(8 days)
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No
The description focuses solely on the material composition and intended use of a dental ceramic system, with no mention of software, algorithms, or any AI/ML related terms.
No
Explanation: CeraMax is a dental material used for veneering metal frameworks and copings to prepare crowns and bridges. It is a material used in the creation of prosthetic devices, not a therapeutic device itself.
No
Explanation: The device, CeraMax, is a dental material used for veneering metal frameworks in crowns and bridges, which is a therapeutic or restorative purpose, not for diagnosing medical conditions.
No
The device description clearly states that CeraMax is a dental material product composed of various chemical compounds and powders, which are physical substances used in the preparation of crowns and bridges. This indicates it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "veneering of metal framework and copings for the preparation of crowns and bridges." This describes a material used in the fabrication of dental prosthetics, which are devices implanted or placed in the body.
- Device Description: The description details the chemical composition and forms of a dental material used by dental technicians to create crowns and bridges through a heating process. This is a manufacturing process for a medical device.
- Lack of Diagnostic Purpose: There is no mention of this device being used to test samples from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
IVD devices are specifically designed to perform tests in vitro (outside the body) on biological specimens to provide diagnostic information. CeraMax is a material used to construct a medical device (a dental prosthesis) that will be used in vivo (in the body).
N/A
Intended Use / Indications for Use
CeraMax is indicated for veneering of metal framework and copings for the preparation of crowns and bridges.
Product codes
EIH
Device 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Dental technicians for the preparation of crowns and bridges. Prosthetic dentistry.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. Biocompatibility 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
K 062304
AlphaDent 371 37, Gasan-Dong, Geumcheon-Gu, Seoul, Republic of Korea 153-803 Phone: 482-2 837-4840 Fax +82 2 837-8732 Email: alphadent(@alphadent.co.kr
510(k) Summary
SEP - 5 2006
Date: June 10, 2006
- Company making the submission:
| Submitter | |
|---|---|
| Name | Alphadent Co., Ltd. |
| Address | 371-37, Gasan-Dong, Geumcheon-Gu, |
| Seoul, Republic of Korea 153-803 | |
| Phone | +82 2 837-4840 |
| Fax | +82 2 837-8732 |
| 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.
-
- Indication for use :
CeraMax is indicated for veneering of metal framework and copings for the preparation of crowns and bridges.
- Indication for use :
- 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
1
AlphaDent
371-37, Gasan-Dong, Geumcheon-Gu, Seoul, Republic of Korea 153-803 Phone: +82-2 837-4840 Fax: +82 2 837-8732 Email: alphadent@alphadent.co.kr
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.
2
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.
3
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
4
...
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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