(101 days)
rainbow™ Shade is a pre-sintered zirconia(Y-TZP) block for fabrication of single-tooth and bridgework restoration.
rainbow™ Shade is a dental ceramic made out of colored ZrO2(Y-TZP). rainbow™ Shade is milled into cores of teeth and then is fired in a furnace to harden the ZrO2. Then, the core is layered with porcelain to make a finished tooth.
The provided text describes the performance data for a dental ceramic device named "rainbow™ Shade." It includes acceptance criteria and results from various tests, primarily focusing on biocompatibility and physical properties.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
Here are the tables from the document, summarizing the acceptance criteria and the device's performance:
Biocompatibility Testing
| No. | Items | Criteria | Result | Standard |
|---|---|---|---|---|
| 1 | Cytotoxicity | None cytotoxicity | None cytotoxicity | ISO 10993-5 |
| 2 | Sensitization (Local Lymph Node Assay) | None sensitization | None sensitization | ISO 10993-10 |
| 3 | Oral mucosa irritation | Less than stimulus threshold | Minimal irritation | ISO 10993-10 |
| 4 | Acute systemic toxicity | None acute Systemic toxicity | None acute Systemic toxicity | ISO 10993-11 |
| 5 | Genotoxicity | None genotoxicity | None genotoxicity | ISO 10993-3 |
Performance Bench Testing
| No. | Items | Criteria | Result | Standard |
|---|---|---|---|---|
| 1 | Visual | No impurities and No specific changes | No impurities and No specific changes | ISO 6872 |
| 2 | Size | Size error of; Standard Size < ±5% | Size error of: Standard Size < ±5% H 0.43%, Ø 0.03% | ISO 6872 |
| 3 | Package | No damage | No damage | ISO 6872 |
| 4 | Uniformity | Uniform | Uniform | ISO 6872 |
| 5 | Freedom from extraneous materials | Not Freedom from extraneous materials | Not Freedom from extraneous materials | ISO 6872 |
| 6 | Radioactivity | 238U Less than 1.0 Bq/g | 238U: < 0.000124Bq/g 226Ra: < 0.010Bq/g | ISO 6872 |
| 7 | Chemical solubility | Less than 100 µg/cm² | Solubility: 0µg/cm² | ISO 6872 |
| 8 | Flexural strength | More than 800MPa | Average: 913MPa | ISO 6872 |
| 9 | Linear thermal expansion | 10.8(±0.5) X 10⁻⁶K⁻¹ | Average: 10.44 X 10⁻⁶K⁻¹ | ISO 6872 |
| 10 | Shipping Test | Result: Pass | Pass | ISTA2011 Integrity Test 3A |
Low Temperature Degradation Test
| No. | Items | Criteria | Result | Standard |
|---|---|---|---|---|
| 1 | Monoclinic phase fraction | Normal: Less than 20% after low temperature degradation: Less than 25% | Normal: 1.26% 134°C, 5 hours: 1.69% | ISO 6872 |
| 2 | Flexural strength | Less than 20% and more than 800MPa before/ after low temperature degradation | Normal: 850MPa 134°C, 5 hours: 832MPa | ISO 6872 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for any of the individual tests (e.g., number of specimens for flexural strength, number of animals for biocompatibility tests).
Data provenance: The submitter is GENOSS Co., Ltd. located in Gyeonggi-do, Korea. This suggests the testing was likely conducted in Korea or by a laboratory collaborating with the Korean company. The document does not specify if the studies were retrospective or prospective, but based on the nature of bench and biocompatibility testing for a new device submission, these would inherently be prospective studies performed to characterize the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the studies presented are primarily laboratory bench tests and biocompatibility tests, not studies requiring expert interpretation of medical images or clinical outcomes on patients. The "ground truth" for these tests is established by the test methodology and standards themselves (e.g., ISO 10993, ISO 6872).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reasons as point 3. No adjudication method is mentioned or implied for these types of tests. The results are quantitative measurements or qualitative observations by laboratory personnel following established protocols.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. The device "rainbow™ Shade" is a pre-sintered zirconia block for dental restorations, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness study was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. As stated above, this is a material science device, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance data presented is derived from established scientific and engineering standards and methodologies. For example:
- Biocompatibility tests: Ground truth is defined by the methodologies and interpretations outlined in the ISO 10993 series of standards (e.g., absence of cytotoxicity, sensitization, genotoxicity according to test methods).
- Physical and chemical property tests: Ground truth is based on the measurements obtained through standardized test procedures (e.g., ISO 6872 for dental ceramics) and compared against specified numerical criteria (e.g., flexural strength > 800MPa).
8. The sample size for the training set
This section is not applicable. The device is a physical material, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is rendered in black, and the text is also in black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 16, 2015
Genoss Co., Ltd. c/o Dachan Kwon iCT America. Inc. 180 Sylvan Avenue, 2nd Floor Englewood Cliffs, NJ 07632
Re: K151844
Trade/Device Name: Rainbow™ Shade Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: July 15, 2015 Received: July 22, 2015
Dear Dachan 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.
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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 5
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
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Indication for use
510(k) Number: K151844
rainbow™ Shade Device Name:
Indication for use:
rainbow™ Shade is a pre-sintered zirconia(Y-TZP) block for fabrication of single-tooth and bridgework restoration.
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
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Image /page/3/Picture/0 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 is simple and modern.
