rainbow LS Block

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, conveying the department's authority and purpose. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 21, 2016 GENOSS Co., Ltd. % Kim Byungsun Assistant Manager ICT America, Inc. 180 Sylvan Avenue, 2nd Floor Englewood Cliffs. New Jersey 07632 Re: K160144 Trade/Device Name: rainbow™ LS Block Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: June 13, 2016 Received: June 15, 2016 Dear Kim Byungsun: 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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Michael J. Ryan -S for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation 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 "SS" are in a lighter green color. The font is bold and sans-serif. # Indication for use 510(k) Number: Device Name: rainbow™ LS Block Indication for use: rainbow™ LS Block can be used for manufacturing Crown, Veneer, Inlay and Onlay. 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 contains 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 "OSS" are connected by a green line that runs underneath them. # 510(k) Summary 03/28/2016 ## 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 | +82-31-888-5100/ +82-31-888-5595 | | Contact person | Han Yein / RA<br>yihan@genoss.com | | Summary Date | 03/28/2016 | #### 2. Device Name | Proprietary name | : rainbow TM LS Block | |---------------------|-------------------------------------| | Regulation number | : 21 CFR 872.6660 | | Classification name | : Porcelain powder for clinical use | | Product code | : EIH | | Device class | : Class II | #### 3. Predicated Device K051705 IPS e.max CAD #### 4. Description rainbow™ LS Block is a dental ceramic made out of Lithium disilicate. rainbow™ LS Block is milled into cores of teeth and then is fired in a furnace to harden the Li2Si2O3. Then, the core is layered with porcelain to make a finished tooth. {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 slightly rounded, giving the word a modern and professional look. ## 5. Indication for use rainbow™ LS Block can be used for manufacturing Crown, Veneer, Inlay and Onlay. # 6. Technological Characteristics rainbow™ LS Block has the similar technological characteristics as the predicate device; main material, indication for use and design. Technological characteristics of rainbow™ LS Block, IPS e.max CAD is as following | Device name | rainbow™ LS Block | IPS e.max CAD | Comparison | | |----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Manufacturer | Genoss Co., Ltd. | ivoclar vivadent | N/A | | | 510(k) Number | New Device | K051705 | N/A | | | Materials | SiO2, Li2CO3, Ca3(PO4)2,<br>P2O5, ZnO, Al2O3, La2O3,<br>K2CO3, ZrO2 | SiO2, Li2O, K2O, MgO,<br>ZnO, Al2O3, P2O5, ZrO2 | Similar<br>The major materials of<br>lithium disilicate dental<br>ceramic(subject and<br>predicate device) are SiO2<br>and Li2O.<br>The each composition<br>of other materials is<br>less than 5%. | | | Form | Preformed block | Preformed block | Same | | | Type, class of<br>dental ceramic | Type II - Class 2 | Type II - Class 2 | Same | | | Sterilization | Non-sterile | Non-sterile | Same | | | Indication for use | rainbow™ LS Block can<br>be used for manufacturing<br>Crown, Veneer, Inlay and<br>Onlay. | IPS e.max CAD is a<br>CAD/CAM machinable<br>glass ceramic based on<br>lithium disilicate for the<br>preparation of full ceramic<br>crowns, inlays, onlays, and<br>full ceramic 3-unit anterior<br>bridges. | Similar<br>The subject has more<br>strong bending strength<br>than the predicate devices.<br>Subject not intended for<br>anterior bridges. | | | Use | Prescription | Prescription | Same | | | Technical characteristics | | | | | | Bending Strength<br>(Flexural strength) | 370MPa | 360MPa | Similar<br>Bending strength is<br>little higher than predicate<br>device but there is no<br>difference in performance<br>and safety. | | | Linear Thermal<br>expansion<br>( $10^{-6}K^{-1}$ ) | 10.3±0.5 | 10.45 | Same | | | Radioactivity<br>(Bq/g) | 0.00628 | <0.03 | Radioactivity is lower than<br>predicate device | | | Chemical Solubility<br>( $\mu g/cm^2$ ) | 12 | 40 | Chemical solubility<br>satisfies requirement by<br>ISO 6872:2008 for<br>Class 2 dental ceramics.