(217 days)
Not Found
No
The device description focuses on the material composition and manufacturing process of a dental ceramic block used in CAD/CAM or MAD/MAM milling, with no mention of AI or ML for analysis, design, or processing.
No.
The device is a raw material (partially sintered dental ceramic) used to manufacture dental cores, crowns, and bridges, which are restorative devices, not therapeutic devices.
No
This device is a partially sintered dental ceramic block used to manufacture dental cores (substructures for artificial teeth) through milling and sintering. It is a material used in the fabrication of dental restorations, not a device that diagnoses a condition or disease.
No
The device is a physical dental ceramic block used in the manufacturing process of dental restorations. It is a material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "manufacture of a dental core through milling by machine followed by sintering." This describes a process for creating a physical dental restoration.
- Device Description: The device is a "partially sintered dental ceramic made out of colored ZrO2(Y-TZP)" that is "milled into core (zirconia substructure) of artificial teeth and then is finally sintered in a furnace to harden the ZrO2." This is a material used in a manufacturing process.
- Function: The device is a material that is shaped and processed to become part of a dental restoration (crowns and bridges). It does not perform any diagnostic function.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not interact with bodily samples for diagnostic purposes.
The device is a material used in the fabrication of a medical device (dental restoration), but it is not a diagnostic device itself.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human tooth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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: Cytotoxicity, Sensitization, Irritation or intracutaneous reactivity, Systemic toxicity(acute), Genotoxicity, Subchronic toxicity, Implantation, Chronic toxicity, Carcinogenicity. All tests passed.
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: Visual, Size, Package, Uniformity, Freedom from extraneous materials, Radioactivity, Flexural strength, Linear thermal expansion, Chemical solubility. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural strength: 807.1 MPa
Radioactivity (Bq/g):
§ 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.
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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
3
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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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 Korea | |
| Manufacturing 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 / RA |
| hysung@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) |