CERAMAX

K062504 · Alphadent Co., Ltd. · EIH · Sep 5, 2006 · Dental

Device Facts

• Record ID: K062504
• Device Name: CERAMAX
• Applicant: Alphadent Co., Ltd.
• Product Code: EIH · Dental
• Decision Date: Sep 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

CeraMax is indicated for veneering of metal framework and copings for the preparation of crowns and bridges.

Device Story

CeraMax is a dental ceramic system consisting of porcelain powders (Feldspar, Quartz, metal oxides, and pigments) used to create prosthetic crowns and bridges. Dental technicians apply the material in layers—including opaque, dentine, enamel, translucent, cervical, glaze, and stain—onto metal frameworks. The applied layers are fired in a high-temperature furnace to produce a hard, glass-like finish that mimics natural tooth color and structure. The device is used in dental laboratories by technicians to fabricate custom prosthetics for patients requiring dental restoration.

Clinical Evidence

Bench testing only. Performance properties, including physical characteristics, glass transition temperature, flexural strength, and chemical solubility, were verified to conform to ISO 9693 and ISO 6872 standards. Biocompatibility was determined to be equivalent to legally marketed devices based on material composition.

Technological Characteristics

Composition: Feldspar, Quartz (SiO3), Al2O3, K2CO3, Na2CO3, SnO2, ZrO2, CeO2, Li2CO3, BaCO3, CaCO3, H3BO3, and pigments. Form: Powder (for mixing with liquid) or paste. Standards: Conforms to ISO 9693 and ISO 6872. Processing: High-temperature furnace firing. Layers: Opaque, Dentine, Enamel, Translucent, Cervical, Glaze, Stain.

Indications for Use

Indicated for veneering of metal frameworks and copings in the fabrication of dental crowns and bridges.

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

• DUCERAM PLUS CERAMIC SYSTEM (K040420)

Submission Summary (Full Text)

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K 062304

AlphaDent 371 37, Gasan-Dong, Geumcheon-Gu, Seoul, Republic of Korea 153-803 Phone: [phone] Fax [phone] Email: alphadent(@alphadent.co.kr

## 510(k) Summary

SEP - 5 2006

Date: June 10, 2006

1. Company making the submission:

| | Submitter |
|----------|-----------------------------------------------------------------------|
| Name | Alphadent Co., Ltd. |
| Address | 371-37, Gasan-Dong, Geumcheon-Gu,<br>Seoul, Republic of Korea 153-803 |
| Phone | [phone] |
| Fax | [phone] |
| Contact | Mr. Noh Hak |
| Internet | http://www.alphadent.co.kr |

#### 2. Device :

Proprietary Name - CeraMax Common Name - Dental Ceramic Classification Name - Porcelain powder for clinical use

## 3. Predicate Device: DUCERAM PLUS CERAMIC SYSTEM, Porcelain powders Dentsply International Company. K040420.

### 4. Description :

CeraMax is a dental material product composed of Feldspar, Quartz (SiO3), A1/O1, K-CO3, Na2CO1. SnO2 ZrO2 CeO2 LinCO2, BaCO1, CaCO2, H2BO3 and color pigments including Fluorolumin. It consists of Opaque (including Powder opaque, Paste opaque and Opaque modifier), Dentine (including Dentine modifier and Opacious Dentine), Enamel, Translucent, Cervical, Glaze and Stain. They are used by dental technicians for the preparation of crowns and bridges. It is used in prosthetic dentisty by heating the powder mixture to a high temperature in a furnace to produce a hard prosthesis with a glass-like finish.

- 5. Indication for use :
CeraMax is indicated for veneering of metal framework and copings for the preparation of crowns and bridges.

6. Review :

CeraMax has the similar technological characteristics to the predicate device; components, indication for use, chemical and performance properties.

#### Components Similarities

Both products are supplied as a powder for mixing together with a liguid to form a paste or as a paste to apply for thinner and easier usage. Both products are supplied with different layers i.e.: Opaque, Dentine and Enamel etc., that have different name. However they functionally are same

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# AlphaDent

371-37, Gasan-Dong, Geumcheon-Gu, Seoul, Republic of Korea 153-803 Phone: [phone] Fax: [phone] Email: [e-mail]

in order to replicate different color layers in a natural tooth. These layers are built up and fired in a furnace in the similar order and at similar temperature.

Indication for Use Similarities Both products have the similar indication for use.

### Chemical Similarities

Both products are made up of porcelain powders and are used in a dental ceramic veneering system of metal framework and copings to form an enamel porcelain layer. They are supplied with different layers i.e .: Opaque, Dentine, Enamel etc. in order to replicate different color layers in a natural tooth. They fall within the same class and have a product code.

## Performance Properties Similarities

Both products have essentially the similar firing characteristics including starting temperature, drying time, tinal temperature and requirement of vacuum. They also manufactured, conforming ISO 9693, ISO 6872. These standards specify performance criteria such as physical properties, glass transition temperature, flexural strength and chemical solubility so that the results of performance meet the requirements of the international standard in accordance with ISO 9693 and ISO 6872.

Blocompatibility of CeraMax is similar to the legally marketed devices and has not changed to occur adverse effects of biocompatibility. Therefore, it was determined that no additional biocompatibility testing was necessary.

Therefore, we believe that CeraMax is substantially equivalent to predicated device according to the above information in terms of component, indication for use, chemical and performance priorities.

#### 7. Conclusions :

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

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP - 5 2006

Alphadent Company, Limited C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Incorporated 2600 North West Lake Road Camas, Washington 98607-9526

Re: K062504

Trade/Device Name: CeraMax Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: August 16, 2006 Received: August 28, 2006

Dear Mr. Mouser:

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 such 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 - Mr. Mouser

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours,

Seritte y Michael Omo.

Chíu Lin, Ph.D. 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

(1/2574

510(k) Number (if known)

Device Name: CeraMax

Indications for Use:

CeraMax is indicated for veneering of metal framework and copings for the preparation of crowns and bridges.

Prescription Use_ AND/OR Over-The-Counter Use (21CFR801 Subpart D) (21CFR801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

) Number:

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