RAINBOW BLOCK

K092513 · Genoss Co., Ltd. · EIH · Oct 9, 2009 · Dental

Device Facts

• Record ID: K092513
• Device Name: RAINBOW BLOCK
• Applicant: Genoss Co., Ltd.
• Product Code: EIH · Dental
• Decision Date: Oct 9, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

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.

Device Story

Rainbow Block is a zirconia-based dental ceramic material. It is supplied as a block intended for milling into dental cores using MAD/MAM or CAD/CAM systems. Following the milling process, the core is fired in a furnace to achieve sintering and hardening of the ZrO2 material. Once hardened, the core is layered with porcelain to create a finished dental prosthesis. The device is used in dental laboratory settings by dental technicians. The output is a structural dental core that serves as the foundation for a final restoration, benefiting patients by providing a durable, biocompatible framework for dental prosthetics.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and performance were established through biocompatibility and product validation testing.

Technological Characteristics

Material: Zirconia (ZrO2). Form factor: Milled block for dental cores. Processing: Machine milling (MAD/MAM or CAD/CAM) followed by furnace sintering. Biocompatibility: Tested per applicable international and US regulations.

Indications for Use

Indicated for the manufacture of dental cores via machine milling (MAD/MAM or CAD/CAM) and subsequent sintering for dental prostheses.

Regulatory Classification

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.

Predicate Devices

• Zirkonzahn Ice (K061851)
• Ceramill Zi Blank (K063511)

Submission Summary (Full Text)

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K0925/3

**GENOSS**

OCT - 9 2009

## 510(k) Summary

30th June, 2009

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## 1. Company

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| | Submitter |
|----------------|------------------------------------------------------------------------------------------------|
| Name | Genoss Co., Ltd. |
| Address | Gyeonggi R&DB Center 1F, 906-5 lui-dong, Suwon-si Yeongtong-gu,<br>Gyeonggi-do, 443-766, Korea |
| Phone / Fax | [phone] / [phone] |
| Contact person | Kim, Yookang / QA<br>[e-mail] |

### 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

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.

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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 [phone]. 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 [phone] or [phone] 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