(476 days)
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No
The summary describes a dental material blank for CAD/CAM processing, with no mention of AI or ML in its function or processing.
No.
The device is a restorative material for dental prostheses and not intended for treating a disease or condition.
No
Explanation: This device is described as a material for fabricating dental restorations (crowns, bridges, inlays, onlays, veneers), which is a treatment or restorative function, not a diagnostic one.
No
The device is a physical blank made of composite material reinforced with zirconium dioxide, intended for processing with CAD/CAM technology to create dental restorations. It is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a material for creating dental restorations (crowns, bridges, inlays, onlays, veneers). These are devices used in the body or on the body, not for testing samples from the body.
- Device Description: The description confirms it's a material for dental fabrication.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
Tizian Blank Zirconia Reinforced Composite is made of a composite material reinforced with zirconium dioxide. The blanks can be processed with CAD/CAM technology. Optionally, the blanks can be veneered with a composite or with a monolithic material. Applications are:
-
- long-term temporaries (for up to 2 years)
- up to 16-unit anterior and posterior crowns and bridges, fully anatomic or reduced o
- only up to 2 bridge units in the posterior sector o
- free-end bridges with no more than one attachment O
-
- small permanent restorations (those must be veneered with an incisal material)
- individual crowns o
- o inlavs
- onlays O
- veneers o
- bridges with a maximum of 3 units. O
Product codes
EBG
Device Description
Tizian Blank Zirconia Reinforced Composite is made of a composite material reinforced with zirconium dioxide. The blanks can be processed with CAD/CAM technology. Optionally, the blanks can be veneered with a composite or with a monolithic material.
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
Prescription Use (21 CFR Part 801 Subpart D)
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a family of three figures, with the top figure representing the head, the middle figure representing the body, and the bottom figure representing the legs.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2015
Schuetz Dental GmbH Mrs. Anke Puent Secretary Dieselstr. 5-6 61191 Rosbach GERMANY
Re: K133268
Trade/Device Name: Tizian Blank Zirconia Reinforced Composite Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Codes: EBG Dated: November 13, 2014 Received: November 17, 2014
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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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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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Tina Kiang
-s
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K133268
Device Name: Tizian Blank Zirconia Reinforced Composite Indications for Use:
Tizian Blank Zirconia Reinforced Composite is made of a composite material reinforced with zirconium dioxide. The blanks can be processed with CAD/CAM technology. Optionally, the blanks can be veneered with a composite or with a monolithic material. Applications are:
-
- long-term temporaries (for up to 2 years)
- up to 16-unit anterior and posterior crowns and bridges, fully anatomic or reduced o
- only up to 2 bridge units in the posterior sector o
- free-end bridges with no more than one attachment O
-
- small permanent restorations (those must be veneered with an incisal material)
- individual crowns o
- o inlavs
- onlays O
- veneers o
- bridges with a maximum of 3 units. O
Prescription Use X (21 CFR Part 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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