Bright MTA Sealer Plus

{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 & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 28, 2023 Genoss Co., Ltd. Boram Choi Assistant Manager D-factory, 56, Changnyong-daero 256beon-gil, Yeongtong-gu Suwon-si. Gyeonggi-do 16229 SOUTH KOREA Re: K231480 Trade/Device Name: Bright MTA Sealer Plus Regulatory Class: Class II Product Code: KIF Dated: April 5, 2023 Received: May 22, 2023 Dear Boram 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 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, # Michael E. Adjodha -S Michael 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) K231480 Device Name Bright MTA Sealer Plus Indications for Use (Describe) Bright MTA Sealer Plus is used for filling root canals 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The first three letters, "GEN", are in a dark green color. The last three letters, "OSS", are in a lighter green color. ## 510(k) Summary 02/05/2023 ### 1. Company | | Submitter | |----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | GENOSS Co., Ltd. | | Address | Head office: 1F Gyeonggi R&DB center, 105 Gwanggyo-ro, Yeongtong-gu,<br>Suwon-si, Gyeonggi-do, 16229, Republic of Korea<br>Factory: D-factory, 56, Changnyong-daero 256beon-gil, Yeongtong-gu,<br>Suwon-si, Gyeonggi-do, 16256, Republic of Korea | | Phone/Fax | +82-70-7098-6352/ +82-31-888-5595 | | Contact person | Boram Choi / RA<br>brchoi@genoss.com | | Summary Date | 02/05/2023 | ### 2. Device | Proprietary name: | Bright MTA Sealer Plus | |----------------------|--------------------------| | Common Name: | Root filling material | | Classification Name: | Root canal filling resin | | Regulation Number: | 21 CFR 872.3820 | | Product Code: | KIF | | Regulatory Class: | Class II | ### 3. Predicate Device K170175 Endoseal MTA #### 4. Device Description Bright MTA Sealer Plus is a ready-to-use, injectable paste-like material for root canal filling, which is hardened and obturated after being injected into the root canal space. The product based on calcium silicate exhibits excellent biocompatibility as well as a low film thickness suitable for easy penetration of lateral and accessory canals. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The first three letters, "GEN", are in a dark green color. The last three letters, "OSS", are in a lighter green color. #### 5. Indication for use Bright MTA Sealer Plus is used for filling root canals. #### 6. Technological Characteristics Bright MTA Sealer Plus was compared with the predicate device 'ENDOSEAL MTA' in clinical, technical, biological view. The characteristics that differed from the predicate device were performed by gap analysis, which confirmed equivalence with the predicate device. Technological characteristics of Bright MTA Sealer Plus and ENDOSEAL MTA are as following; | Device name | | SUBJECT DEVICE | PREDICATED DEVICE | |-------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | | | Bright MTA Sealer Plus | Endoseal MTA<br>(K170175) | | | Manufacture | Genoss Co.,Ltd. | Maruchi | | | Classification | Class II | Class II | | | Product code | KIF | KIF | | Clinical | Target population | Human tooth root canal | Human tooth root canal | | | Purpose | Bright MTA Sealer Plus is used for<br>filling root canals. | Materials used for root canal filling | | | Site of application | root canal | root canal | | | Clinical<br>Performance | Repair of root resorption<br>Root-end-filling | Repair of root resorption<br>Root-end-filling | | | Principle of<br>operation | Bright MTA Sealer Plus is an injectable<br>paste like material for root canal filling,<br>which is hardened and obturated after<br>being injected into the root canal space. | Endoseal MTA is an endodontic sealer<br>based on MTA, providing a root canal<br>filling. | | Technical | Solubility | 0.2 % | 0.7 % | | | Flow test | 27 mm | 21 mm | | | Setting time | Within 360 min | 12.31 min | | | Film Thickness | 30 μm | 15 μm | | | Radio-opacity | 4.6 mm | 10.5 mm | | B1010 | Material | CaCO3, Al2O3, SiO2, NaHCO3<br>(Calcium silicate)<br>ZrO₂, Li₂Co₃, 1,3-Propandiol | CaCO3, Al2O3, SiO2, Fe2O3<br>(Natural pure cement)<br>ZrO₂, Bi₂O₃, Bentonite Clay | {5}------------------------------------------------ | | | Polyethylene glycol,<br>Polar acidic ester of long chain<br>alcohols | N-Methyl-2-Pyrrolidone,<br>Hypromellose | |--|---------------------|----------------------------------------------------------------------|--------------------------------------------| | | Chemical