VioSeal

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 7, 2024 Spident Co., Ltd. Eunok Choi RA Manager 203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu Incheon, Incheon 405-821 Korea, South Re: K242702 Trade/Device Name: VioSeal Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: September 6, 2024 Received: September 9, 2024 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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). {2}------------------------------------------------ Sincerely, # Bobak Shirmohammadi -S For Michael E. Adjodha, M.ChE., RAC, 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 {3}------------------------------------------------ ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K242702 Device Name VioSeal Indications for Use (Describe) Permanent obturation of root canals of the permanent teeth in combination with root canal points Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 20px">☒</span> | |----------------------------------------------|----------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <span>☐</span> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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." {4}------------------------------------------------ | K242702 | | |---------|-------------------------| | | 510(k) Summary | | | Prepared on: 2024-10-30 | | | 21 CFR 807.92(a)(1) | | Contact Details | | |-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------| | Applicant Name | SPIDENT CO., LTD. | | Applicant Address | 203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu,<br>Incheon, Korea, 405-821 Incheon Incheon 405-821 Korea, South | | Applicant Contact Telephone | +821042226153 | | Applicant Contact | Mrs. Eunok Choi | | Applicant Contact Email | eochoi@spident.co.kr | | Device Name | | |---------------------|---------------------------| | | 21 CFR 807.92(a)(2) | | Device Trade Name | VioSeal (VioSeal) | | Common Name | Root canal filling resin | | Classification Name | Resin, Root Canal Filling | | Regulation Number | 872.3820 | | Product Code(s) | KIF | | Legally Marketed Predicate Devices | | | |------------------------------------|----------------------------------------------------------|--------------| | | 21 CFR 807.92(a)(3) | | | Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | | K960548 | AH PLUS ROOT CANAL SEALER | KIF | | Device Description Summary | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------| | | 21 CFR 807.92(a)(4) | | VioSeal is the epoxy resin-based root canal sealer in the dual syringe for easy mixing and injection and is mixed with the 1:1 mixing ratio. It contains inorganic fillers which has good biocompatibility, physical and chemical properties and produces a complete obturation. Therefore, VioSeal has good biocompatibility with the root canal tissues. | | | Intended Use/Indications for Use | | |--------------------------------------------------------------------------------------------------|---------------------| | | 21 CFR 807.92(a)(5) | | Permanent obturation of root canals of the permanent teeth in combination with root canal points | | | Indications for Use Comparison | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------| | | 21 CFR 807.92(a)(5) | | Indication for use of the two products are almost same. The expression is a little different, but both devices are used for permanent obturation of root canals of the permanent teeth in combination with root canal points. | | | Technological Comparison | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------| | | 21 CFR 807.92(a)(6) | | The performance results of the two products are not the same, but both products meet the requirements of ISO 6876. Biocompatibility, Delivery form, Application Area, Intended Operator of both products are the same. Target population is different, but our device has narrow target population than predicate device. In case of Storage condition, 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, VioSeal is substantially equivalent with predicate device, AH PLUS ROOT CANAL SEALER, and at least as safe and effective as the predicate device. | | {5}------------------------------------------------ #### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) Flowability, working time, setting time, film thickness, solubility, and radio-opacity was conducted in accordance with ISO 6876. Not Applicable Flowablity, working time, setting time, film thickness, solubility, radio-opacity test results meet the lSO 6876 requirements. This result showed that the subject device is as good as the predicate device. Therefore, It can be considered that our subject device is as safe, effective and performs as well as or better than the predicate device.