(191 days)
Not Found
No
The device description and performance studies focus on the material properties and physical characteristics of a dental ceramic ingot, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is a material (lithium disilicate glass-ceramic ingot) used in the manufacture of dental restorations (Inlay, Onlay, Crown), and not a device that directly provides therapy to a patient.
No
The device is a material (lithium disilicate glass-ceramic ingot) used in the manufacture of dental restorations like Inlays, Onlays, and Crowns. It is not used to diagnose a medical condition.
No
The device description clearly states it is a "lithium disilicate glass-ceramic ingot," which is a physical material, not software. The performance studies also focus on material properties like bending strength and chemical solubility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "used in the manufacture of Inlay, Onlay and Crown." This describes a material used to create dental restorations, not a test performed on a biological sample to diagnose a condition.
- Device Description: The device is described as a "lithium disilicate glass-ceramic ingot." This is a material, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis, monitoring, or screening of diseases or conditions
- Use in a laboratory or clinical setting for diagnostic purposes
The information provided clearly indicates that this device is a material used in the manufacturing process of dental prosthetics.
N/A
Intended Use / Indications for Use
rainbow™ LS Pressing is used in the manufacture of Inlay, Onlay and Crown.
Product codes
EIH
Device Description
rainbow™ LS Pressing is a lithium disilicate glass-ceramic ingot for use with the press technique with similar strength and esthetics to natural 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
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
- Glass transition temperature
Technical characteristics of both devices satisfy the criteria for Type II - Class 2 or 3' dental ceramic 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
Bending Strength: 569 MPa (subject device), 400 Mpa (predicate device). Requirement by ISO 6872:2008 for Class 3 dental ceramics (> 300 Mpa).
Linear thermal expansion coefficient: (10.3±0.5) x 10-6K-1 (subject device), 10.5 x 10-6K-1 (predicate device).
Chemical Solubility: 35.75 µg/cm² (subject device), 40 µg/cm² (predicate device). Requirement by ISO 6872:2008 for Class 2 or 3 dental ceramics (
§ 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular pattern.
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: K151846
Trade/Device Name: rainbow™ LS Pressing Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: December 4, 2015 Received: December 8, 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 "GENOSYS" in a stylized font. The letters are composed of small, repeating patterns, giving them a textured appearance. The overall design is simple and clean, with a focus on the typography.
Indication for use
510(k) Number: K151846
rainbow™ LS Pressing Device Name:
Indication for use:
rainbow™ LS Pressing is used in the manufacture of Inlay, Onlay and Crown.
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
Page 1 of 1
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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 logo is simple and modern.
510(k) Summary
01/05/2016
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 | 01/05/2016 |
2. Device Name
| Proprietary name | : rainbow™ LS Pressing |
|---|---|
| Regulation number | : 21 CFR 872.6660 |
| Classification name | : Porcelain powder for clinical use |
| Product code | : EIH |
| Device class | : Class II |
3. Predicate Device
K120134 IPS e.max Press and IPS e.max Press Multi
4. Description
rainbow™ LS Pressing is a lithium disilicate glass-ceramic ingot for use with the press technique with similar strength and esthetics to natural tooth.
5. Indication for use
rainbow™ LS Pressing is used in the manufacture of Inlays, Onlays and Crowns.
4
Image /page/4/Picture/0 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. The letters are connected to each other.
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™ LS Pressing and the predicate.
| Device name | rainbowTM LS Pressing | IPS e.max Press
and IPS e.max Press Multi | Comparison |
|--------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Genoss Co., Ltd. | Ivoclar Vivadent,
Incorporated | N/A |
| 510(k) Number | New Device | K120134 | N/A |
| Materials | SiO2, Li2CO3, Ca3(PO4)2,
P2O5, ZnO, Al2O3, La2O3,
K2CO3. etc. | SiO2, Li2O, K2O, MgO,
ZnO, Al2O3, P2O5 etc. | 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%.
The difference of
composition is Ca3(PO4)2.
Ca3(PO4)2 is decomposed
into 3CaO and P2O5.
The CaO acts as stabilizer. |
| Form | Pre-formed Ingot | Pre-formed Ingot | Same |
| Type, class of
dental ceramic | Type II - Class 2 | Type II - Class 3 | Similar
Although the subject
device refers to Type II-
Class 2 dental ceramic, the
bending strength satisfies
requirement by
ISO 6872:2008 for
Class 3 dental ceramics
(> 300 MPa). |
| Sterilization | Non-sterile | Non-sterile | Same |
| | | | |
| Indication for use | rainbow™ LS Pressing is
used in the manufacture of
Inlays, Onlays and
Crowns. | IPS e.max Press and IPS
emax Press Multi is an all-
ceramic system for the
creation of Occlusal
veneers, Thin Veneers,
Veneers, Inlays, Onlays,
Crowns in the anterior and
posterior region, 3-unit
bridges in the anterior
region, 3-unit bridges in
the premolar region up to
the second premolar as the
terminal abutment, Crown,
splinted crown or 3 unit
bridge up to the second
premolar placed on top of
an implant abutment. | Similar
The subject and predicate
devices can be used to
make Inlays, Onlays and
Crowns, because the
bending strength and
chemical solubility of
devices satisfy
requirement by
ISO 6872:2008 for
Class 4 dental ceramics.
(> 300 Mpa, 300 Mpa ) |
| Linear thermal
expansion
coefficient | $(10.3±0.5) x 10-6K-1$ | $10.5 x 10-6K-1$ | Same |
| Chemical Solubility
(µg/cm²) | 35.75 | 40 | Chemical solubility
satisfies requirement by
ISO 6872:2008 for
Class 2 or 3 dental
ceramics.
( 300 MPa), the subject and predicate devices can be used to make Inlays, Onlays and Crowns.
-
- The subject and predicate device have slight difference in materials. But they both are lithium disilicate dental ceramic which have SiO2 and Li2O as the major materials. The each composition of other materials is less than 5%. The difference of chemical composition is Cas(PO4)2, which is decomposed into 3CaO and P2O5. The CaO acts as stabilizer. It enhances the structure of Li2O-SiO2 system(the basic lithium disilicate system) and increases the viscosity of glass. This difference has no effect on the device. The non-clinical test and biocompatibility test) demonstrate the Technical characteristics.
-
- The differences of technological characteristics(Bending strength, chemical solubility) are within what is expected of this type of device. The performance test results satisfy the requirement for Type II - Class 2 or 3 dental ceramic by ISO 6872:2008.
7. Summary of non-clinical testing
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
-
Glass transition temperature
-
510(k) Summary
7
GENOSS
Technical characteristics of both devices satisfy the criteria for Type II - Class 2 or 3' dental ceramic by ISO 6872:2008. Slight differences between the proposed and predicate devices do not raise any new issues of safety and effectiveness.
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.
8. Conclusion
Based on the information provided in this premarket notification of GENOSS Co., Ltd. concludes that rainbow™ LS Pressing is substantially equivalent to predicate device.