(137 days)
Not Found
Not Found
No
The summary describes dental materials (ceramic and zirconium dioxide blanks) and their intended use in dental restorations. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The description focuses on the material properties and processing methods (copy milling, CAD/CAM), which are standard dental laboratory techniques.
No
The device is a material used for dental restorations (ceramic coating, crowns, bridges), which is a device component rather than a therapeutic device that directly treats a condition.
No
Explanation: The provided text describes dental materials (glass ceramic and zirconium dioxide) used for coatings, crowns, bridges, and inlays. It does not mention any function related to diagnosing a disease, condition, or state of health.
No
The device description clearly states it is a glass ceramic material and zirconium dioxide blanks, which are physical materials, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The description clearly states that Tizian Ceramic and Tizian Zr Blanks are materials used for creating dental restorations (coatings, crowns, bridges, inlays). They are materials that become part of a medical device (the dental restoration), not devices used to test or analyze biological samples.
- The intended use is for dental restoration. The text describes the materials' purpose in creating dental prosthetics, which are implanted or placed in the mouth. This is a different category of medical device than an IVD.
The description focuses on the material composition and its use in manufacturing dental devices, not on analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
Tizian Ceramic is a glass ceramic material, colored to match the VITAPAN® color system. It is used for the ceramic coating of titanium and titanium alloys as well as zirconium dioxide-based frame materials.
Tizian Zr Blanks are produced of yttrium oxide-stabilized tetragonal zirconium dioxide in several different sizes for the production of full ceramic crowns, bridges and inlays.
Product codes
EIH
Device Description
Tizian Ceramic is a glass ceramic material, colored to match the VITAPAN® color system. It is used for the ceramic coating of titanium and titanium alloys as well as zirconium dioxide-based frame materials. Tizian guarantees an easy and reliable treatment without the need for long-term cooling.
Opaques for titanium and titanium alloys are prepared as follows: No additional bonder is necessary, as the opaque's unique structural condition already acts as a seal for the titanium suface. A strong and reliable bond is created between the metal and the dental ceramics material. The opaque liguid is added to the opaque powder and mixed until the desired consistency is reached. A thin layer of opaquer is applied so that almost the entire surface is coated after the first opaque firing. Best results are achieved when coating approximately 70 % of the metal frame material. This optimum surface area must be reached by the end of the second opaque firing. After firing the opaque appears shiny.
The shoulder material is applied to the shoulders of the rough-textured material in a thin laver insulating it. The required shoulder material powder and liquid is mixed to the shoulder. It is riffled lightly until solid, excess liquid is extracted and the material is dried thoroughly.
A number of different liners for zirconium oxide frames ensures that the correct tooth colorant is already applied to the zirconium oxide frame during the first processing step. The liner is mixed with the modelling liquid to the desired consistency, then it is applied evenly onto the frame. If second liner firing is necessary, the above process must be repeated.
To ensure that the colorant stabilizes from within the material, it is recommended to apply opaque dentin in numerous layers to a smaller tooth form. The opaque dentin, dentin, incisal and transparent mixtures are mixed with modelling fluid to the desired consistency. Then, they are applied in small amounts to the cervical and interndental areas and vibrated lightly until solid. Next, the desired mixtures are applied in layers to the tooth surface. Once this has been done, the solidifying process is stopped and the material is cleaned carefully, removing any loose particles with a suction extractor. If further firings are required, the above process is repeated.
When using glazing materials or stains, they are mixed with the paint liquid to the desired consistency, then applied to the ceramic surface.
Tizian Zr Blanks are composed of tetragonal zirconium dioxide stabilized with yttrium oxide. They are available in different sizes and permit the production of ceramic crowns and bridges. The material is partially sintered and can be processed using copy milling as well as CAD/CAM procedures.
The blanks are suited to the production of primary conus and telescope crowns, crown and bridge worksin front and side tooth areas, abufments and inlays.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/0 description: The image shows the logo for "Schütz Dental Group" with a figure of a man kneeling and holding a tool. Below the logo, there is a handwritten code "K071010". The logo is in black and white and appears to be a scan or photocopy.
