(191 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). rainbow™ Shine 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.
The provided document is a 510(k) summary for a dental ceramic device named "rainbow™ Shine". It details the device's characteristics and compares it to a predicate device, "RAINBOW BLOCK", to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate RAINBOW BLOCK / ISO 6872:2008) | Reported Device Performance (rainbow™ Shine) | Comparison Status / Notes |
|---|---|---|---|
| Device Classification | Type II - Class 6 (for predicate) | Type II - Class 5 | The subject device and predicate device satisfy dental ceramic classification requirements by ISO 6872:2008. The difference in class and bending strength is noted, with rainbow™ Shine having a lower bending strength due to complete Y2O3 stabilization for higher translucency. Despite this, it meets the ISO standard. |
| Bending Strength (Flexural strength) | 1144 MPa (for predicate) / > 500 MPa (ISO 6872:2008 for Class 5) | 706 MPa | Bending strength for rainbow™ Shine is higher than required by ISO 6872:2008 for Class 5 dental ceramics (> 500 MPa), despite being lower than the predicate. |
| Sintering Density (g/cm³) | 6.00-6.04 (for predicate) | 6 | Same (within range of predicate and likely meets ISO, though specific ISO density not stated) |
| Radioactivity (Bq/g) | < 1.0 Bq/g (for predicate) | < 1.0 Bq/g | Same |
| Chemical Solubility (µg/cm²) | 14.47 (for predicate) / < 2000 µg/cm² (ISO 6872:2008 for Class 5) | 3 | Chemical solubility for rainbow™ Shine satisfies the requirement by ISO 6872:2008 for Class 5 dental ceramics (< 2000 µg/cm²), and is lower/better than the predicate. |
| Biocompatibility | Biocompatible (for predicate) | Biocompatible | Same, confirmed by ISO 10993 testing. |
| Materials | Tosoh Powder (for predicate) | Tosoh Powder | Same base material, with slight differences in Y2O3 percentages and trace elements (SiO2, Fe2O3, Na2O, Er2O3) used as colorants, which reportedly have no material effects on biocompatibility. |
| Form | Preformed block (for predicate) | Preformed block | Same |
| Sterilization | Non-sterile (for predicate) | Non-sterile | Same |
| Indication for use | As described for predicate | As described for subject device | Same |
| Use | Prescription (for predicate) | Prescription | Same |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for the non-clinical bench tests (bending strength, sintering density, radioactivity, chemical solubility). It only states that "Non-clinical device testing was conducted to confirm the performance of the subject device." The data provenance is implied to be from the manufacturer (GENOSS Co., Ltd.) through their conducted tests, but the country of origin of the testing facilities or whether the data is retrospective or prospective is not explicitly stated.
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. The ground truth for the performance criteria is established by recognized standards (ISO 6872:2008), not through expert consensus on individual cases.
4. Adjudication method for the test set
Not applicable. The tests are bench tests against a recognized standard, not clinical studies requiring adjudication of diagnostic outcomes.
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
Not applicable. This is a material science and biocompatibility assessment of a medical device (dental ceramic), not an AI-powered diagnostic tool. Therefore, an MRMC study related to human readers and 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 not an algorithm. The "standalone" performance here relates to the inherent material properties and biocompatibility of the ceramic block itself, which were tested via bench and biocompatibility tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for evaluating the device's performance is:
- Recognized consensus standards: Specifically, ISO 6872:2008 (dentistry - ceramic materials) for physical properties like bending strength and chemical solubility, and ISO 10993-1:2009 (Biological evaluation of medical device) for biocompatibility.
- Comparison to a legally marketed predicate device: The characteristics of the RAINBOW BLOCK predicate device also serve as a reference for comparison.
8. The sample size for the training set
Not applicable. This is not a machine learning model, so there is no concept of a "training set" in the context of this device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device. The "ground truth" for the device's properties is established through standardized testing methodologies as defined by ISO standards.
{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 depiction of a human figure, represented by three overlapping profiles facing to the right. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 14, 2016
GENOSS Co., Ltd. c/o Mr. Dachan Kwon iCT America, Inc. 180 Sylvan Avenue, 2nd Floor Englewood Cliffs, New Jersey 07632
Re: K15842
Trade/Device Name: rainbow™ Shine Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: December 7, 2015 Received: December 9, 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 device-related 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.
Tina
Kiang -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 "GEN" are solid black, while the letters "OSS" appear to be composed of a textured, almost grainy pattern. The overall effect gives the word a dynamic and somewhat distressed appearance.
Indication for use
к151842 510(k) Number:
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 __ V (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
Page 1 of 1
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for GENOSS. The word "GEN" is in dark green, and the word "OSS" is in light green. The letters are all capitalized and in a sans-serif font. The logo is simple and modern.
