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.

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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the rainbow™ Paste Stain, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against the requirements for Type I - Class I dental ceramics as outlined in ISO 6872:2008.

Performance Metric	Acceptance Criteria (ISO 6872:2008 for Class I)	Reported Device Performance (rainbow™ Paste Stain)	Predicate Device Performance (Vita VM®)	Comparison and Compliance
Bending Strength (Flexural Strength)	> 50 MPa	79 MPa	approx. 100 MPa	Satisfied: Although lower than the predicate, it is significantly higher than the minimum requirement.
Chemical Solubility (µg/cm²)	< 100 µg/cm²	24 µg/cm²	approx. 10 µg/cm²	Satisfied: Meets the requirement, though higher than the predicate.
Linear Thermal Expansion Coefficient	Not explicitly stated as a hard limit in the document, but assessed for similarity/compatibility with firing schedules.	(9.5 ± 0.5) x 10⁻⁶ K⁻¹	(9.0 ~ 9.2) x 10⁻⁶ K⁻¹	Similar: Within a comparable range, and considered in conjunction with the firing schedule.
Glass Transition Temperature	Not explicitly stated as a hard limit in the document, but assessed for similarity/compatibility with firing schedules.	476 °C	approx. 600 °C	Differences noted: However, "the subject and predicate device have each firing schedule reflecting these two technological characteristics." This implies the device is used with appropriate firing parameters.
Biocompatibility	Biocompatible (based on ISO 10993 series)	Biocompatible	Biocompatible	Satisfied: Tested and deemed biocompatible.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific bench test (bending strength, chemical solubility, etc.) for the subject device or the predicate device. It also does not provide details on the data provenance in terms of country of origin or whether the data was retrospective or prospective. The testing was described as "non-clinical device testing" for performance comparison.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. The device is a dental material, and its performance is evaluated through bench testing against established international standards (ISO 6872:2008), not through human expert assessment of a test set where a "ground truth" would be established by experts.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation is based on objective measurements from bench tests against a standard, not on expert opinion requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret results, and the document describes a dental material evaluated through bench testing.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study in the context of an algorithm or AI is not applicable. This device is a physical dental material, not a software algorithm. The "standalone" performance here refers to the device's intrinsic material properties as measured by bench tests.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of rainbow™ Paste Stain is the ISO 6872:2008 international standard for dentistry - ceramic materials. The device's performance metrics were measured and compared directly against the specified requirements of this standard for Type I - Class I dental ceramics.

8. The Sample Size for the Training Set

This information is not applicable. There is no concept of a "training set" for this type of device (dental material). The device's formulation and manufacturing processes are likely developed based on scientific principles and internal R&D, not through machine learning.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as #8.

Summary

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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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Indication for use

510(k) Number: K151731

Device Name: rainbow™ Paste Stain

Indication for use:

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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510(k) Summary

04/11/2016

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	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

The intended use of general porcelain is to make the artificial teeth (dental prosthesis) more similar

510(k) Summary

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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

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, Na2CO3K2CO3, Li2CO3, CaCO3ZnO, etc.	Feldspar, Na2CO3, Al2O3,CaCO3, K2CO3, BaCO3,etc.	SimilarThe subject and predicatedevice both have feldspar andseveral oxides as the majorcomponent.
Form	Paste	Powder + Liquid	SimilarThe subject device ispre-mixture of powder andliquid for ease of use
Type, class ofdental ceramic	Type I - Class I	Type I - Class I	Same
Sterilization	Non-sterile	Non-sterile	Similar
Indication for use	rainbowTM Paste Stain isindicated for use as aveneering material forfixed prosthesis in crownsand bridges. This device isused in prostheticdentistry by forming aporcelain veneer on to aceramic substructure.	Vita VM® porcelains areindicated for use as aveneering material forfixed prosthesis in crowns,bridges, and dentalimplant abutments. Thesedevices are used inprosthetic dentistry byforming a porcelainveneer on to a ceramic ormetal substructure into theshape of a dental crown.	The predicate device hasseveral proprietary names(VM7, VM9, VM11, VM13)The subject device and VitaVM9 are used to veneer overthe ceramic substructure(denatl core)Vita VM7 is applicable toalumina substructures.Vita VM9 is applicable tozirconia substructures.Vita VM11 is applicable tolithium silicate substructures.Vita VM13 is applicable togold or metal substructures.
Use	Prescription	Prescription	Same
Technical characteristics
Bending Strength(Flexural strength)	79 MPa	approx. 100 MPa	Flexural strength islower, but higherthan required byISO 6872:2008 forClass I dental ceramics(> 50 MPa).
Chemical Solubility(µg/cm2)	24	approx. 10	Chemical solubilitysatisfies requirement byISO 6872:2008 forClass I dental ceramics(< 100µg/cm2).
Linear thermalexpansioncoefficient	$(9.5±0.5) x 10-6K-1$	$(9.0 ~ 9.2) x 10-6K-1$	Similar
Glass transitiontemperature	476 °C	approx. 600 °C	The subject and predicatedevice have each firingschedule reflecting these twotechnological characteristics
Biocompatibility	Biocompatible	Biocompatible	Same

Comparison of Characteristics

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510(K) Number: K151731

There are three minor differences that are worth discussing:

The differences of 'Indication for use' are not critical to the intended use. The general

510(k) Summary

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intended use of porcelain like subject and predicate device is to make the artificial teeth (dental prosthesis) more similar with natural teeth by building up porcelains on the dental coping made of zirconia or metal.

1. The subject and predicate device have slight difference in composition. But they both have feldspar and several oxides as the major component. This difference has no effect on substantial equivalence of the device. The non-clinical tests (bench test and biocompatibility test) demonstrate the Technical characteristics.
1. The differences of flexural strength and chemical solubility are within what is expected of this type of device. The performance test results satisfy the requirement for Type I - Class I dental ceramic by ISO 6872:2008.

The subject and predicate device have each firing schedule reflecting the linear thermal expansion coefficient and glass transition temperature.

7. Summary of non-clinical testing

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	- Linear thermal expansion coefficient
- Chemical Solubility	- 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)

510(k) Summary

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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™ Paste Stain is substantially equivalent to the 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.