(217 days)
rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono is used in the manufacture of a dental core through milling by machine followed by sintering.
rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is a partially sintered dental ceramic made out of colored ZrO2(Y-TZP). rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is milled into core (zirconia substructure) of artificial teeth and then is finally sintered in a furnace to harden the ZrO2.
rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono 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™ Multi-Layer Block / bright 3-Layer / bright Mono 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 anterior crowns, posterior crowns, bridges
rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono 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.
The provided text describes the 510(k) premarket notification for the "rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono" dental ceramic. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a legally marketed predicate device.
The information provided in the document focuses on the bench testing and biocompatibility testing performed on the device to establish its safety and performance characteristics, comparing it to a predicate device. It does not present a study related to AI or human reader performance/improvement, nor does it describe a ground truth establishment process involving experts or pathology for a test set. This is because the device is a dental material (porcelain powder for clinical use), not an AI-powered diagnostic or assistive tool.
Therefore, for the aspects related to AI/human reader studies, ground truth establishment, or MRMC studies, the requested information is not applicable to this specific device and the provided document.
Here's the breakdown of the information that is available in the document, framed by the acceptance criteria provided in your prompt, and noting where the requested information is not relevant to this type of device submission:
Device: rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono (Dental Ceramic)
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details various performance tests, primarily mechanical and chemical, with their acceptance criteria and results.
| No. | Test Item | Acceptance Criteria (Bench Test) | Reported Device Performance (Result) |
|---|---|---|---|
| 1 | Visual | No impurities and No specific changes | Met established specifications |
| 2 | Size | Standard weight <±5% | Met established specifications |
| 3 | Package | No damage | Met established specifications |
| 4 | Uniformity | Uniform after sintering | Met established specifications |
| 5 | Freedom from extraneous materials | Free from extraneous materials | Met established specifications |
| 6 | Radioactivity | 238U Less than 1.0 Bq/g | < 1.0 Bq/g (also listed as < 1.0 in comparison table) |
| 7 | Flexural strength | More than 500 MPa | 807.1 MPa (comparison table) / Also "Met established specifications" |
| 8 | Linear thermal expansion | (10.7 ± 0.5) X 10^-6^ K^-1^ | 10.7 (comparison table) / Also "Met established specifications" |
| 9 | Chemical Solubility | Less than 100 µg/cm^2^ | 28.8 µg/cm^2^ (comparison table) / Also "Met established specifications" |
| Biocompatibility Tests | |||
| 1 | Cytotoxicity | None cytotoxicity | Pass |
| 2 | Sensitization | None sensitization | Pass |
| 3 | Irritation or intracutaneous reactivity | None irritation | Pass |
| 4 | Systemic toxicity (acute) | None systemic toxicity | Pass |
| 5 | Genotoxicity | No Toxicity | Pass |
| 6 | Subchronic toxicity | No Toxicity | Pass |
| 7 | Implantation | No Toxicity | Pass |
| 8 | Chronic toxicity | No Toxicity | Pass |
| 9 | Carcinogenicity | No Toxicity | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The exact sample size for each bench test (e.g., number of blocks tested for flexural strength) is not explicitly stated in the summary document. It states that "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono met the established specifications."
- Data Provenance: The tests were conducted to support a submission to the U.S. FDA by Genoss Co., Ltd. from South Korea. The type of data is bench test data and biocompatibility test data, performed on the device material itself. This is not a human clinical study in the sense of retrospective or prospective patient data, but rather laboratory testing of a material.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. As this is a dental material, the "ground truth" for its performance is established through standardized laboratory testing (e.g., ISO 6872 for dental ceramics, ISO 10993 for biocompatibility) and direct physical/chemical measurements by qualified lab personnel. There is no concept of "experts establishing ground truth" in the diagnostic imaging sense for this device.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods are relevant for studies involving human interpretation (e.g., radiologists reviewing images). For physical and chemical material testing, the results are typically quantitative measurements or qualitative observations by laboratory technicians/scientists following established protocols, not subjective assessment requiring adjudication.
