(301 days)
rainbow™ Shine is used in the manufacture of a dental core through milling by machine (MAD/ MAM or CAD/CAM) followed by sintering.
rainbow™ Shine is a partially sintered dental ceramic made out of colored ZrO2(Y-TZP). These blanks are fabricated into dental core (zirconia substructure) of crowns and bridges. The core can be used as final prosthesis by itself or can be layered with porcelain. rainbow™ Shine is fabricated by CAD/CAM or MAD/MAM machining processes. At the dental lab, the blanks are held to the milling machine which is used to machine to the final dental restoration. After machining steps, the dental restoration is fully sintered in the furnace to harden the ZrO2. and fitted to the patients as crowns and bridges. rainbow™ Shine is available in numerous shapes and sizes in order to be compatible with multiple milling machines. According to the shapes, they are used for fabricating of each intended dental restoration, such as single crowns, bridges including from 2-bridge to 16bridge(full arch). It is also supplied in six different colors (A0, A0.5, A1, A2, A3, A4) for each shapes. rainbow™ Shine is not for use or intended for use to fabricate the top-half of an abutment/titanium base and is for the fabrication of dental restorations only.
This document is a 510(k) summary for the rainbow™ Shine dental ceramic. The document asserts the device's substantial equivalence to a predicate device based on non-clinical testing.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (ISO 6872:2008) | Reported Device Performance (rainbow™ Shine) | Reported Predicate Performance (rainbow™ High Shine) | Comparison to Acceptance Criteria |
|---|---|---|---|---|
| Bending Strength (Flexural Strength) | > 500 MPa (for Class 5 dental ceramics) | 865 MPa | 706 MPa | Meets and exceeds |
| Sintering Density | (Not explicitly stated in document, but "Same" for both devices implies meeting a standard) | 6 g/cm³ | 6 g/cm³ | Assumed to meet |
| Radioactivity | < 1.0 (Bq/g) | < 1.0 Bq/g | < 1.0 Bq/g | Meets |
| Linear thermal expansion (10⁻⁶ K⁻¹) | (Not explicitly stated in document, but "Same" for both devices implies meeting a standard) | 10.4 (±0.5) | 10.4 (±0.5) | Assumed to meet |
| Chemical Solubility | < 100 µg/cm² (for Class 6 dental ceramics, though rainbow™ Shine is Class 5. This appears to be a slight discrepancy in the document's wording but implies a stringent standard) | 0 µg/cm² | 3 µg/cm² | Meets and exceeds |
| Biocompatibility | ISO 10993-1:2009 standards (Cytotoxicity, Irritation, Sensitization, Acute systemic toxicity, Genotoxicity) | Biocompatible | Biocompatible | Meets |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the non-clinical tests (bending strength, chemical solubility, etc.). It only mentions that "Non-clinical device testing was conducted to confirm the performance of the subject device" and "Bench tests for performance comparison...includes the following testing." The data provenance is not specified, but since Genoss Co., Ltd. is based in Korea and the submission is to the FDA, it is likely the testing was conducted in a laboratory setting, potentially in Korea or by a contracted lab. The study is retrospective in nature, presenting the results of pre-market testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The tests described are non-clinical, benchtop tests (e.g., material property measurements) and biocompatibility assessments, which are performed in a laboratory settings and do not directly involve human experts in establishing a "ground truth" for clinical outcomes in the same way an imaging study might. The "ground truth" for these tests are the established scientific and engineering principles and the recognized consensus standards (like ISO 6872:2008 and ISO 10993-1:2009).
4. Adjudication Method for the Test Set
This information is not applicable as the tests described are non-clinical and do not involve human interpretation or subjective assessment that would require an adjudication method.
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
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a dental ceramic block, not an AI-powered diagnostic or assistive technology. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a material, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests (bending strength, chemical solubility, etc.), the "ground truth" is defined by the recognized consensus standards, specifically ISO 6872:2008 (Dentistry - Ceramic materials) and ISO 10993-1:2009 (Biological evaluation of medical device - Part 1: Evaluation and testing within a risk management process). These standards define the methods for testing and the acceptable ranges for the performance characteristics of dental ceramic materials.
