Rainbow Trans

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 28, 2015 Genoss c/o Mr. Dachan Kwon iCT America, Inc. 180 Sylvan Avenue, 2nd Floor Englewood Cliffs, New Jersey 07632 Re: K151723 Trade/Device Name: rainbow™ Trans Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: September 21, 2015 Received: September 23, 2015 #### Dear Mr. Kwon: 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. {1}------------------------------------------------ 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 the quality systems (QS) 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, Tina Kiang 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 shade. The font appears to be bold and sans-serif, with a slightly rounded design. # Indication for use 510(k) Number: k151723 rainbow™ Trans Device Name: rainbow™ Trans is used in the manufacture of a dental core. Indication for use: 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/1 description: The image shows the word "GENOSS" in a stylized font. The "GEN" part of the word is in a dark green color, while the "OSS" part is in a lighter green color. The font is sans-serif and has a modern look. # 510(K) Summary #### 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 | +82-70-7098-8806/ +82-31-888-5595 | | Contact person | Byungsun Kim / RA<br>bskim@genoss.com | | Summary Date | 10/16/2015 | ## 2. Device Identification | Proprietary name | : | rainbow™ Trans | |---------------------|---|-----------------------------------| | Regulation number | : | 21 CFR 872.6660 | | Classification name | : | Porcelain powder for clinical use | | Product code | : | EIH | | Device class | : | Class II | #### 3. Predicate Device | K092513 | Predicate | |---------|-----------| | K093560 | Reference | #### 4. Description rainbow™ Trans is a partially sintered dental ceramic made out of colored ZrO2(Y-TZP). rainbow™ Trans is milled into cores of artificial teeth and then is finally sintered in a furnace to harden the ZrO2. Then, the core is layered with porcelain to make a finished tooth. {4}------------------------------------------------ Image /page/4/Picture/1 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 sans-serif and has a modern look. #### 5. Indication for use rainbow™ Trans is used in the manufacture of a dental core. ## 6. Comparison of Technological Characteristics rainbow™ Trans has the similar technological characteristics as the predicate device; main material, indication for use and design. Technological characteristics of rainbow™ Trans, RAINBOW BLOCK, Upcera Zirconia Blanks are as following | Device name | rainbowTM Trans | RAINBOW BLOCK | Upcera Zirconia Blanks | |-----------------------------------------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Genoss Co., Ltd. | Genoss Co., Ltd. | Shenyang Upcera Co., Ltd. | | 510(k) Number | New Device | K092513 | K093560 | | Materials | ZrO2(3Y-TZP*)<br>* 3Y-TZP : 3mol% Yttria Tetragonal<br>Zirconia Polycrystal | ZrO2(3Y-TZP*) | ZrO2(3Y-TZP*) | | Form | Preformed block | Preformed block | Preformed block | | Sterilization | Non-sterile | Non-sterile | Non-sterile | | Indication for use | rainbowTM Trans is used in<br>the manufacture of a dental<br>core. | Rainbow Block is used in<br>the manufacture of a<br>dental core through<br>milling by machine<br>(MAD/MAM or<br>CAD/CAM) followed by<br>sintering. | Upcera Zirconia<br>Blanks are intended for<br>use in the production<br>of artificial teeth in fixed<br>or removable dentures,<br>or for jacket crowns,<br>facings, and veneers. | | Use | Prescription | Prescription | Prescription | | Properties | | | | | Bending Strength<br>(Flexural strength) | 902MPa | 1144MPa | 1200MPa | | Sintering Density<br>(g/cm3) | 6.00~6.04 | 6.00~6.04 | 6 | | Radioactivity<br>(Bq/g) | 0.01 | 0.01 | 0.015 | | Chemical Solubility<br>(µg/cm²) | 9 | 14.47 | 17.00 | | Biocompatibility | Biocompatible | Biocompatible | Biocompatible | The Indication for use and material of subject device and predicate device are equivalent. And the differences of technological characteristics(Flexural strength, chemical solubility) are within what is expected of this type of device. According to the standard ISO 6872:2008, both #### 510(k) Summary {5}------------------------------------------------ Image /page/5/Picture/1 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 sans-serif and has a modern look. subject device and predicate device are classified as Type II Class 6 dental ceramic indicated for prostheses involving four or more units, and both devices satisfy the mechanical and chemical properties(Flexural strength: ≥ 800MPa, Chemical solubility: ≤ 100ug/cm²). Therefore, the subject device is substantially equivalent to the predicate devices. ## 7. Performance Data Biocompatibility testing on the proposed rainbow™ Trans 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: | 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 | None genotoxicity | None genotoxicity | ISO 10993-3 | The proposed rainbow™ Trans 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% | Size error of;<br>Standard Size < ±5% | ISO 6872 | | 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: < 0.000124Bq/g<br>226Ra: < 0.010Bq/g | ISO 6872 | | 7 | Chemical solubility | Less than 100 µg/cm2 | Solubility: 9µg/cm2 | ISO 6872 | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for GENOSS. The word "GENOSS" is written in a sans-serif font. The letters "GEN" are in a dark green color, while the letters "OSS" are in a lighter green color. The logo has a modern and clean design. | 8 | Flexural strength | More than 800MPa | Average: 902MPa | ISO 6872 | |----|-----------------------------|------------------------------|---------------------------------|-------------------------------| | 9 | Linear thermal<br>expansion | $10.8(±0.5) X 10^{-6}K^{-1}$ | Average: $10.8 X 10^{-6}K^{-1}$ | ISO 6872 | | 10 | Shipping Test | Result: Pass | Pass | ISTA2011<br>Integrity Test 3A | All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the rainbow™ Trans met the established specifications necessary for consistent performance according to its intended use. #### 8. Conclusion The information provided in this premarket notification from GENOSS Co., Ltd. supports the conclusion that rainbow™ Trans is substantially equivalent to the predicate devices