510(k) Summary
12/07/2015
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 | 12/07/2015 |
2. Device Name
| Proprietary name | : rainbowTM Shine |
|---|---|
| Regulation number | : 21 CFR 872.6660 |
| Classification name | : Porcelain powder for clinical use |
| Product code | : EIH |
| Device class | : Class II |
3. Predicated Device
K092513 RAINBOW BLOCK
4. Description
rainbow™ Shine is a partially sintered dental ceramic made out of colored ZrO2(Y-TZP). rainbow™ Shine 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}------------------------------------------------
510(K) Number: K151842
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 "SS" are in a lighter green color. The font is sans-serif and has a modern look.
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.
| Device name | rainbowTM Shine | RAINBOW BLOCK | Comparison |
|---|---|---|---|
| Manufacturer | Genoss Co., Ltd. | Genoss Co., Ltd. | Same |
| 510(k) Number | New Device | K092513 | - |
| Materials | Tosoh Powder | Tosoh Powder | Same |
| Form | Preformed block | Preformed block | Same |
| Type, class ofdental ceramic | Type II - Class 5 | Type II - Class 6 | The subject and predicatedevices satisfy dentalceramic classificationrequirement byISO 6872:2008 |
| Sterilization | Non-sterile | Non-sterile | Same |
| Indication foruse | rainbowTM Shine is used inthe manufacture of a dentalcore through milling bymachine (MAD/ MAM orCAD/CAM) followed bysintering. | Rainbow Block is used inthe manufacture of a dentalcore through milling bymachine (MAD/MAM orCAD/CAM) followed bysintering. | Same |
| Use | Prescription | Prescription | Same |
| Technical characteristics | |||
| BendingStrength(Flexuralstrength) | 706MPa | 1144MPa | Bending strength ishigher than required byISO 6872:2008 forClass 5 dental ceramics.( > 500 Mpa ) |
| Sintering Density(g/cm3) | 6 | 6.00~6.04 | Same |
| Radioactivity(Bq/g) | < 1.0 Bq/g | < 1.0 Bq/g | Same |
| ChemicalSolubility(µg/cm²) | 3 | 14.47 | Chemical solubilitysatisfies requirement byISO 6872:2008 forClass 5 dental ceramics.(< 2000 µg/cm²) |
| Biocompatibility | Biocompatible | Biocompatible | Same |
| Shape | SingleImage: Single cylinder with diameter and height labeled | Image: Single cylinder | SimilarThe subject and predicate |
| 2~9bridgeImage: Rectangular prism with width, depth, and height labeled | Image: Rectangular prism | ||
| 10~16bridgeImage: Curved shape with width, depth, and height labeled | Image: Curved shape | devices are available innumerous shapes and sizesin order to be compatiblewith multiple millingmachines. | |
| DiskImage: Disk with diameter and height labeled | Image: Disk |
Comparison of Characteristics
{5}------------------------------------------------
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 font is sans-serif and has a modern look.
510(K) Number: K151842
{6}------------------------------------------------
510(K) Number: K151842
Image /page/6/Figure/2 description: The image shows a table with three rows and three columns. The first column is labeled "Shape" and contains the text "Step block". The second column contains images of white, cylindrical objects with varying diameters and heights, specifically diameters of 95mm and 98mm, and heights ranging from 10mm to 28mm. The third column is mostly empty, with only a dash in the last row.
There are two minor differences that are worth discussing:
-
- The subject and predicate device have slight difference in materials. The ZrO2 and Y2O3 are major materials of general zirconia blank. The differences in the composition between the subject and predicate device relate to the percentages of Y2O3 and they have effect on the crystal structure and consequently on the translucency of the device. SiO2, Fe2O3, Na2O and Er2O3 are trace elements used as colorants, but they have no material effects on the biocompatibility of the device. The non-clinical tests(bench test and biocompatibility test) demonstrate the Technical characteristics.
-
- The differences of technological characteristics(Bending strength, chemical solubility) are within what is expected of this type of device. The rainbow Shine has a lower bending strength than the predicate device, due to the fact that the material is completely stabilized with Y2O3 in order to achieve higher translucency. However, the performance test results satisfy the requirement by ISO 6872:2008
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for GENOSS. The word "GENOSS" is written in a sans-serif font. The letters "GENO" are in a dark green color, while the letters "SS" are in a lighter green color. The logo is simple and modern.
7. Summary of non-clinical testing
Non-clinical device testing was conducted to confirm the performance of the subject device. Bench 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
Technical characteristics of both devices satisfy the requirements by ISO 6872:2008. Slight differences between the subject and predicate devices do not raise any new issues of safety and effectiveness.
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.
- 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.