Safety | Biocompatible | Biocompatible | | | Sterile | Non sterile | Non sterile | | | Shelf-Life | 2 years | 2 years | | | Packaging | Pre-loaded syringe | Pre-loaded syringe | | | Duration of Contact | Permanent contact - contact exceeds<br>30d | Permanent contact - contact exceeds<br>30d | #### 7. Performance Data #### Biocompatibility testing Biocompatibility testing on the proposed Bright MTA Sealer has been completed. Requirements for biological evaluation of the proposed device were based on FDA recognized concensus standard of ISO10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and nonsensitizing to biological bone and tissues with its intended use. The following biocompatibility tests were completed: | No. | Test | Standard & Method | Acceptance criteria | Evaluation | |-----|-----------------------------|----------------------------------------|---------------------------------------|-----------------------------------| | 1 | Cytotoxicity | EN ISO 10993-5<br>Agar diffusion assay | Non cytotoxic<br>(Scale 0) | Scale 0<br>(Non cytotoxic) | | 2 | Oral mucosal<br>irrittation | EN ISO 10993-23 | Irritation index 0 | Irritation index 0 | | 3 | Skin Sensitization | EN ISO 10993-10<br>GPMT | Sensitization score<br>and rate 0 | Sensitization score and<br>rate 0 | | 4 | Acute systemic<br>toxicity | EN ISO 10993-11<br>Single dose | No Acute systemic<br>toxicity | No Acute systemic<br>toxicity | | 5 | Systemic toxicity | EN ISO 10993-11<br>Pyrogen test | No abnormal signs<br>and dead | No abnormal signs and<br>dead | | 6 | Genotoxicity | EN ISO 10993-3<br>Back mutation. | No back mutation<br>regardless of the | No back mutation | {6}------------------------------------------------ | | | Chromosomal<br>aberration | presence or absence<br>of a metabolic<br>activation system | | |----|-------------------------|----------------------------------------|------------------------------------------------------------|-------------------------------------------------| | | | | No chromosomal<br>aberration in<br>CHL/IU cells | No chromosomal<br>aberration in CHL/IU<br>cells | | 7 | Implantation | EN ISO 10993-6<br>Implantation | Biocompatible | Biocompatible | | 8 | Sub-chronic<br>toxicity | EN ISO 10993-11<br>Subchronic toxicity | No Subchronic<br>toxicity | No Subchronic<br>toxicity | | 9 | Chronic toxicity | EN ISO 10993-11<br>Chronic toxicity | No chronic toxicity | No chronic toxicity | | 10 | Carcinogenicity | EN ISO 10993-3<br>Carcinogenicity | No Carcinogenicity | No Carcinogenicity | ### Mechanical testing The proposed Bright MTA Sealer Plus was evaluated using the following performance bench testing to confirm the performance characteristics: | No. | Items | Standard &<br>Method | Acceptance Criteria | Result | |-----|---------------------------|----------------------------------|-------------------------------------------------------------|--------------------------------------------------------------------------------| | 1 | Visual test | ISO 4049<br>Bare eyes | No alien substance and<br>suitable for using the<br>product | No alien substance and<br>suitable for using the<br>product | | 2 | Capacity test | ISO 4049<br>Weight<br>difference | Standard weight $\pm$ ±5% | 1.50 % | | 3 | Package test | ISO 4049<br>Bare eyes | No damages, cracks | The package was<br>completely sealed, and<br>there were no damages.<br>cracks. | | 4 | Extraneous<br>matter test | ISO 4049<br>Bare eyes | No extraneous matter | No Extraneous Matter | | 5 | Flow test | EN ISO 6876:<br>2012 5.2 | Diameter ≥ 17mm | 27mm | | 6 | Setting time test | EN ISO 6876:<br>2012 5.4 | ≤ 360 min | Within 360min | | 7 | Film thickness<br>test | EN ISO 6876:<br>2012 5.5 | ≤ 50 $\mu$ m | 30 $\mu$ m | | 8 | Radio-opacity<br>test | EN ISO 6876:<br>2012 5.7 | More than 3mm | 4.6mm | | 9 | Solubility test | EN ISO 6876:<br>2012 5.6 | ≤ 3% | 0.2% | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The first three letters, "GEN", are in a dark green color, while the last three letters, "OSS", are in a lighter green color. The letters are connected, forming a single word. All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bright MTA Sealer Plus met the established specifications necessary for consistent performance according to its intended use. #### 8. Conclusion Based on the information provided in this premarket notification of GENOSS Co., Ltd. concluded that Bright MTA Sealer Plus is acceptable and safe, substantially equivalent to predicate device.