EsCem

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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. {4}------------------------------------------------ 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<br>-7.5 Measurement of film thickness of luting materials | shall be no greater than 50 μm. | | Working time | ISO 4049:2019<br>-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<br>-7.8 Setting time, Class 1 and Class 3 materials | shall be no more than 10 min. | | Flexural strength | ISO 4049:2019<br>-7.11 Flexural strength | shall be equal to or greater than 50 MPa | | Water sorption | ISO 4049:2019<br>-7.12 Water sorption and solubility | shall be equal to or less than 40 µg/mm³. | | Solubility | ISO 4049:2019<br>-7.12 Water sorption and solubility | shall be equal to or less than 7,5 µg/mm³. | | Radio-opacity | ISO 4049:2019<br>-7.14 Radio-opacity | shall be equal to or greater than that of the same thickness of aluminium | | Sensitivity to light | ISO 4049:2019<br>-7.9 Sensitivity to light, Class 2 materials | the material shall remain physically homogeneous. | | Color stability | ISO 4049:2019<br>-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 {5}------------------------------------------------ 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 cement<br>that can be self-etched and self-<br>adhesive and is classified as type 2<br>and class 3 according to ISO 4049.<br>It is easy to handle with 'one step'<br>system that does not need pre-<br>treatment process, and it is easy to<br>remove excess cement, so it is<br>possible to perform quick<br>operation. It is also easy to identify<br>because it has a radiopaque. And it<br>offers various shades for aesthetics. | GC G-CEM LinkAce is a dual-cure<br>self-adhesive universal resin luting<br>cement delivered in double barrel<br>automix syringe, designed for the<br>adhesive luting of all-ceramic,<br>metal or composite indirect<br>restorations. | | Chemical<br>composition of<br>Resin | Methacrylate monomer<br>Filler<br>Initiator<br>Inhibitor<br>pigment | Methacrylate monomer<br>Filler<br>Initiator<br>Inhibitor<br>pigment | | Indications for use | Final cementation of all-ceramic,<br>metal-based inlays, onlays, posts,<br>crown and bridge | - Cementation of all types of all<br>ceramic, resin and metal-based<br>inlays, onlays, crowns and bridges.<br>- Cementation of metal, ceramic,<br>fibre posts, and cast post and cores. | | Principle of<br>operation | Dual cured | Dual cured | ## 8. Substantial Equivalence Discussion {6}------------------------------------------------ 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 | Mechanical<br>Properties | | | |------------------------------|-------------------|---------------------------| | • Setting time (sec) | Less than 600 sec | Less than 600 sec | | • Flexural strength<br>(MPa) | More than 50 | More than 50 | | • Film thickness<br>(μm) | Less than 50 | Less than 50 | | • Water sorption<br>(µg/mm³) | Less than 40 | Less than 40 | | • Solubility<br>(µg/mm³) | Less than 7.5 | Less than 7.5 | | • Radio-opacity<br>(mmAl) | More than 1 mm | More than 1 mm | | Standard<br>conformed | 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 | {7}------------------------------------------------ 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.