<br>(< 100 $\mu g/cm^2$ ) | | | Glass transition<br>temperature | (579±20) °C | approx. 549 °C | Similar<br>Glass transition<br>temperature of the subject<br>and predicate device are<br>similar. Each have<br>individual sintering<br>schedule by glass<br>transition temperature. | | | Biocompatibility | None cytotoxicity<br>None sensitization<br>None systemic toxicity<br>None acute oral toxicity<br>None genotoxicity | None cytotoxicity<br>None sensitization<br>None systemic toxicity<br>None acute oral toxicity<br>None genotoxicity | same | | | Shapes<br>& Sizes | C-type<br>Image: C-type | Width 8.0~15.5mm<br>Length 8.0~15.5mm<br>Height 15.0~40mm | Width 12.5~15.85mm<br>Length 10.4~17.85mm<br>Height 15.0~38.95mm | Similar | | | Disk type<br>Image: Disk type | Width 15, 20mm<br>Length 22mm<br>Height 3, 5, 7, 9mm | Width 12.5~15.85mm<br>Length 10.4~17.85mm<br>Height 15.0~38.95mm | | 510(k) Summary {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 and are connected by a line at the bottom. {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 green color. The letters are connected to each other, and the overall design is modern and eye-catching. #### 7. Performance Data Biocompatibility testing on the proposed rainbow™ LS Block has been completed. Requirements for biological evaluation of the proposed device were based on FDA recognized consensus 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. | Items | Criteria | Result | Standard | |-----|-------------------------------------------|---------------------------------|---------------------------------|----------------------------| | 1 | Cytotoxicity | None cytotoxicity | None cytotoxicity | ISO 10993-5 | | 2 | Sensitization<br>(Local Lymph Node Assay) | None sensitization | None sensitization | ISO 10993-10 | | 3 | Oral mucosa irritation | Less than stimulus<br>threshold | Minimal irritation | ISO 10993-10 | | 4 | Acute systemic toxicity | None acute Systemic<br>toxicity | None acute Systemic<br>toxicity | ISO 10993-11 | | 5 | Genotoxicity<br>Ames<br>Micronucleus | None genotoxicity | None genotoxicity | ISO 10993-3<br>ISO 10993-3 | The proposed rainbow™ LS Block was evaluated using the following performance bench testing to confirm the performance characteristics: | No. | Items | Criteria | Result | Standard | |-----|--------------------------------------|------------------------------------------|---------------------------------------------------------------------------------|----------| | 1 | Visual | No impurities<br>and No specific changes | No impurities<br>and No specific changes | ISO 6872 | | 2 | Size | Size error of;<br>Standard Size < ±5% | (C-type) Size error of;<br>Standard Size < ±5%<br>W 0.03%, L 3.90%,<br>H 0.21% | ISO 6872 | | | | | (Disk type) Size error of;<br>Standard Size < ±5%<br>W 3.42%, L2.36%<br>H 0.07% | | | 3 | Package | No damage | No damage | ISO 6872 | | 4 | Uniformity | Uniform | Uniform | ISO 6872 | | 5 | Freedom from<br>extraneous materials | Not Freedom from<br>extraneous materials | Not Freedom from<br>extraneous materials | ISO 6872 | | 6 | Radioactivity | 238U Less than 1.0 Bq/g | 238U: < 0.00628Bq/g | ISO 6872 | | 7 | Chemical solubility | Less than 100 $ \mu $ g/cm² | Solubility: 12 $ \mu $ g/cm² | ISO 6872 | | 8 | Flexural strength | More than 100MPa | Average: 370MPa | ISO 6872 | {7}------------------------------------------------ Image /page/7/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. | | Linear thermal<br>expansion | $9.95(\pm0.5) X 10^{-6}K^{-1}$ | Average: $9.95 X 10^{-6}K^{-1}$ | ISO 6872 | |----|---------------------------------|--------------------------------|---------------------------------|----------| | 9 | | | | | | 10 | Glass-transition<br>temperature | Less than $579\pm20$ °C | 579 °C | ISO 6872 | All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the rainbow™ LS Block met the established specifications necessary for consistent performance according to its intended use. #### 7. Conclusion Based on the information provided in this premarket notification of GENOSS Co., Ltd. Concludes that rainbow™ LS Block is acceptable and substantially equivalent to predicate devices