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 dental ceramic block, not an AI-powered device or software. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. Again, this is a physical dental material, not an algorithm or software. As such, the concept of "standalone algorithm performance" does not apply. The device's "performance" is its material properties and safety.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established by international standards (e.g., ISO 6872 for dental ceramics, ISO 10993 for biological evaluation of medical devices). These standards define the accepted methodologies and criteria for testing the material's physical, chemical, and biological properties. The results of these tests, conducted according to the standards, serve as the evidence of the device's performance and safety.
8. The Sample Size for the Training Set
- Not Applicable. As this is a physical medical device (dental ceramic) and not an AI/Machine Learning model, there is no concept of a "training set" in the computational sense. The product development and manufacturing process involve R&D and quality control, but not data-driven machine learning training.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. There is no "training set" for this device, as it is not an AI/ML product.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 23, 2024
Genoss Co., Ltd. Hayoung Sung Staff 1F, 106, Jeongoksandan-ro, Seosin-myeon Hwaseong-si, Gyeonggi-do 16229 Korea. South
Re: K232174
Trade/Device Name: rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: January 23, 2024 Received: January 23, 2024
Dear Hayoung Sung:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software
Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bobak Shirmohammadi -S
For Michael E. Adiodha. M. ChE., RAC, COIA Assistant Director DHT1B: Division of Dental and
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ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono
Indications for Use (Describe)
rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono is used in the manufacture of a dental core through milling by machine followed by sintering
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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 letters are bold and have a rounded appearance.
510(k) Summary-K232174
02/22/2024
1. Company
| Submitter | |
|---|---|
| Name | GENOSS Co., Ltd. |
| Address | Head Office : 12F, 76, Changnyong-daero 256beon-gil, Yeontong-gu,Suwon-si, Gyeonggi-do, Republic of KoreaManufacturing site : 106, Jeongoksandan-ro, Seosin-myeon, Hwaseong-si,Gyeonggi-do, Republic of Korea |
| Phone/Fax | +82-70-7098-8920/ +82-31-888-5105 |
| Contact person | Hayoung Sung / RAhysung@genoss.com |
| Summary Date | 29/06/2023 |
2. Device Name
| Proprietary name: | rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono |
|---|---|
| Regulation description: | Porcelain Powder for clinical use |
| Classification name: | Powder, Porcelain |
| Regulation Number: | 21 CFR 872.6660 |
| Regulation Code: | EIH |
| Regulation Class: | Class II |
3. Predicate Device
rainbow™ Shine
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Image /page/5/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 letters are connected to each other, and the overall design is modern and sleek.
4. Description
rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is a partially sintered dental ceramic made out of colored ZrO2(Y-TZP). rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is milled into core (zirconia substructure) of artificial teeth and then is finally sintered in a furnace to harden the ZrO2.
rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono 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™ Multi-Layer Block / bright 3-Layer / bright Mono 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 anterior crowns, posterior crowns, bridges
rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono 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™ Multi-Layer Block / bright 3-Layer / bright Mono is used in the manufacture of a dental core through milling by machine followed by sintering.
6. Technological Characteristics
rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono was compared with the predicate device 'rainbow™ Shine' in clinical, technical, biological view. The characteristics that differed from the predicate device were performed by gap analysis, which confirmed equivalence with the predicate device. Technological characteristics rainbow™M Multi-Layer
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Image /page/6/Picture/0 description: The image shows the logo for GENOZZ. The word "GENO" is in dark green, and the word "ZZ" is in light green. The font is sans-serif and bold.
