rainbow™ LS Pressing is a lithium disilicate glass-ceramic ingot for use with the press technique with similar strength and esthetics to natural tooth.

AI/ML Overview

The provided document is a 510(k) Summary for a dental ceramic device, "rainbow™ LS Pressing." It outlines the device's characteristics and its substantial equivalence to a predicate device, IPS e.max Press and IPS e.max Press Multi. The document describes several non-clinical tests conducted to confirm the device's performance against established standards.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Standard)	Predicate Device Performance (IPS e.max Press and IPS e.max Press Multi)	Subject Device Performance (rainbow™ LS Pressing)	Comparison/Conclusion
Bending Strength (ISO 6872:2008 for Class 3 dental ceramics: > 300 MPa)	400 Mpa	569 MPa	Subject device is higher than both predicate and required standard.
Chemical Solubility (ISO 6872:2008 for Class 2 or 3 dental ceramics: < 100 µg/cm²)	40 µg/cm²	35.75 µg/cm²	Both devices satisfy the requirement.
Linear thermal expansion coefficient	10.5 x 10⁻⁶ K⁻¹	(10.3 ± 0.5) x 10⁻⁶ K⁻¹	Similar.
Glass transition temperature	approx. 549 ℃	(550 ± 20) ℃	Similar.
Biocompatibility (ISO 10993-1)	Biocompatible	Biocompatible	Both are biocompatible.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for the non-clinical tests (bending strength, chemical solubility, linear thermal expansion coefficient, glass transition temperature, or biocompatibility tests).
The country of origin for the submitter, GENOSS Co., Ltd., is Korea. The document does not explicitly state the provenance of the test data (e.g., where the testing was physically conducted). The study appears to be an internal bench testing conducted by the manufacturer, which is typically considered prospective for the purposes of device validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the document describes non-clinical bench testing for material properties and biocompatibility, not studies involving expert adjudication of medical images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable. As mentioned above, the study focuses on laboratory testing of material properties, not diagnostic performance requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. The device is a dental ceramic material, not an AI-powered diagnostic tool, therefore MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This section is not applicable. The device is a material, not an algorithm. The non-clinical tests can be considered "standalone" in the sense that they evaluate the material properties directly.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" is established by adherence to recognized international standards:

ISO 6872:2008 for dental ceramic materials (specifically for bending strength and chemical solubility).
ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-03 for biocompatibility testing.

These standards define the methodologies and acceptable limits for the measured physical and biological properties.

8. The sample size for the training set

This section is not applicable. The context is the evaluation of a dental material, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

This section is not applicable for the same reason as point 8.

Summary

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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.

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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, 105Gwanggyo-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea
Phone/Fax	+82-31-888-5100/ +82-31-888-5105
Contact person	Byungsun Kim / RAbskim@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.

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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 Pressand 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.	SimilarThe major materials oflithium disilicate dentalceramic(subject andpredicate device) are SiO2and Li2O.The each compositionof other materials isless than 5%.The difference ofcomposition is Ca3(PO4)2.Ca3(PO4)2 is decomposedinto 3CaO and P2O5.The CaO acts as stabilizer.
Form	Pre-formed Ingot	Pre-formed Ingot	Same
Type, class ofdental ceramic	Type II - Class 2	Type II - Class 3	SimilarAlthough the subjectdevice refers to Type II-Class 2 dental ceramic, thebending strength satisfiesrequirement byISO 6872:2008 forClass 3 dental ceramics(> 300 MPa).
Sterilization	Non-sterile	Non-sterile	Same

Indication for use	rainbow™ LS Pressing isused in the manufacture ofInlays, Onlays andCrowns.	IPS e.max Press and IPSemax Press Multi is an all-ceramic system for thecreation of Occlusalveneers, Thin Veneers,Veneers, Inlays, Onlays,Crowns in the anterior andposterior region, 3-unitbridges in the anteriorregion, 3-unit bridges inthe premolar region up tothe second premolar as theterminal abutment, Crown,splinted crown or 3 unitbridge up to the secondpremolar placed on top ofan implant abutment.	SimilarThe subject and predicatedevices can be used tomake Inlays, Onlays andCrowns, because thebending strength andchemical solubility ofdevices satisfyrequirement byISO 6872:2008 forClass 4 dental ceramics.(> 300 Mpa, < 2000µg/cm²)
Use	Prescription	Prescription	Same
Technical characteristics
Bending Strength(Flexural strength)	569 MPa	400 Mpa	Bending strength ishigher than required byISO 6872:2008 forClass 3 dental ceramics.( > 300 Mpa )
Linear thermalexpansioncoefficient	$(10.3±0.5) x 10-6K-1$	$10.5 x 10-6K-1$	Same
Chemical Solubility(µg/cm²)	35.75	40	Chemical solubilitysatisfies requirement byISO 6872:2008 forClass 2 or 3 dentalceramics.(< 100µg/cm²)
Glass transitiontemperature	(550±20) ℃	approx. 549 ℃	Same
Biocompatibility	Biocompatible	Biocompatible	The Products arebiocaompatible accordingto ISO 10993-1'Biological evaluation ofmedical devices –Part 1: Evaluation andtesting within a riskmanagement process.

Comparison of Characteristics

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Image /page/5/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 font is sans-serif and has a modern look.

510(K) Number: K151846

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510(K) Number: K151846

Image /page/6/Picture/1 description: The image shows the logo for GENOSS. The logo is in green and consists of the word "GENOSS" in a sans-serif font. The first three letters, "GEN", are in a darker green, while the last three letters, "OSS", are in a lighter green. The logo is simple and modern.

Image /page/6/Figure/2 description: The image shows a comparison of shapes and sizes of what appears to be dental materials. On the left, there is a cylinder with a diameter of 12.5mm and a height of 10mm. In the middle, there are multiple cylinders with a diameter of 12.5mm and heights of 10mm and 20mm. The right side of the image is labeled 'Similar'.

There are three minor differences that are worth discussing:

1. The difference of 'Indication for use' is not critical to the intended use.
  Considering the bending strength of devices satisfies requirement by ISO 6872:2008 for Class 4 dental ceramics(> 300 MPa), the subject and predicate devices can be used to make Inlays, Onlays and Crowns.
1. 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.
1. 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

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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.

Regulation Number and Section

§ 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.