(294 days)
No
The device description and performance studies focus on the material properties and physical characteristics of a dental veneering paste, with no mention of AI or ML.
No.
The device is a dental veneering material for fixed prostheses in crowns and bridges, which serves a restorative and aesthetic purpose, not a therapeutic one.
No
The device is described as a dental veneering material used for color staining and glazing of dental restorations, not for diagnosing conditions.
No
The device description clearly states it is a dental veneering material in paste form, composed of paste and liquid, which are physical substances, 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 "as a veneering material for fixed prosthesis in crowns and bridges." This describes a material used in the mouth for restorative purposes, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a dental veneering material in paste form used for color staining and glazing of dental restorations. This is a physical material applied to a dental device.
- Lack of Diagnostic Purpose: There is no mention of this device being used to detect, measure, or analyze any substance or characteristic from a human body sample (like blood, urine, tissue, etc.) for the purpose of diagnosis, monitoring, or screening.
- Anatomical Site: The anatomical site is "fixed prosthesis in crowns and bridges," which are dental devices placed in the mouth.
- Performance Studies: The performance studies focus on material properties like bending strength, chemical solubility, thermal expansion, and biocompatibility, which are relevant to the physical and biological compatibility of a dental material, not the accuracy of a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. This device is a dental material used for restoring and enhancing the appearance of dental prosthetics.
N/A
Intended Use / Indications for Use
rainbow Paste Stain is indicated for use as a veneering material for fixed prosthesis in crowns and bridges. This device is used in prosthetic dentistry by forming a porcelain veneer on to a ceramic substructure.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
rainbow™ Paste Stain is a dental veneering material in paste form used for color staining and glazing of the surfaces of restorations such as porcelain-fused zirconia, full-contoured zirconia, or lithium disilicate.
The intended use of general porcelain is to make the artificial teeth (dental prosthesis) more similar with natural teeth. The subject device is pre-mixed paste form, which can help dental technicians exclude mixing process of porcelain powder and liquid.
The subject device is composed of 16 shade paste and thinner (Paste Stain Liquid), does not include powder only. The thinner is used to control viscosity of paste.
Each paste has 3 volumes of 3g, 5g and 7g. The kit package is composed of various pastes and a liquid.
The subject device is not intended to be marketed with multiple components or accessories. It is only composed with the products in this submission which are powder and liquid.
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
- Glass transition temperature
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): 79 MPa (subject device), approx. 100 MPa (predicate device).
Chemical Solubility (µg/cm2): 24 (subject device), approx. 10 (predicate device).
Linear thermal expansion coefficient: (9.5±0.5) x 10^-6 K^-1 (subject device), (9.0 ~ 9.2) x 10^-6 K^-1 (predicate device).
Glass transition temperature: 476 °C (subject device), approx. 600 °C (predicate device).
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.
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).
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.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 15. 2016
GENOSS Co. Ltd. Mr. Byungsun Kim Regulatory Affairs Assistant 105 Gwanggyo-ro Suwon-si Yeongtong-gu Gyeonggi-do 443-270 KOREA
Re: K151731
Trade/Device Name: rainbow™ Paste Stain Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: March 14, 2016 Received: March 15, 2016
Dear Mr. 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
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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,
Erin I. Keith -S
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 logo for GENOSS. 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 the letters are bolded.
Indication for use
510(k) Number: K151731
Device Name: rainbow™ Paste Stain
Indication for use:
rainbow™ Paste Stain is indicated for use as a veneering material for fixed prosthesis in crowns and bridges. This device is used in prosthetic dentistry by forming a porcelain veneer on to a ceramic substructure.
Prescription Use (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
04/11/2016
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 | 04/11/2016 |
2. Device Name
| Proprietary name | : rainbow TM Paste Stain |
|---|---|
| Regulation number | : 21 CFR 872.6660 |
| Classification name | : Porcelain powder for clinical use |
| Product code | : EIH |
| Device class | : Class II |
3. Predicate Device
| K060441 | Primary predicate |
|---|---|
| K052710 | Reference predicate |
4. Description
rainbow™ Paste Stain is a dental veneering material in paste form used for color staining and glazing of the surfaces of restorations such as porcelain-fused zirconia, full-contoured zirconia, or lithium disilicate.
The intended use of general porcelain is to make the artificial teeth (dental prosthesis) more similar
510(k) Summary
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Image /page/4/Picture/1 description: The image shows the word "GENOSS" in a stylized font. The first three letters, "GEN", are in a dark green color. The last three letters, "OSS", are in a lighter green color.
with natural teeth. The subject device is pre-mixed paste form, which can help dental technicians exclude mixing process of porcelain powder and liquid.
The subject device is composed of 16 shade paste and thinner (Paste Stain Liquid), does not include powder only. The thinner is used to control viscosity of paste.
Each paste has 3 volumes of 3g, 5g and 7g. The kit package is composed of various pastes and a liquid.
The subject device is not intended to be marketed with multiple components or accessories. It is only composed with the products in this submission which are powder and liquid.
5. Indication for use
rainbow™ Paste Stain is indicated for use as a veneering material for fixed prosthesis in crowns and bridges. This device is used in prosthetic dentistry by forming a porcelain veneer on to a ceramic substructure.
6. Technological Characteristics
rainbow™ Paste Stain has the similar technological characteristics as the predicate device; main material, indication for use and design. Technological characteristics of rainbow™ Paste stain and Vita VM®(K060441, K052710) are as following
| Device name | rainbow™ Paste Stain | Vita VM®
(VITA VM9) | Comparison |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Genoss Co., Ltd. | Vident | N/A |
| 510(k) Number | New Device | K06044, K052710 | N/A |
| Materials | Feldspar, SiO2, Na2CO3
K2CO3, Li2CO3, CaCO3
ZnO, etc. | Feldspar, Na2CO3, Al2O3,
CaCO3, K2CO3, BaCO3,
etc. | Similar
The subject and predicate
device both have feldspar and
several oxides as the major
component. |
| Form | Paste | Powder + Liquid | Similar
The subject device is
pre-mixture of powder and
liquid for ease of use |
| Type, class of
dental ceramic | Type I - Class I | Type I - Class I | Same |
| Sterilization | Non-sterile | Non-sterile | Similar |
| Indication for use | rainbowTM Paste Stain is
indicated for use as a
veneering material for
fixed prosthesis in crowns
and bridges. This device is
used in prosthetic
dentistry by forming a
porcelain veneer on to a
ceramic substructure. | Vita VM® porcelains are
indicated for use as a
veneering material for
fixed prosthesis in crowns,
bridges, and dental
implant abutments. These
devices are used in
prosthetic dentistry by
forming a porcelain
veneer on to a ceramic or
metal substructure into the
shape of a dental crown. | The predicate device has
several proprietary names
(VM7, VM9, VM11, VM13)
The subject device and Vita
VM9 are used to veneer over
the ceramic substructure
(denatl core)
*Vita VM7 is applicable to
alumina substructures.
*Vita VM9 is applicable to
zirconia substructures.
*Vita VM11 is applicable to
lithium silicate substructures.
*Vita VM13 is applicable to
gold or metal substructures. |
| Use | Prescription | Prescription | Same |
| Technical characteristics | | | |
| Bending Strength
(Flexural strength) | 79 MPa | approx. 100 MPa | Flexural strength is
lower, but higher
than required by
ISO 6872:2008 for
Class I dental ceramics
(> 50 MPa). |
| Chemical Solubility
(µg/cm2) | 24 | approx. 10 | Chemical solubility
satisfies requirement by
ISO 6872:2008 for
Class I dental ceramics
(