Block / bright 3-Layer / bright Mono and rainbow™ Shine Material are as following;
| Device name | SUBJECT DEVICE | PREDICATED DEVICE | |
|---|---|---|---|
| rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono | rainbow™ Shine | ||
| Manufacture | Genoss Co., Ltd. | Genoss Co., Ltd. | |
| 510(K) Number | New device | K160079 | |
| Classification | Class II | Class II | |
| Product Code | EIH | EIH | |
| Clinical | Target population | Human tooth | Human tooth |
| Indication for use | rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is used in the manufacture of a dental core through milling by machine followed by sintering. | rainbow™ Shine is used in the manufacture of a dental core through milling by machine (MAD/ MAM or CAD/CAM) followed by sintering. | |
| Form | Block | Block | |
| Use | Prescription | Prescription | |
| Technical | Principle of operation | rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is a partially sintered zirconia block. To make dental prosthesis rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is processed by milling machine (CAD/CAM or MAD/ MAM) and is finally sintered | rainbow™ Shine is a partially sintered zirconia block. To make dental prosthesis, rainbow™ Shine is processed by milling machine (CAD/CAM or MAD/MAM) and is finally sintered |
| Type, Class of dental ceramic of ISO 6872 | Type II - Class 4 (ISO 6872:2015) | Type II - Class 5 (ISO 6872:2008) | |
| Flexural strength | 807.1 MPa | 865 MPa | |
| Radioactivity (Bq/g) | < 1.0 | < 1.0 | |
| Linear thermal expansion (10-6K-1) | 10.7 | 10.4±(0.5) | |
| Chemical Solubility (µg/cm²) | 28.8 | 0 | |
| Material | Zirconia Powder | Zirconia Powder | |
| Chemical Safety | Biocompatible | Biocompatible | |
| Sterilization | Non-sterile | Non-sterile | |
| Shelf-Life | None | None |
510(k) Summary
Page 3 of 5
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Image /page/7/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. The font is sans-serif and has rounded edges.
7. Performance Data
Biocompatibilitiy testing
Biocompatibility testing on the proposed rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono 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:
(P: Pass, F: Fail)
| No. | Test | Method | Acceptance criteria | P/F | Report No. |
|---|---|---|---|---|---|
| 1 | Cytotoxicity | ISO 10993-05 | None cytotoxicity | P | MGK-2019-001058 |
| 2 | Sensitization | ISO 10993-10 | None sensitization | P | MGK-2019-001060 |
| 3 | Irritation or intracutaneousreactivity | ISO 10993-10 | None irritation | P | MGK-2019-001059 |
| 4 | Systemic toxicity(acute) | ISO 10993-11 | None systemictoxicity | P | MGK-2019-001061 |
| 5 | Genotoxicity | ISO 10993-03 | No Toxicity | P | MGK-2019-001062MGK-2019-001063MGK-2019-001064 |
| 6 | Subchronic toxicity | ISO 10993-11 | No Toxicity | P | BSE-2020-06 |
| 7 | Implantation | ISO 10993-06 | No Toxicity | P | BSE-2020-06 |
| 8 | Chronic toxicity | ISO 10993-11 | No Toxicity | P | BSE-2020-06 |
| 9 | Carcinogenicity | ISO 10993-03 | No Toxicity | P | BSE-2020-06 |
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Image /page/8/Picture/0 description: The image shows the word "GENOSS" in green font. The first three letters, "GEN", are in a darker shade of green, while the last three letters, "OSS", are in a lighter shade of green. The font is bold and sans-serif, and the letters are closely spaced together.
Mechanical testing
The proposed rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono was evaluated using the following performance bench testing to confirm the performance characteristics:
| No. | Items | Properties | Method | Doc No. |
|---|---|---|---|---|
| 1 | Visual | No impurities and No specific changes | ISO 6872 | |
| 2 | Size | Standard weight <±5% | ISO 6872 | |
| 3 | Package | No damage | ISO 6872 | |
| 4 | Uniformity | Uniform after sintering | ISO 6872 | |
| 5 | Freedom fromextraneous materials | Free from extraneous materials | ISO 6872 | MT22-00554 |
| 6 | Radioactivity | 238U Less than 1.0 Bq/g | ISO 6872 | |
| 7 | Flexural strength | More than 500MPa | ISO 6872 | |
| 8 | Linear thermalexpansion | (10.7 ± 0.5) X 10-6K-1 | ISO 6872 | |
| 9 | Chemical solubility | Less than 100 µg/cm2 | ISO 6872 |
All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono met the established specifications necessary for consistent performance according to its intended use.
9. Conclusion
Based on the information provided in this premarket notification of GENOSS Co., Ltd. concluded that rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono are acceptable and safe, substantially equivalent to 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.