground truth established by experts" in the context of interpretation (e.g., radiological reads) does not apply. The ground truth for this device is based on established international consensus standards (ISO 4049:2019) for physical and chemical properties of dental materials.
4. Adjudication Method for Test Set
Not applicable, as this is bench testing against a standard, not a human reader study requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a bench study comparing a new device against a standard and a predicate device's performance through physical and chemical property testing. It is not an MRMC study comparing human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical dental device (cement), not an algorithm or software.
7. Type of Ground Truth Used
The ground truth used for this study is based on established industry standards, specifically ISO 4049:2019 (Dentistry Polymer-based restorative materials). This standard defines the acceptable ranges and properties for dental cements. Additionally, the comparison to a legally marketed predicate device (G-CEM LinkAce) serves as a comparative ground for substantial equivalence.
8. Sample Size for Training Set
Not applicable. This is a physical dental device subjected to bench testing, not an AI/ML algorithm that requires a training set.
9. How Ground Truth for Training Set was Established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 19, 2022
Spident Co., Ltd. Eunok Choi Manager 203 & 312, Korea Industrial Complex, 722 Gojan-Dong, Namdong-Gu, Incheon 405-821 SOUTH KOREA
Re: K214076
Trade/Device Name: EsCem Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: November 9, 2022 Received: November 18, 2022
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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
Michael E. Adjodha -S
Michael E. Adjodha, M.ChE. 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) K214076
Device Name EsCem
Indications for Use (Describe)
Final cementation of all-ceramic, metal-based inlays, onlays, posts, crown and bridge
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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K214076
Image /page/3/Picture/1 description: The image shows the word "SPIDENT" in green font. The letters are enclosed in a green box. The box is open on the top and left sides, with the letters "SP" outside of the box and the letters "IDENT" inside of the box. The background is white.
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
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92(c).
Date: December 22, 2021
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 : J.M. Ahn / President
2. Device Name and Classification
Proprietary Name : EsCem Common name : Self-Adhesive Resin Cement Classification name : Dental Cement [CFR 872.3275] Product code : EMA Class : II
3. Predicate Devices (Legally Marketed Devices)
The predicate devices for EsCem is :
- G-CEM LinkAce (GAM-200), GC AMERICA INC., K120243
4. Description:
EsCem is a dual-cured resin cement that can be self-etched and self-adhesive. It is classified as type 2 and class 3 according to ISO 4049. It is easy to handle with 'one step' system that does not need pre-treatment process, and it is easy to remove excess cement, so it is possible to perform quick operation. It is also easy to identify because it has a radio-opacity(1.2mm Al). And it offers various shades for aesthetics and color stable.
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Image /page/4/Picture/0 description: The image is a logo for Spident. The logo is green and features the word "SPIDENT" in a bold, sans-serif font. The word is enclosed in a square frame, with the top and bottom lines of the frame extending beyond the sides of the word. The logo is simple and modern, and the green color gives it a fresh and natural feel.
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
5. Indications for Use
Final cementation of all-ceramic, metal-based inlays, onlays, posts, crown and bridge
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.