8. The Sample Size for the Training Set
This information is not applicable. This device is a dental ceramic and does not involve machine learning or AI, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract design of three human profiles facing to the right, with flowing lines extending from the heads. The design is meant to symbolize the department's mission of promoting the health and well-being of the people.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 10, 2016
Genoss Co. Ltd. Byungsun Kim Official Correspondent 1f Gyeonggi R&DB Center/226, 2f, GSBC 105Gwanggyo-ro Yeongton-gu Suwon-si, KR 443-270 Gyeonggi-do
Re: K160079
Trade/Device Name: rainbow™ Shine Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: October 7, 2016 Received: October 11, 2016
Dear Byungsun Kim:
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
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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,
Susan Runyan DDS, MA
Tina Kiang, Ph.D. Acting 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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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, and the letters are slightly slanted to the right.
Indication For Use
510(k) Number: K160079
rainbow™ Shine Device Name:
Indication for use:
rainbow™ Shine is used in the manufacture of a dental core through milling by machine (MAD/ MAM or CAD/CAM) followed by sintering.
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 letters "OSS" are connected in a stylized way.
510(k) Summary
11/07/2016
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 | 11/07/2016 |
2. Device Name
| Proprietary name | : rainbow™ Shine |
|---|---|
| Regulation number | : 21 CFR 872.6660 |
| Classification name | : Porcelain powder for clinical use |
| Product code | : EIH |
| Device class | : Class II |
3. Predicate Device
K151842 rainbow™ High Shine
4. Description
rainbow™ Shine is a partially sintered dental ceramic made out of colored ZrO2(Y-TZP). These blanks are fabricated into dental core (zirconia substructure) of crowns and bridges. The core can be used as final prosthesis by itself or can be layered with porcelain.
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Image /page/4/Picture/0 description: The image shows the word "GENOSS" in green font. The first four letters, "GENO", are in a darker green, while the last three letters, "OSS", are in a lighter green. The letters are all capitalized and appear to be part of a logo.
rainbow 104 Shine is fabricated by CAD/CAM or MAD/MAM machining processes. At the dental lab, the blanks are held to the milling machine which is used to machine to the final dental restoration. After machining steps, the dental restoration is fully sintered in the furnace to harden the ZrO2. and fitted to the patients as crowns and bridges.
rainbow™ Shine is available in numerous shapes and sizes in order to be compatible with multiple milling machines. According to the shapes, they are used for fabricating of each intended dental restoration, such as single crowns, bridges including from 2-bridge to 16bridge(full arch). It is also supplied in six different colors (A0, A0.5, A1, A2, A3, A4) for each shapes.
rainbow™ Shine is not for use or intended for use to fabricate the top-half of an abutment/titanium base and is for the fabrication of dental restorations only.
5. Indication for use
rainbow™ Shine is used in the manufacture of a dental core through milling by machine (MAD/ MAM or CAD/CAM) followed by sintering.
6. Technological Characteristics
The following comparison table of the technological characteristics of the subject device and the predicate devices outlines and provides the similarities and the substantial equivalency of the rainbow™ Shine and the predicate.
Comparison of Characteristics
| Device name | rainbowTM Shine | rainbowTM High Shine | Comparison |
|---|---|---|---|
| Manufacturer | Genoss Co., Ltd. | Genoss Co., Ltd. | Same |
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Image /page/5/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 bold and have a slightly rounded appearance.
