(13 days)
Not Found
No
The summary describes polymer discs used in CAD/CAM milling for dental restorations. There is no mention of AI or ML in the intended use, device description, or performance studies. The technology described is purely material-based and manufacturing-process related.
No.
The device is a material (polymer discs) used to create dental restorations, not a device that directly provides therapy.
No
The device is described as tooth-shade polymer discs used for manufacturing dental restorations (crowns, bridges, copings) via CAD/CAM techniques, not for detecting, diagnosing, or monitoring medical conditions.
No
The device description explicitly states that the devices are "tooth-shade polymer discs based on polyether ether ketone (PEEK)" and are available in various physical forms (discs of different diameters and heights). This indicates a physical hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that these are polymer discs used for creating dental restorations like crowns, bridges, and frameworks. This is a manufacturing process for a medical device that will be placed in the body, not a test performed on a sample from the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting biomarkers or analytes.
- Providing diagnostic information about a patient's health status.
Therefore, the TECNO MED and TECNO MED MINERAL devices are dental materials used in the fabrication of prosthetics, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
TECNO MED MINERAL, TECNO MED MINERAL DENTINE and TECNO MED MINERAL TISSUE are used to create reduced crowns and bridges (max. 2 pontics and 13 mm² connection cross-section), telescopic primary crowns, copings as well as frameworks for composite veneered bridges. The width of the bridge must not exceed two pontics for reasons of stability.
TECNO MED is designed for the manufacturing of frictional elements on telescopic restorations or attachments.
Product codes (comma separated list FDA assigned to the subject device)
EBF, EBI
Device Description
Tecno Med and the three Tecno Med Mineral devices are tooth-shade polymer discs based on polyether ether ketone (PEEK). These discs are available in a variety of shapes for different milling systems. For each device, there are two diameter variants, 95 mm and 98 mm. The discs with a diameter of 98 mm are additionally available with or without step. Moreover, each model is provided in different heights (8mm-30 mm). The users can choose according to their requirements and preferences among the different models. Tecno Med Mineral, Tecno Med Mineral Dentine as well as Tecno Med Mineral Tissue have the same indications for use, for the Tecno Med device there are other indications for use.
These polymer discs are used by specifically trained personnel using CAD/CAM techniques.
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
specifically trained personnel
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical testing was performed to determine the physical properties of the subject devices. In consideration of the International Standard ISO 10993-1, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing, the subject devices were tested to evaluate: In-vitro cytotoxicity, Skin sensitization, Irritation, Mutagenicity. Biocompatibility testing demonstrated that no issue of biocompatibility arises. Furthermore, on the subject devices testing according to ISO 10477:2004 and DIN EN ISO 20795-2:2013 were performed. All test samples meet the requirements set by the standards. The results of nonclinical tests demonstrate that the devices are equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Zirkonzahn Srl % Mark Job Official Correspondent Regulatory Technology Services, LLC 1394 25th Street, Nw Buffalo, Minnesota 55313
June 18,2018
Re: K181484
Trade/Device Name: Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: June 1, 2018 Received: June 5, 2018
Dear Mark Job:
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.
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 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);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mary S. Runner -S
forTina Kiang, Ph.D. Acting 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) K181484
Device Name
Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue
Indications for Use (Describe)
TECNO MED MINERAL, TECNO MED MINERAL DENTINE and TECNO MED MINERAL TISSUE are used to create reduced crowns and bridges (max. 2 pontics and min. 13 mm² connection cross-section), telescopic primary crowns, copings as well as frameworks for composite veneered bridges. The width of the bridge must not exceed two pontics for reasons of stability.
TECNO MED is designed for the manufacturing of frictional elements on telescopic restorations or attachments.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the logo for Zirkonzahn, a company specializing in human zirconium technology. The logo features the word "Zirkonzahn" in a bold, sans-serif font, with the "ahn" portion set against a black background. Below the company name, the tagline "Human Zirconium Technology" is written in a smaller, italicized font. The logo is simple, modern, and professional.
5. 510(k) Summary K181484
Date of summary: 2018-05-18
SUBMITTER: ZIRKONZAHN Srl Gewerbegebiet - Zona Industriale an der Ahr 7 Gais, ITALY 39030 Phone: +39 0474 066 660 Fax: +39 0474 066 661 E-mail: info@zirkonzahn.com
- CONTACT PERSON: Sandra Leitner Phone: +39 0474 066 784 E-Mail: Sandra.leitner@zironzahn.com
Device Name
Proprietary Name: Tecno Med Mineral, Tecno Med Mineral Dentine,
Tecno Med Mineral Tissue
Common Name: Dental Polymer Discs
Classification
Review Panel: Dental Device Class: II Product Code: EBF Subsequent Product Code: EBI Classification Name: material, tooth shade, resin Requlation Number: 872.3690
Predicate Device
Already cleared device selected to demonstrate substantial equivalence: Company: Bredent GmbH & Co. KG Predicate Device Name: breCAM.BioHPP 510(k) Number: K152113 Product Code: EBF Subsequent Product Code: EBI Class: II
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Image /page/4/Picture/0 description: The image shows the Zirkonzahn logo, which is a combination of text and a graphic. The text "Human Zirconium Technology" is located below the logo. The image also contains the text "PREMARKET NOTIFICATION 510(k)" on the right side.