| Performance | Test method | Requirement |
|---|---|---|
| Film thickness | ISO 4049:2019-7.5 Measurement of film thickness of luting materials | shall be no greater than 50 μm. |
| Working time | ISO 4049:2019-7.7 Working time, Class 1 and Class 3 luting materials | during its formation there shall be no detectable change in its homogeneity. |
| Setting time | ISO 4049:2019-7.8 Setting time, Class 1 and Class 3 materials | shall be no more than 10 min. |
| Flexural strength | ISO 4049:2019-7.11 Flexural strength | shall be equal to or greater than 50 MPa |
| Water sorption | ISO 4049:2019-7.12 Water sorption and solubility | shall be equal to or less than 40 µg/mm³. |
| Solubility | ISO 4049:2019-7.12 Water sorption and solubility | shall be equal to or less than 7,5 µg/mm³. |
| Radio-opacity | ISO 4049:2019-7.14 Radio-opacity | shall be equal to or greater than that of the same thickness of aluminium |
| Sensitivity to light | ISO 4049:2019-7.9 Sensitivity to light, Class 2 materials | the material shall remain physically homogeneous. |
| Color stability | ISO 4049:2019-7.13 Shade and colour stability after irradiation and water sorption | no more than a slight change in colour shall be observed |
- · 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
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Image /page/5/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-shaped border that is open on the left and right sides. 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
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 7405:2018, Dentistry Evaluation of biocompatibility of medical devices used in dentistry
| Product Name | EsCem | G-CEM LinkAce |
|---|---|---|
| 510(k) | N/A | K120243 |
| Manufacturer | SPIDENT CO., LTD. | GC Corporation |
| Product description | EsCem is a dual-cured resin cementthat can be self-etched and self-adhesive and is classified as type 2and class 3 according to ISO 4049.It is easy to handle with 'one step'system that does not need pre-treatment process, and it is easy toremove excess cement, so it ispossible to perform quickoperation. It is also easy to identifybecause it has a radiopaque. And itoffers various shades for aesthetics. | GC G-CEM LinkAce is a dual-cureself-adhesive universal resin lutingcement delivered in double barrelautomix syringe, designed for theadhesive luting of all-ceramic,metal or composite indirectrestorations. |
| Chemicalcomposition ofResin | Methacrylate monomerFillerInitiatorInhibitorpigment | Methacrylate monomerFillerInitiatorInhibitorpigment |
| Indications for use | Final cementation of all-ceramic,metal-based inlays, onlays, posts,crown and bridge | - Cementation of all types of allceramic, resin and metal-basedinlays, onlays, crowns and bridges.- Cementation of metal, ceramic,fibre posts, and cast post and cores. |
| Principle ofoperation | Dual cured | Dual cured |
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 bold, sans-serif font. The word is enclosed in a square bracket that is missing the top right corner. The logo is simple and modern.
SPIDENT CO., JLTD.
203 & 312, Korea Industrial Complex, 722, Gojan-Dong, NamdongGu, Incheon, Korea 405-821
Tel : +82-32-821-0071 Fax : + 82-32-821-0074
| MechanicalProperties | ||
|---|---|---|
| • Setting time (sec) | Less than 600 sec | Less than 600 sec |
| • Flexural strength(MPa) | More than 50 | More than 50 |
| • Film thickness(μm) | Less than 50 | Less than 50 |
| • Water sorption(µg/mm³) | Less than 40 | Less than 40 |
| • Solubility(µg/mm³) | Less than 7.5 | Less than 7.5 |
| • Radio-opacity(mmAl) | More than 1 mm | More than 1 mm |
| Standardconformed | ISO 4049 | ISO 4049 |
| Biocompatibility | Yes | Yes |
| Light Curing Time | 20 Seconds | 20 Seconds |
| Application Area | Tooth | Tooth |
| Target Population | Dental patient | Dental patient |
| Intended Operator | Dentist | Dentist |
| Storage condition | 2-27°C | 4-25°C |
| Shade | A2, A3, TW | A2, AO3, BO1, Translucent |
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Image /page/7/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 all capitalized and are a light shade of green. The word is enclosed in a square border that is also green.
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
9. Similarities and Differences with Marketed Devices:
The subject device, EsCem and the predicate device, G-CEM LinkAce (GAM-200) was compared as above. Both products have the similar product description as a dental cement. In case of composition, two products contain slightly different raw materials, but the subject device and the predicate device show the same performance as monomer, filler, photo inhibitor (stabilizer), self-cure initiator, photo initiator and pigment. For this reason, despite difference in material, both the subject device and the equivalent device have no problem in terms of the clinical performance.
Indication for use of the two products are almost same and both products can be used as dual cure. The performance results of the two products are not the same, but both products meet the requirements of ISO 4049. Biocompatibility, Light Curing Time, Application Area, Target Population, Intended Operator of both products are the same. In case of Storage condition and Shade, there is a slight difference but performance and biocompatibility test showed that these differences would not raise any new questions of safety and effectiveness. Therefore, EsCem is substantially equivalent with predicate device, G-CEM LinkAce, and at least as safe and effective as the predicate device.
10. Conclusion
Based on a comparison of subject device, EsCem (SPIDENT CO., LTD) and predicate device, G-CEM LinkAce (GC America INC.), it is confirmed that the subject device is substantially equivalent to predicate device.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.