(191 days)
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No
The summary describes a material (partially sintered dental ceramic) used in the manufacturing process of dental cores. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI/ML. The performance studies focus on material properties and biocompatibility.
No
The device is a partially sintered dental ceramic used in the manufacturing process of dental cores, which are then layered with porcelain to make finished artificial teeth. It is a material used as a component of a medical device, not a therapeutic device itself.
No
The device is a material used in the manufacturing process of dental cores/artificial teeth; it does not diagnose any condition.
No
The device description clearly states it is a "partially sintered dental ceramic made out of colored ZrO2(Y-TZP)" and describes its physical properties and manufacturing process, indicating it is a physical material, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
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 material used in a manufacturing process for a dental prosthesis.
- Device Description: The description details a "partially sintered dental ceramic" that is milled and then sintered to create a dental core. This is a material used to build a physical structure.
- Lack of IVD Characteristics: IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with human specimens in this way. It is a material used to create a medical device (a dental prosthesis).
Therefore, rainbow™ Shine is a material used in the manufacturing of a dental device, not an IVD.
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). 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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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. 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.
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.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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 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
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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
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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, 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 | 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.
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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 of | |||
| dental ceramic | Type II - Class 5 | Type II - Class 6 | The subject and predicate |
| devices satisfy dental | |||
| ceramic classification | |||
| requirement by | |||
| ISO 6872:2008 | |||
| Sterilization | Non-sterile | Non-sterile | Same |
| Indication for | |||
| use | rainbowTM Shine is used in | ||
| the manufacture of a dental | |||
| core through milling by | |||
| machine (MAD/ MAM or | |||
| CAD/CAM) followed by | |||
| sintering. | Rainbow Block is used in | ||
| the manufacture of a dental | |||
| core through milling by | |||
| machine (MAD/MAM or | |||
| CAD/CAM) followed by | |||
| sintering. | Same | ||
| Use | Prescription | Prescription | Same |
| Technical characteristics | |||
| Bending | |||
| Strength | |||
| (Flexural | |||
| strength) | 706MPa | 1144MPa | Bending strength is |
| higher than required by | |||
| ISO 6872:2008 for | |||
| Class 5 dental ceramics. | |||
| ( > 500 Mpa ) | |||
| Sintering Density | |||
| (g/cm3) | 6 | 6.00~6.04 | Same |
| Radioactivity | |||
| (Bq/g) |