510(k) Summary
10/06/2015
1. Company
| Submitter | |
|---|---|
| Name | GENOSS Co., Ltd. |
| Address | 1F, Gyeonggi R&DB Center / 226, 2F, GSBC, 105Gwanggyo-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea |
| Phone/Fax | +82-31-888-5100/ +82-31-888-5105 |
| Contact person | Byungsun Kim / RAbskim@genoss.com |
| Summary Date | 10/06/2015 |
2. Device Name
Proprietary name: Regulation description : Porcelain powder for clinical use Classification name: Powder, porcelain
3. Predicated Device
K092513 RAINBOW BLOCK
4. Description
rainbow™ Shade is a dental ceramic made out of colored ZrO2(Y-TZP). rainbow™ Shade is milled into cores of teeth and then is fired in a furnace to harden the ZrO2. Then, the core is layered with porcelain to make a finished tooth.
5. Indication for use
rainbow™ Shade is a pre-sintered zirconia(Y-TZP) block for fabrication of single-tooth and bridgework restoration.
510(k) Summary
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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, while the last three letters, "OSS", are in a lighter green color. The font is bold and slightly italicized, giving the word a dynamic appearance. The overall design is simple and modern.
6. Technological Characteristics
rainbow™ Shade has the similar technological characteristics as the predicate device; main material, indication for use and design. Technological characteristics of rainbow™ Shade and RAINBOW BLOCK are as following
| Device name | rainbow™ Shade | RAINBOW BLOCK |
|---|---|---|
| Manufacturer | Genoss Co., Ltd. | Genoss Co., Ltd. |
| 510(k) Number | New Device | K092513 |
| Materials | ZrO2(Y-TZP) | ZrO2(Y-TZP) |
| Form | Preformed block | Preformed block |
| Sterilization | Non-sterile | Non-sterile |
| Indication for use | rainbow™ Shade is a pre-sinteredzirconia(Y-TZP) block forfabrication of single-tooth andbridgework restoration. | Rainbow Block is used in themanufacture of a dental core throughmilling by machine (MAD/MAM orCAD/CAM) followed by sintering. |
| Use | Prescription | Prescription |
| Properties | ||
| Bending Strength(Flexural strength) | 913MPa | 1144MPa |
| Sintering Density(g/cm³) | 6 | 6.00~6.04 |
| Radioactivity(Bq/kg) | 0.01 | 0.01 |
| Chemical Solubility(µg/cm²) | 22.65 | 14.47 |
| Biocompatibility | Biocompatible | Biocompatible |
The differences of 'Indication for use' are not critical to the intended use. The general intended use of zirconia blank is to manufacture a dental prosthesis using milling machine. The dental core means single or bridgework restoration.
And the differences of technological characteristics(bending strength, chemical solubility) are within what is expected of this type of device.
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Image /page/5/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The first four letters, "GENO", are in a dark green color. The last three letters, "OSS", are in a lighter green color.
7. Performance Data
Biocompatibility testing on the proposed rainbow™ Shade 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(Local Lymph Node Assay) | None sensitization | None sensitization | ISO 10993-10 |
| 3 | Oral mucosa irritation | Less than stimulusthreshold | Minimal irritation | ISO 10993-10 |
| 4 | Acute systemic toxicity | None acute Systemictoxicity | None acute Systemictoxicity | ISO 10993-11 |
| 5 | Genotoxicity | None genotoxicity | None genotoxicity | ISO 10993-3 |
| ISO 10993-3 |
The proposed rainbow™ Shade was evaluated using the following performance bench testing to confirm the performance characteristics:
| No. | Items | Criteria | Result | Standard |
|---|---|---|---|---|
| 1 | Visual | No impuritiesand No specific changes | No impuritiesand No specific changes | ISO 6872 |
| 2 | Size | Size error of;Standard Size < ±5% | Size error of:Standard Size < ±5%H 0.43%, Ø 0.03% | ISO 6872 |
| 3 | Package | No damage | No damage | ISO 6872 |
| 4 | Uniformity | Uniform | Uniform | ISO 6872 |
| 5 | Freedom fromextraneous materials | Not Freedom fromextraneous materials | Not Freedom fromextraneous materials | ISO 6872 |
| 6 | Radioactivity | 238U Less than 1.0 Bq/g | 238U: < 0.000124Bq/g226Ra: < 0.010Bq/g | ISO 6872 |
| 7 | Chemical solubility | Less than 100 µg/cm² | Solubility: 0µg/cm² | ISO 6872 |
| 8 | Flexural strength | More than 800MPa | Average: 913MPa | ISO 6872 |
| 9 | Linear thermalexpansion | 10.8(±0.5) X 10⁻⁶K⁻¹ | Average: 10.44 X 10⁻⁶K⁻¹ | ISO 6872 |
| 10 | Shipping Test | Result: Pass | Pass | ISTA2011Integrity Test 3A |
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| Low Temperature degradation test | ||||
|---|---|---|---|---|
| 1 | Monoclinic phase fraction | Normal: Less than 20% after low temperature degradation: Less than 25% | Normal: 1.26%134°C, 5 hours: 1.69% | ISO 6872 |
| 2 | Flexural strength | Less than 20% and more than 800MPa before/ after low temperature degradation | Normal: 850MPa134°C, 5 hours: 832MPa | ISO 6872 |
All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the rainbow™ Shade 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™ Shade is substantially equivalent to the predicate device.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.