(182 days)
Not Found
No
The description focuses on the material composition and manufacturing process of a dental ceramic block, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is a dental ceramic block used to manufacture crowns, veneers, inlays, and onlays, which are prosthetic replacements for teeth, not therapeutic treatments. The performance studies focus on material characteristics and biocompatibility, not therapeutic efficacy.
No
The device is a dental ceramic used for manufacturing dental prosthetics like crowns and veneers, not for diagnosing medical conditions.
No
The device description clearly states it is a dental ceramic block made of Lithium disilicate, which is a physical material, not software. The performance studies also focus on the physical and biological properties of this material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for manufacturing dental restorations (Crown, Veneer, Inlay, Onlay). This is a structural and restorative application within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a dental ceramic material used to create physical dental prosthetics. It is not designed to analyze biological samples or provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
The device is clearly a dental material used in the creation of medical devices (dental prosthetics). The performance studies focus on the material's physical properties and biocompatibility for its intended use in the mouth.
N/A
Intended Use / Indications for Use
rainbow™ LS Block can be used for manufacturing Crown, Veneer, Inlay and Onlay.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
rainbow™ LS Block is a dental ceramic made out of Lithium disilicate. rainbow™ LS Block is milled into cores of teeth and then is fired in a furnace to harden the Li2Si2O3. 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)
The proposed rainbow™ LS Block was evaluated using performance bench testing to confirm the performance characteristics regarding:
- Visual characteristics: No impurities and No specific changes (Result: 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 features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, conveying the department's authority and purpose.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 21, 2016
GENOSS Co., Ltd. % Kim Byungsun Assistant Manager ICT America, Inc. 180 Sylvan Avenue, 2nd Floor Englewood Cliffs. New Jersey 07632
Re: K160144
Trade/Device Name: rainbow™ LS Block Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: June 13, 2016 Received: June 15, 2016
Dear Kim Byungsun:
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,
Michael J. Ryan -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 "GENO" are in a dark green color, while the letters "SS" are in a lighter green color. The font is bold and sans-serif.
Indication for use
510(k) Number:
Device Name: rainbow™ LS Block
Indication for use:
rainbow™ LS Block can be used for manufacturing Crown, Veneer, Inlay and Onlay.
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 contains 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 "OSS" are connected by a green line that runs underneath them.
510(k) Summary
03/28/2016
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/ +82-31-888-5595 |
Contact person | Han Yein / RA |
yihan@genoss.com | |
Summary Date | 03/28/2016 |
2. Device Name
Proprietary name | : rainbow TM LS Block |
---|---|
Regulation number | : 21 CFR 872.6660 |
Classification name | : Porcelain powder for clinical use |
Product code | : EIH |
Device class | : Class II |
3. Predicated Device
K051705 IPS e.max CAD
4. Description
rainbow™ LS Block is a dental ceramic made out of Lithium disilicate. rainbow™ LS Block is milled into cores of teeth and then is fired in a furnace to harden the Li2Si2O3. Then, the core is layered with porcelain to make a finished tooth.
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Image /page/4/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 slightly rounded, giving the word a modern and professional look.
5. Indication for use
rainbow™ LS Block can be used for manufacturing Crown, Veneer, Inlay and Onlay.
6. Technological Characteristics
rainbow™ LS Block has the similar technological characteristics as the predicate device; main material, indication for use and design. Technological characteristics of rainbow™ LS Block, IPS e.max CAD is as following
Device name | rainbow™ LS Block | IPS e.max CAD | Comparison | |
---|---|---|---|---|
Manufacturer | Genoss Co., Ltd. | ivoclar vivadent | N/A | |
510(k) Number | New Device | K051705 | N/A | |
Materials | SiO2, Li2CO3, Ca3(PO4)2, | |||
P2O5, ZnO, Al2O3, La2O3, | ||||
K2CO3, ZrO2 | SiO2, Li2O, K2O, MgO, | |||
ZnO, Al2O3, P2O5, ZrO2 | Similar | |||
The major materials of | ||||
lithium disilicate dental | ||||
ceramic(subject and | ||||
predicate device) are SiO2 | ||||
and Li2O. | ||||
The each composition | ||||
of other materials is | ||||
less than 5%. | ||||
Form | Preformed block | Preformed block | Same | |
Type, class of | ||||
dental ceramic | Type II - Class 2 | Type II - Class 2 | Same | |
Sterilization | Non-sterile | Non-sterile | Same | |
Indication for use | rainbow™ LS Block can | |||
be used for manufacturing | ||||
Crown, Veneer, Inlay and | ||||
Onlay. | IPS e.max CAD is a | |||
CAD/CAM machinable | ||||
glass ceramic based on | ||||
lithium disilicate for the | ||||
preparation of full ceramic | ||||
crowns, inlays, onlays, and | ||||
full ceramic 3-unit anterior | ||||
bridges. | Similar | |||
The subject has more | ||||
strong bending strength | ||||
than the predicate devices. | ||||
Subject not intended for | ||||
anterior bridges. | ||||
Use | Prescription | Prescription | Same | |
Technical characteristics | ||||
Bending Strength | ||||
(Flexural strength) | 370MPa | 360MPa | Similar | |
Bending strength is | ||||
little higher than predicate | ||||
device but there is no | ||||
difference in performance | ||||
and safety. | ||||
Linear Thermal | ||||
expansion | ||||
( $10^{-6}K^{-1}$ ) | 10.3±0.5 | 10.45 | Same | |
Radioactivity | ||||
(Bq/g) | 0.00628 |