510(K) Number: K160079
| 510(k) Number | K160079 | K151842 | - |
|---|---|---|---|
| Materials | ZrO₂(Y-TZP) | ZrO₂(Y-TZP) | Same |
| Form | Preformed block | Preformed block | Same |
| Type, class ofdental ceramic | Type II - Class 5 | Type II - Class 5 | Same |
| Sterilization | Non-sterile | Non-sterile | Same |
| Indication foruse | rainbow™ Shine is used inthe manufacture of a dentalcore through milling bymachine (MAD/ MAM orCAD/CAM) followed bysintering. | rainbow™ High Shine isused in the manufacture of adental core through millingby machine (MAD/ MAMor CAD/CAM) followed bysintering. | Same |
| Principle ofoperations | rainbow™ Shine is apartially sintered zirconiablock. To make dentalprosthesis, rainbow™ Shineis processed by millingmachine(CAD/CAM orMAD/ MAM) and is finallysintered. | rainbow™ High Shine is apartially sintered zirconiablock. To make dentalprosthesis, rainbow™ HighShine is processed bymillingmachine(CAD/CAM orMAD/ MAM) and is finallysintered. | Same |
| Use | Prescription | Prescription | Same |
| Technical characteristics | |||
| BendingStrength(Flexuralstrength) | 865MPa | 706MPa | Bending strength ishigher than required byISO 6872:2008 forClass 5 dental ceramics.( > 500 Mpa ) |
| Sintering Density(g/cm³) | 6 | 6 | Same |
| Radioactivity(Bq/g) | < 1.0 | < 1.0 | Same |
| Linear thermalexpansion (10⁻⁶K⁻¹) | 10.4(±0.5) | 10.4(±0.5) | Same |
| ChemicalSolubility(µg/cm²) | 0 | 3 | Chemical solubilitysatisfies requirement byISO 6872:2008 forClass 6 dental ceramics.(< 100 µg/cm²) |
| Biocompatibility | Biocompatible | Biocompatible | Same |
| Shape | Single | Image: Cylinder with diameter and height labeled | Same |
| Diameter 25mmHeight 12, 16, 22mm |
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GENOSS
510(K) Number: K160079
| Shape | 2~9bridge | Image: [Image of a rectangular prism with labeled dimensions D, W, and H]Diameter 44.5~75.5mmWidth 25.5, 25, 26, 38mmHeight 12, 16, 22mm | |
|---|---|---|---|
| 10~16bridge | Image: [Image of a half-cylinder prism with labeled dimensions D, W, and H]Diameter 89, 95mmWidth 55, 75mmHeight 12, 16, 22mm | Same | |
| Disk | Image: [Image of a cylinder with labeled dimensions Ø and H]Diameter 87, 95, 98, 100mmHeight 10~28mm | ||
| Stepblock | Image: [Image of a stepped cylinder with labeled dimensions]Diameter 95mmHeight 10~28mm |
510(k) Summary
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510(K) Number: K160079
Image /page/7/Picture/2 description: The image shows a white, circular object. Text below the object indicates that it has a diameter of 98mm and a height between 10 and 28mm. There are also two lines with numbers 1 and 2 pointing to the diameter of the object.
There is a minor difference that is worth discussing:
- The differences of technological charcteristics(Bending strength, chemical solubility) are within what is expected of this type of device. The rainbow High Shine has a lower bending strength than the predicate device, due to the fact that the material is completely stabilized with Y-Ox in order to achieve higher translucency. However, the performance test results satisfy the requirement by ISO 6872:2008
7. Summary of non-clinical testing
Non-clinical device testing was conducted to confirm the performance of the subject device. Testing was conducted in accordance with the FDA recognized consensus standard(Recognition number : 4-178: ISO 6872 Third edition 2008-09-01, dentistry - ceramic materials) Bench tests for performance comparison of the subject device and the predicate device includes the following testing:
| - Bending Strength | - Linear thermal expansion coefficient |
|---|---|
| - Chemical Solubility | - Radioactivity |
Technical characteristics of both devices satisfy the requirements by ISO 6872:2008. The slight differences between the subject and predicate devices do not raise any new issues.
Biocompatibility testing was conducted on the device pursuant to the ISO 10993-1:2009 Biological evaluation of medical device - Part 1: Evaluation and testing within a risk management process.
510(k) Summary
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Image /page/8/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 bold and sans-serif, and the letters are connected to each other.
- Cytotoxicity test(ISO 10993-5)
- Irritation or intracutaneous reactivity(ISO 10993-10)
- Sensitization(ISO 10993-10)
- Acute systemic toxicity(ISO 10993-11)
- Genotoxocity(ISO 10993-03)
The result of biocompatibility testing demonstrated that no issue of biocompatibility arises.
8. Conclusion
Based on the information provided in this premarket notification of GENOSS Co., Ltd. Concludes that rainbow™ Shine 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.