Premarket Notification 510(k) - 510(k) Summary
AUG 2 4 2007
Tizian Ceramic
Tizian Ceramic is a glass ceramic material, colored to match the VITAPAN® color system. It is used for the ceramic coating of titanium and titanium alloys as well as zirconium dioxide-based frame materials. Tizian guarantees an easy and reliable treatment without the need for long-term cooling.
Opaques for titanium and titanium alloys are prepared as follows: No additional bonder is necessary, as the opaque's unique structural condition already acts as a seal for the titanium suface. A strong and reliable bond is created between the metal and the dental ceramics material. The opaque liguid is added to the opaque powder and mixed until the desired consistency is reached. A thin layer of opaquer is applied so that almost the entire surface is coated after the first opaque firing. Best results are achieved when coating approximately 70 % of the metal frame material. This optimum surface area must be reached by the end of the second opaque firing. After firing the opaque appears shiny.
The shoulder material is applied to the shoulders of the rough-textured material in a thin laver insulating it. The required shoulder material powder and liquid is mixed to the shoulder. It is riffled lightly until solid, excess liquid is extracted and the material is dried thoroughly.
A number of different liners for zirconium oxide frames ensures that the correct tooth colorant is already applied to the zirconium oxide frame during the first processing step. The liner is mixed with the modelling liquid to the desired consistency, then it is applied evenly onto the frame. If second liner firing is necessary, the above process must be repeated.
To ensure that the colorant stabilizes from within the material, it is recommended to apply opaque dentin in numerous layers to a smaller tooth form. The opaque dentin, dentin, incisal and transparent mixtures are mixed with modelling fluid to the desired consistency. Then, they are applied in small amounts to the cervical and interndental areas and vibrated lightly until solid. Next, the desired mixtures are applied in layers to the tooth surface. Once this has been done, the solidifying process is stopped and the material is cleaned carefully, removing any loose particles with a suction extractor. If further firings are required, the above process is repeated.
When using glazing materials or stains, they are mixed with the paint liquid to the desired consistency, then applied to the ceramic surface.
1
Image /page/1/Picture/0 description: The image shows the logo for "Schütz Dental Group". The logo features the company name in a bold, sans-serif font, with the word "Schütz" appearing larger than "Dental Group". To the right of the name is a stylized graphic of a person kneeling and holding a dental instrument. The overall design is simple and professional, conveying a sense of reliability and expertise.
Tizian Zr Blanks
Tizian Blanks are composed of tetragonal zirconium dioxide stabilized with yttrium oxide. They are available in different sizes and permit the production of ceramic crowns and bridges. The material is partially sintered and can be processed using copy milling as well as CAD/CAM procedures.
The blanks are suited to the production of primary conus and telescope crowns, crown and bridge worksin front and side tooth areas, abufments and inlays.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles three overlapping human profiles or abstract shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Anke Puent Assistant Schütz-Dental GmbH Dieselstrasse 5-6 Rosbach, Hessen, GERMANY 61191
AUG 2 4 2007
Re: K071010
Trade/Device Name: Tizian Ceramic and Tizian Zr Blanks Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: August 1, 2007 Received: August 3, 2007
Dear Ms. Puent:
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 -- Ms. Puant
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 yours,
Sylte y. Michie MD.
Chiu 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
510(k) Number (if known): K071010 Device Name: Tizian_ Indications for Use:
Tizian Ceramic is a glass ceramic material, colored to match the VITAPAN® color system. It is used for the ceramic coating of titanium and titanium alloys as well as zirconium dioxide-based frame materials.
Tizian Zr Blanks are produced of yttrium oxide-stabilized tetragonal zirconium dioxide in several different sizes for the production of full ceramic crowns, bridges and inlays.
× Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)
Susan Runge
(Division Sign-Off)
(Civision Olym-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices and of Anesthesion of Anesthesiology, Gene
Infection Control, Dental Devices
510(k) Number: KC771010