Device Description
Tecno Med and the three Tecno Med Mineral devices are tooth-shade polymer discs based on polyether ether ketone (PEEK). These discs are available in a variety of shapes for different milling systems. For each device, there are two diameter variants, 95 mm and 98 mm. The discs with a diameter of 98 mm are additionally available with or without step. Moreover, each model is provided in different heights (8mm-30 mm). The users can choose according to their requirements and preferences among the different models. Tecno Med Mineral, Tecno Med Mineral Dentine as well as Tecno Med Mineral Tissue have the same indications for use, for the Tecno Med device there are other indications for use.
These polymer discs are used by specifically trained personnel using CAD/CAM techniques.
Indications for use
TECNO MED is designed for the manufacturing of frictional elements on telescopic restorations or attachments.
TECNO MED MINERAL, TECNO MED MINERAL DENTINE and TECNO MED MINERAL TISSUE are used to create reduced crowns and bridges (max. 2 pontics and 13 mm² connection cross-section), telescopic primary crowns, copings as well as frameworks for composite veneered bridges. The width of the bridge must not exceed two pontics for reasons of stability.
Technological Characteristics and substantial equivalence
Chemical composition:
The new devices as well as the predicate devices are based on PEEK, therefore they are similar in their chemical composition.
Indications for use:
The indications for use of the new and predicate devices are similar.
Intended user:
The subject devices as well as the predicate devices are intended to be further processed by specifically trained personnel.
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Image /page/5/Picture/1 description: The image shows the logo for Zirkonzahn, a company that specializes in human zirconium technology. The logo is composed of two words, "Zirkon" and "zahn", with the first word in white letters and the second word in white letters on a black background. Below the logo is the tagline "Human Zirconium Technology" in a smaller font.
Non-clinical performance:
Non clinical testing was performed to determine the physical properties of the subject devices. In consideration of the International Standard ISO 10993-1, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing, the subject devices were tested to evaluate: In-vitro cytotoxicity, Skin sensitization, Irritation, Mutagenicity. Biocompatibility testing demonstrated that no issue of biocompatibility arises. Furthermore, on the subject devices testing according to ISO 10477:2004 and DIN EN ISO 20795-2:2013 were performed. All test samples meet the requirements set by the standards.
The results of nonclinical tests demonstrate that the devices are equivalent to the predicate device.
| | NEW DEVICES | | | | PREDICATE
DEVICE |
|------------------------------------------------------|-------------------------|------------------------------------|-----------------------------------|----------------|---------------------|
| Trade
Name | Tecno
Med
Mineral | Tecno
Med
Mineral
Dentine | Tecno
Med
Mineral
Tissue | Tecno
Med | breCAM.BioHPP |
| Shades | White | Dentine | Tissue | Natural | White &
Dentine |
| Melting
Temperatur
e | Approx. 340 °C | | | | Approx. 340 °C |
| Water
absorption
(according to
10477:2004) | 7.3
µg/mm³ | 6.5
µg/mm³ | 7.2
µg/mm³ | 4.73
µg/mm³ | 6.5 µg/mm³ |
| Water
solubility
(according to
10477:2004) | 1.2
µg/mm³ | 0.6
µg/mm³ | 1.2
µg/mm³ | 1.67
µg/mm³ | 0.1 µg/mm³ |
| Density | 1.49
g/cm³ | 1.52
g/cm³ | 1.36
g/cm³ | 1.31
g/cm³ | 1.44 g/cm³ |
| Modulus of
elasticity | 4100 MPa | 4400 MPa | 5100 MPa | ≥ 4300
MPa | 4585 MPa |
| Flexural
strength
(according to
10477:2004) | 201 MPa | 198 MPa | 189 MPa | 174 MPa | 178 MPa |
| Biocompati
bility
(according to
ISO 10993) | Established | | | | Established |
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Image /page/6/Picture/1 description: The image shows the logo for Zirkonzahn. The logo is in black and white, with the word "Zirkonzahn" in a bold, sans-serif font. Below the logo is the text "Human Zirconium Technology" in a smaller, serif font. The logo is simple and modern, and it conveys a sense of quality and innovation.
The Zirkonzahn devices as well as the breCAM.BioHPP device are available as milling blanks. These blanks can be obtained in different shapes for different milling systems, different heights and different dental shades. Zirkonzahn provides a broader range of color shades as Bredent. This difference results from the fact that Zirkonzahn wants to provide to the customer a broader range of options. The specifically trained staff may choose among them, according to the aesthetic requirements.
The subject device and the predicate device meet the requirements of the applicable ISO standards and show similar results.
The test data shown above indicate that the subject devices are substantially equivalent to the predicate device.
Conclusion
The new devices of Zirkonzahn srl are substantially equivalent to the cleared predicate device as they are similar in their indications for use, material, technology, design and performance specifications.