rainbow Paste Stain SE

{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. June 21, 2024 Genoss Co., Ltd. Hayoung Sung Official Correspondent 12F, 76, Changryong-daero 256beon-gil, Yeongtong-gu Suwon-si, Gyeonggi-do SOUTH KOREA Re: K233885 Trade/Device Name: rainbow Paste Stain SE Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: November 15, 2023 Received: December 8, 2023 Dear Hayoung Sung: 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. {1}------------------------------------------------ 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" (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 QS 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. 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, # Michael E. Adjodha -S Michael E. Adjodha, MChE, 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 Submission Number (if known) K233885 Device Name rainbowTM Paste Stain SE Indications for Use (Describe) rainbow Paste Stain SE is indicated for use as a veneering material for fixed prosthesis in crowns and bridges. This device is used in prosthetic dentistry by forming a porcelain veneer on to a ceramic substructure. 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. 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}------------------------------------------------ Image /page/4/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, with a slightly rounded appearance. # 510(k) Summary - K233885 06/18/2024 ## 1. Company | | Submitter | |----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | GENOSS Co., Ltd. | | Address | Head Office: 12F, 76, Changnyong-daero 256beon-gil, Yeongtong-gu,<br>Suwon-si, Gyeonggi-do, Republic of Korea<br>Manufacturing site: 1F 106, Jeongoksandan-ro, Seosin-myeon, Hwaseong-<br>si, Gyeonggi-do, Republic of Korea | | Phone/Fax | +82-70-7098-8920 | | Contact person | Hayoung Sung/ RA<br>hysung@genoss.com | | Summary Date | 06/18/2024 | #### 2. Device Name | Proprietary name: | rainbow™ Paste Stain SE | |-------------------------|-----------------------------------| | Regulation description: | Porcelain Powder for clinical use | | Classification name: | Powder, Porcelain | | Regulation Number: | 21 CFR 872.6660 | | Product Code: | EIH | # 3. Predicate Device #### 4. Description rainbow™ Paste Stain SE is a dental veneering material in paste form used for color staining and glazing of the surfaces of restorations such as porcelain-fused zirconia, full-contoured zirconia, or lithium disilicate. The intended use of general porcelain is to make artificial teeth (dental prosthesis) more similar with natural teeth. The subject device is pre-mixed paste form, which can help dental technicians exclude mixing process of porcelain powder and liquid. #### 510(k) Summary Page 1 of 4 {5}------------------------------------------------ Image /page/5/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 rainbow™ Paste Stain SE is indicated for use as a veneering material for fixed prosthesis in crowns and bridges. This device is used in prosthetic dentistry be forming a porcelain veneer on to a ceramic substructure. #### 6. Technological Characteristics rainbow™ Paste Stain SE was compared with the predicate device 'rainbow™ Paste Stain' 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 rainbow™ Paste Stain SE and rainbow™ Paste Stain Material are as following; | Device name | rainbow™ Paste Stain SE | rainbow™ Paste Stain | | |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | Manufacture | Genoss Co.,Ltd. | Genoss Co., Ltd. | | | 510(K) Number | K233885 | K151731 | | | Classification | Class II | Class II | | | Product code | EIH | EIH | | | Indication for use | rainbow™ Paste Stain SE is indicated<br>for use as a veneering material for<br>fixed prosthesis in crowns and<br>bridges. This device is used in<br>prosthetic dentistry be forming a<br>porcelain veneer on to a ceramic<br>substructure. | rainbow™ Paste Stain is<br>indicated for use as a veneering<br>material for fixed prosthesis in<br>crowns and bridges. This device<br>is used in prosthetic dentistry be<br>forming a porcelain veneer on to<br>a ceramic substructure. | | | Form | Paste | Paste | | | Use | Prescription | Prescription | | | Type, Class of<br>dental ceramic of<br>ISO 6872 | Type I - Class I | Type I - Class I | | | Technical | Flexural strength | 72.5 MPa | 79 MPa | | | Chemical solubility<br>(µg/cm²) | 31.3 | 24 | | | Linear thermal<br>expansion<br>coefficient | $(8.6±0.5) x 10^{-6}k^{-1}$ | $(9.5±0.5) x 10^{-6}k^{-1}$ | {6}------------------------------------------------ | | Glass transition<br>temperature | 503.6°C | 476°C | |------------|---------------------------------|---------------|---------------| | Biological | Chemical Safety | Biocompatible | Biocompatible | | | Sterilization | Non-sterile | Non-sterile | # 7. Biocompatibility Data Biocompatibility testing on the proposed rainbow™ Paste Stain SE 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 | |-----|-----------------------------------------|--------------|---------------------------|-----| | 1 | Cytotoxicity | ISO 10993-05 | None cytotoxicity | P | | 2 | Sensitization | ISO 10993-10 | None sensitization | P | | 3 | Irritation or intracutaneous reactivity | ISO 10993-10 | None irritation | P | | 4 | Systemic toxicity(acute) | ISO 10993-11 | None systemic<br>toxicity | P | | 5 | Genotoxicity | ISO 10993-03 | No Toxicity | P | | 6 | Subchronic toxicity | ISO 10993-11 | No Toxicity | P | | 7 | Implantation | ISO 10993-06 | No Toxicity | P | | 8 | Chronic toxicity | ISO 10993-11 | No Toxicity | P | | 9 | Carcinogenicity | ISO 10993-03 | No Toxicity | P | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The first four letters, "GENO," are a dark green color. The last two letters, "SS," are a lighter green color, creating a gradient effect. The font is bold and sans-serif. ### 8. Performance Data The proposed rainbow™M Paste Stain SE was evaluated using the following performance bench testing to confirm the performance characteristics: | No. | Items | Criteria | Result | Standard | |-----|---------------------------------|---------------------------------------------------------|------------------------------------------|----------------------| | 1 | Appearance | No impurities<br>and No specific changes | No impurities<br>and No specific changes | Internal<br>Standard | | 2 | Weight | Standard weight <±5% | Standard weight <±5% | Internal<br>Standard | | 3 | Package | No damage | No damage | Internal<br>Standard | | 4 | Uniformity | After firing, the color shall<br>be uniformly dispersed | Uniform | ISO 6872<br>5.1 | | 5 | Extraneous materials | Free from<br>extraneous materials | Free from<br>extraneous materials | ISO 6872<br>5.2 | | 6 | Radioactivity | ²³⁸U Less than 1.0 Bq/g | ²³⁸U less than 0.001 Bq/g | ISO 6872<br>7.2 | | 7 | Chemical solubility | Less than 100 µg/cm² | Solubility: 31.3 µg/cm² | ISO 6872<br>7.6 | | 8 | Flexural strength | More than 50MPa | Average: 72.5MPa | ISO 6872<br>7.3 | | 9 | Linear thermal<br>expansion | N/A | Average: $8.6 × 10⁻⁶ K⁻¹$ | ISO 6872<br>7.4 | | 11 | Glass transition<br>temperature | N/A | Average: 503.6°C | ISO 6872<br>7.5 | All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the rainbow™ Paste Stain SE met the established specifications necessary for consistent performance according to its intended use. # 9. Conclusion Based on the information provided in this premarket notification of GENOSS Co., Ltd. concluded that rainbow™ Paste Stain SE is substantially equivalent to predicate device.