(53 days)
Not Found
No
The summary describes a dental ceramic block used for milling, with no mention of AI or ML in its function or processing.
No
The device is a dental ceramic block used to manufacture dental cores, which are then layered with porcelain to make a finished tooth. It is a material used in the creation of a prosthetic device, not a therapeutic device itself.
No
Explanation: The device is described as a dental ceramic used in the manufacture of dental cores, not for diagnosing any medical condition.
No
The device description clearly states that Rainbow Block is a dental ceramic made out of zirconia, which 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. This is a manufacturing process for a dental prosthetic component.
- Device Description: The device is a dental ceramic material (zirconia) used to create a core for a tooth.
- Lack of Diagnostic Purpose: There is no mention of this device being used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. IVDs are typically used in laboratory settings or point-of-care testing to analyze biological samples.
This device falls under the category of a dental material used in the creation of a dental prosthetic.
N/A
Intended Use / Indications for Use
Rainbow Block is used in the manufacture of a dental core through milling by machine (MAD/MAM or CAD/CAM) followed by sintering.
Product codes
EIH
Device Description
Rainbow Block is a dental ceramic made out of zirconia. Rainbow Block is milled into cores for teeth and then is fired in the furnace to harden of 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)
Rainbow Block has been subjected to extensive safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
K0925/3
GENOSS
OCT - 9 2009
510(k) Summary
30th June, 2009
1. Company
ﺎ ﺗ
it
| Submitter | |
|---|---|
| Name | Genoss Co., Ltd. |
| Address | Gyeonggi R&DB Center 1F, 906-5 lui-dong, Suwon-si Yeongtong-gu, |
| Gyeonggi-do, 443-766, Korea | |
| Phone / Fax | +82 31 888 5100 / +82 31 888 5105 |
| Contact person | Kim, Yookang / QA |
| ykkim@implantium.com |
2. Device Name
Proprietary name: Rainbow Block Dental frame material for Dental prosthesis Common name: Porcelain, powder for clinical use Classification name:
3. Predicated Device
| K061851 | Zirkonzahn Ice |
|---|---|
| K063511 | Ceramill Zi Blank |
4. Description
Rainbow Block is a dental ceramic made out of zirconia. Rainbow Block is milled into cores for teeth and then is fired in the furnace to harden of ZrO2. Then the core is layered with porcelain to make a finished tooth.
.
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1
5. Indication for Use
Rainbow Block is used in the manufacture of a dental core through milling by machine (MAD/MAM or CAD/CAM) followed by sintering.
6. Review
Rainbow Block has the similar technological characteristics as the predicate devices; Main material, Indication for use and design.
Rainbow Block has been subjected to extensive safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.
7. Conclusions
Based on the information provided in this premarket notification of Genoss Co., Ltd. concludes that Rainbow Block is safe and effective and substantially equivalent to predicate devices as described herein.
2
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Genoss Company, Limited C/O Dr. Eunkyung Son Dentium USA 11075 Knott Avenue, Suite A Cypress, California 90630
OCT - 9 2009
Re: K092513
Trade/Device Name: Rainbow Block Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: August 5, 2009 Received: August 17, 2009
Dear Dr. Son:
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.
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.
3
Page 2 - Dr. Sun
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
ph for
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the word "GENOSS" in a bold, sans-serif font. The letters are all capitalized and appear to be slightly slanted to the right. The word is likely a brand name or a title.
Indications for Use
K692513 510(k) Number:
Device Name: Rainbow Block
Indications for Use:
Rainbow Block is used in the manufacture of a dental core through milling by machine (MAD/MAM or CAD/CAM) followed by sintering.
Prescription Use 2 (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)
Reen: Mrelof for MSR
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:10(k) Number: K092513