Bright Low Flow

{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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 27, 2020 Genoss co.,Ltd. Hong Jeon Manager 1F, Gyeonggi R&DB Center, 105 Gwanggyo-ro, Yeongtong-gu, Suwon-si Suwon-si, Gyeonggi-do 16229 South Korea Re: K200156 Trade/Device Name: Bright Low Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: Class II Product Code: EBF Dated: August 3, 2020 Received: August 3, 2020 Dear Hong Jeon: 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, for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The letters "GENO" are in a dark green color, while the letters "OSS" are in a lighter green color. The font is bold and slightly italicized, giving the word a dynamic appearance. ## Indication for use 510(k) Number: K200156 Device Name: Bright Low Flow #### Indication for use: 1) Class I, III, V (non-stress area, minimally invasive restoration) 2) Composite resin repair Prescription Use _ √ _ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Indication for use {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for GENOSS. The logo is in green and features the word "GENOSS" in a stylized font. The first four letters, "GENO", are in a darker green, while the last two letters, "SS", are in a lighter green. The logo has a modern and clean design. ## 510(k) Summary K200156 12/20/2019 #### 1. Company | | Submitter | |----------------|----------------------------------------------------------------------------------------------------------| | Name | GENOSS Co., Ltd. | | Address | 1F, Gyeonggi R&DB Center / 226, 2F, GSBC, 105<br>Gwanggyo-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea | | Phone/Fax | +82-70-7098-7541/ +82-31-888-5105 | | Contact person | HongJun Jeon / RA<br>hjjeon@genoss.com | | Summary Date | 12/20/2019 | #### 2. Device Name Proprietary name: Bright Low Flow Regulation description : Light-cured Flowable Composite Resin Classification name: Tooth shade resin material #### 3. Predicate Device K091388 G-aenial Universal Flo #### 4. Description Bright Flow is a light-cured flowable composite resin. It comprises two different types of flowability (Low Flow and High Flow) and 9 shades depending on the intended use, which enables aesthetic and durable outcomes for anterior and posterior composite restorations. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The first four letters, "GENO", are in a dark green color, while the last two letters, "SS", are in a lighter, lime green color. The letters are connected, giving the word a flowing appearance. #### 5. Indication for use - 1) Class I, III, V (non-stress area, minimally invasive restoration) - 2) Composite resin repair #### 6. Technological Characteristics Bright Low Flow has the similar technological characteristics as the predicate device; main material, indication for use and design. Technological characteristics of Bright Low Flow, Gaenial Universal Flo are as following. | Device name | Bright Low Flow | G-aenial Universal Flo | | |---------------|----------------------|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Genoss Co., Ltd. | GC America, Inc. | | | 510(k) Number | New Device | K091388 | | | Clinical | Target population | Human tooth | Human tooth | | | Purpose | Direct restoration | Direct restoration | | | Site of application | Dentin, Enamel | Dentin, Enamel | | | Clinical Performance | High flexural strength and strong bonding | High flexural strength and strong bonding | | Biological | Materials | Methacrylate resins, Fillers (Barium glass, Silica) | Methacrylate resins, Fillers (Barium glass, Silica) | | | Chemical Safety | Biocompatible | Biocompatible | | | Sterilization | Non-sterile | Non-sterile | | | Shelf-Life | 2 years | 3 years | | Technical | Form | Paste | Paste | | | Indication for use | 1) Class I, II, III, V (non-stress area, minimally invasive restoration)<br>2) Composite resin repair | 1) Direct restorative for Class I, IV, III, II and V cavities.