(301 days)
K151842 rainbow™ High Shine
Not Found
No
The description focuses on the material properties and manufacturing process of a dental ceramic blank, with no mention of AI or ML in the device itself or its intended use.
No.
The device is a partially sintered material used in the manufacture of dental core for crowns and bridges, not a therapeutic device delivered to a patient to treat or cure a disease.
No
This device is a partially sintered dental ceramic used in the manufacturing process of dental cores for crowns and bridges, not for diagnosing medical conditions. It is a material for fabrication, not a diagnostic tool.
No
The device description clearly states that rainbow™ Shine is a "partially sintered dental ceramic made out of colored ZrO2(Y-TZP)" and is a physical blank used in the manufacturing process of dental cores. This indicates it is a physical 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 and sintering to create dental restorations (crowns and bridges). This is a manufacturing process for a medical device that will be implanted or used in the body.
- Device Description: The device is a partially sintered ceramic blank used to fabricate dental restorations. It is a material used in the creation of a medical device.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device intended to be used in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
This device does not examine specimens from the human body and is not used to provide diagnostic information. It is a material used in the fabrication of a dental prosthesis, which is a medical device.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device 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.
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.
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)
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
- Chemical Solubility
- Linear thermal expansion coefficient
- 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.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bending Strength (Flexural strength): 865MPa
Sintering Density: 6 g/cm³
Radioactivity:
§ 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.
0
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
1
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, 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 | 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 of | |||
| dental ceramic | Type II - Class 5 | Type II - Class 5 | Same |
| Sterilization | Non-sterile | Non-sterile | Same |
| 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. | rainbow™ High Shine is | ||
| used in the manufacture of a | |||
| dental core through milling | |||
| by machine (MAD/ MAM | |||
| or CAD/CAM) followed by | |||
| sintering. | Same | ||
| Principle of | |||
| operations | 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. | rainbow™ High Shine is a | ||
| partially sintered zirconia | |||
| block. To make dental | |||
| prosthesis, rainbow™ High | |||
| Shine is processed by | |||
| milling | |||
| machine(CAD/CAM or | |||
| MAD/ MAM) and is finally | |||
| sintered. | Same | ||
| Use | Prescription | Prescription | Same |
| Technical characteristics | |||
| Bending | |||
| Strength | |||
| (Flexural | |||
| strength) | 865MPa | 706MPa | Bending strength is |
| higher than required by | |||
| ISO 6872:2008 for | |||
| Class 5 dental ceramics. | |||
| ( > 500 Mpa ) | |||
| Sintering Density | |||
| (g/cm³) | 6 | 6 | Same |
| Radioactivity | |||
| (Bq/g) |