Rainbow Block is a dental ceramic made out of zirconia. Rainbow Block is milled into cores for teeth and then is fired in the furnace to harden of ZrO2. Then the core is layered with porcelain to make a finished tooth.

AI/ML Overview

The provided text is a 510(k) summary for the "Rainbow Block" dental ceramic material. This summary focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a study that proves a device meets specific acceptance criteria in the way a diagnostic AI or medical imaging device might be evaluated for performance.

Therefore, the requested information cannot be fully provided as the "Rainbow Block" is a dental material, and its evaluation process (as described in the 510(k) summary) does not involve the types of studies typically associated with AI-driven diagnostic tools or medical devices that have performance metrics like sensitivity, specificity, or reader agreement.

However, based on the principle of substantial equivalence, we can infer some "acceptance criteria" and the "study" that implicitly proves them.

Inferred Acceptance Criteria and Device Performance (based on Substantial Equivalence):

Acceptance Criteria (Inferred)	Reported Device Performance
Material Composition	Zirconia-based ceramic, similar to predicate devices.
Indication for Use	"Used in the manufacture of a dental core through milling by machine (MAD/MAM or CAD/CAM) followed by sintering." This matches the intended use of predicate devices.
Technological Characteristics	Similar to predicate devices in "Main material, Indication for use and design."
Biocompatibility	Performed safety tests including biocompatibility to ensure compliance with applicable International and US regulations.
Safety and Effectiveness	Concluded "safe and effective and substantially equivalent to predicate devices."

Study and Data Information (based on Substantial Equivalence):

Sample size used for the test set and the data provenance: Not applicable in the context of a dental material substantial equivalence claim. There isn't a "test set" in the sense of patient data. The evaluation relies on material science testing and comparison to predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material evaluations typically involve laboratory testing and comparison to established standards, not expert consensus on ground truth in a diagnostic sense.
Adjudication method for the test set: Not applicable.
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: Not applicable. This device is a dental material, not an AI-assisted diagnostic tool requiring human reader studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a dental material, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's acceptance is based on its material properties and performance characteristics being comparable to legally marketed predicate devices, along with demonstrating biocompatibility. This involves laboratory testing following recognized standards for dental materials.
The sample size for the training set: Not applicable. There is no training set as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

Summary of the "Study" for Substantial Equivalence:

The "study" for the Rainbow Block device, as described in the 510(k) summary, is a comparison to legally marketed predicate devices (K061851 Zirkonzahn Ice and K063511 Ceramill Zi Blank). This comparison focused on:

Technological Characteristics: Main material (zirconia), indication for use, and design. The submission asserts these are "similar."
Safety Tests: Including biocompatibility, conducted to comply with applicable International and US regulations. While the specific tests or their results are not detailed in this summary, the conclusion states they were performed.

The conclusion drawn from this comparative "study" is that the Rainbow Block is "safe and effective and substantially equivalent to predicate devices." This substantial equivalence is the basis for its market clearance by the FDA without requiring a full Premarket Approval (PMA) application, which would necessitate more extensive clinical trial data.

Summary

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K0925/3

GENOSS

OCT - 9 2009

510(k) Summary

30th June, 2009

1. Company

ﺎ ﺗ

	Submitter
Name	Genoss Co., Ltd.
Address	Gyeonggi R&DB Center 1F, 906-5 lui-dong, Suwon-si Yeongtong-gu,Gyeonggi-do, 443-766, Korea
Phone / Fax	+82 31 888 5100 / +82 31 888 5105
Contact person	Kim, Yookang / QAykkim@implantium.com

2. Device Name

Proprietary name: Rainbow Block Dental frame material for Dental prosthesis Common name: Porcelain, powder for clinical use Classification name:

3. Predicated Device

K061851	Zirkonzahn Ice
K063511	Ceramill Zi Blank

4. Description

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5. Indication for Use

Rainbow Block is used in the manufacture of a dental core through milling by machine (MAD/MAM or CAD/CAM) followed by sintering.

6. Review

Rainbow Block has the similar technological characteristics as the predicate devices; Main material, Indication for use and design.

Rainbow Block has been subjected to extensive safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.

7. Conclusions

Based on the information provided in this premarket notification of Genoss Co., Ltd. concludes that Rainbow Block is safe and effective and substantially equivalent to predicate devices as described herein.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Genoss Company, Limited C/O Dr. Eunkyung Son Dentium USA 11075 Knott Avenue, Suite A Cypress, California 90630

OCT - 9 2009

Re: K092513

Trade/Device Name: Rainbow Block Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: August 5, 2009 Received: August 17, 2009

Dear Dr. Son:

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.

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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Page 2 - Dr. Sun

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

ph for

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K692513 510(k) Number:

Device Name: Rainbow Block

Indications for Use:

Rainbow Block is used in the manufacture of a dental core through milling by machine (MAD/MAM or CAD/CAM) followed by sintering.

Prescription Use 2 (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)

Reen: Mrelof for MSR

(Division Sign-Off) ാംvision of Anesthesiology, General Hospital ction Control, Dental Devices

:10(k) Number: K092513

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.