<br>2) Fissure sealant<br>3) Sealing hypersensitive areas<br>4) Repair of (in) direct aesthetic restorations, temporary crown & | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The letters "GENO" are in a dark green color, while the letters "SS" are in a lighter green color. The font is bold and sans-serif, and the letters are slightly slanted to the right. | | | bridge, defect margins when margins<br>are in enamel<br>5) Blocking out undercuts<br>6) Liner or base | |-------------------|------------------|-------------------------------------------------------------------------------------------------------| | Use | Prescription | Prescription | | Depth of cure | 2.9 mm | 2.8 mm | | Water Sorption | 23 $\mu g/mm^3$ | Less than 40 $\mu g/mm^3$ | | Solubility | 0.9 $\mu g/mm^3$ | Less than 7.5 $\mu g/mm^3$ | | Flexural Strength | 142 Mpa | 167 Mpa | | Radio-opacity | 1.81 | More than Aluminum | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The letters "GEN" are in a dark green color, while the letters "OSS" are in a lighter, lime green color. The font is bold and slightly rounded, giving the word a modern and professional appearance. #### 7. Performance Data Biocompatibility testing on the proposed Bright Low Flow 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 non-sensitizing to biological bone and tissues with its intended use. The following biocompatibility tests were completed: (P: Pass, F: Fail) | No. | Test | Method | Acceptance criteria | P/F | Report No. | |-----|-------------------------|--------------|---------------------------|-----|-----------------| | 1 | Cytotoxicity | ISO 10993-5 | None cytotoxicity | P | CDM-18-0057-12 | | 2 | Irritation | ISO 10993-10 | None oral irritation | P | MTK-2018-000704 | | 3 | Sensitization | ISO 10993-10 | None sensitization | P | MTK-2018-000703 | | 4 | Acute systemic toxicity | ISO 10993-11 | None systemic<br>toxicity | P | MTK-2018-000703 | | 5 | Genotoxocity | ISO 10993-3 | None genotoxicity | P | MTK-2018-000702 | | 6 | Implantation | ISO 10993-6 | Biocompatible | P | BER-18-027 | | 7 | Chronic toxicity | ISO 10993-11 | No chronic toxicity | P | BER-18-027 | {7}------------------------------------------------ # GENO The proposed Bright Low Flow was evaluated using the following performance bench testing to confirm the performance characteristics: | No. | Items | Method | Acceptance<br>Criteria | Result | File No. | |-----|---------------------------------|----------|--------------------------------------------------|-----------------------------------------------------------|--------------------| | 1 | Visual | ISO 4049 | No impurities<br>and No specific<br>changes | No impurities<br>and No specific<br>changes | CDM-18-<br>0057-01 | | 2 | Capacity | ISO 4049 | Capacity error of;<br>Standard Capacity <<br>±5% | Size error of;<br>Standard Size < ±5%<br>H 0.43%, Ø 0.03% | CDM-18-<br>0057-02 | | 3 | Package | ISO 4049 | No damage | No damage | CDM-18-<br>0057-03 | | 4 | Sensitivity to<br>Ambient Light | ISO 4049 | Must be<br>physically uniform | Uniformity | CDM-18-<br>0057-04 | | 5 | Depth of Cure | ISO 4049 | More than 1.5 mm | Average: 2.9 mm | CDM-18-<br>0057-05 | | 6 | Shade | ISO 4049 | Must be shade<br>uniform | Uniformity | CDM-18-<br>0057-06 | | 7 | Color Stability | ISO 4049 | Color should be<br>stable | Stable | CDM-18-<br>0057-07 | | 8 | Flexural<br>Strength | ISO 4049 | More than 80 MPa | Average: 142 MPa | CDM-18-<br>0057-08 | | 9 | Water Sorption | ISO 4049 | Less than 40 µg<br>/mm3 | Average: 23 µg/mm3 | CDM-18-<br>0057-09 | | 10 | Solubility | ISO 4049 | Less than 7.5 µg<br>/mm3 | Average: 0.9 µg/mm3 | CDM-18-<br>0057-10 | | 11 | Radio-opacity | ISO 4049 | More than Al | ≥ Al (1.81) | CDM-18-<br>0057-11 | All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bright Low Flow met the established specifications necessary for consistent performance according to its intended use. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The letters "GENO" are in a dark green color, while the letters "SS" are in a lighter green color. The font is bold and slightly italicized, giving the word a dynamic appearance. ### 8. Conclusion Based on the information provided in this premarket notification of GENOSS Co., Ltd. Concludes that Bright Low Flow is acceptable and safe, substantially equivalent to predicate devices.