(101 days)
Not Found
No
The summary describes a dental ceramic material and its physical properties and testing, with no mention of AI or ML.
No
The device is a pre-sintered zirconia block used to fabricate dental restorations (single-tooth and bridgework), not a device that directly provides therapy. It is a material used in the creation of a prosthetic device.
No
This device is a pre-sintered zirconia block used for the fabrication of dental restorations (single-tooth and bridgework), not for diagnosing conditions. Its purpose is to be milled into cores of teeth and then hardened and layered with porcelain to create a finished tooth, which is a therapeutic rather than a diagnostic function.
No
The device is a physical dental ceramic block (pre-sintered zirconia) used for fabricating dental restorations, not a software application.
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 fabrication of dental restorations (single-tooth and bridgework). This is a structural and restorative purpose, not for diagnosing a condition or disease.
- Device Description: The device is a material (zirconia block) used to create dental prosthetics. It's a component in a manufacturing process for a medical device (the dental restoration).
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device is a material used in the creation of a dental prosthetic.
N/A
Intended Use / Indications for Use
rainbow™ Shade is a pre-sintered zirconia(Y-TZP) block for fabrication of single-tooth and bridgework restoration.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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™ 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: Cytotoxicity, Sensitization (Local Lymph Node Assay), Oral mucosa irritation, Acute systemic toxicity, Genotoxicity.
The proposed rainbow™ Shade was evaluated using the following performance bench testing to confirm the performance characteristics: Visual (No impurities and No specific changes), Size (Size error of; Standard Size
§ 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/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, 105 |
| Gwanggyo-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea | |
| Phone/Fax | +82-31-888-5100/ +82-31-888-5105 |
| Contact person | Byungsun Kim / RA |
| bskim@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-sintered | |
| zirconia(Y-TZP) block for | ||
| fabrication of single-tooth and | ||
| bridgework restoration. | Rainbow Block is used in the | |
| manufacture of a dental core through | ||
| milling by machine (MAD/MAM or | ||
| CAD/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 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 |
| 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 impurities | ||
| and No specific changes | No impurities | |||
| and No specific changes | ISO 6872 | |||
| 2 | Size | Size error of; | ||
| Standard Size |