(143 days)
Not Found
No
The summary describes a dental material (zirconia blanks) used with CAD/CAM technology, but there is no mention of AI or ML being used in the material itself or the manufacturing process described. The performance studies focus on material properties, not algorithmic performance.
No
The device is a material used for constructing dental restorations, not a therapeutic device itself.
No
The document describes dental blanks for creating crowns, copings, and bridges, which are restorative devices, not diagnostic devices used for identifying diseases or conditions.
No
The device description clearly states it is a y-tzp (yttria stabilized tetragonal zirconia polycrystals) material, which is a physical material used in dental restorations, 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 the construction of dental restorations (crowns, copings, inlays, fixed partial dentures). This is a structural and restorative purpose, not for diagnosing a disease or condition.
- Device Description: The description focuses on the material properties (zirconia) and its use in CAD/CAM technology for creating dental prosthetics.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the human body (blood, urine, tissue, etc.) or to provide information for diagnosis, monitoring, or treatment decisions based on such analysis.
- Performance Studies: The performance studies described relate to the mechanical and chemical properties of the material, not its ability to detect or measure biological markers.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device is a material used to create a physical restoration for the mouth.
N/A
Intended Use / Indications for Use
InSync ZR High Translucency Zirconia blanks are intended for use in construction of dental crowns, copings, inlays, and fixed partial dentures up to 3 units. While primarily intended for full contour crowns and bridges, it is also suitable for copings and substructures.
Product codes
EIH
Device Description
InSync ZR High Translucency Zirconia is a y-tzp (yttria stabilized tetragonal zirconia polycrystals) material that features very high translucency. It is intended for use in construction of dental crowns, copings, inlays, and fixed partial dentures up to 3 units using CAD/CAM technology. While primarily intended for full contour crowns and bridges, it is also suitable for copings and substructures. InSync ZR High Translucency Zirconia meets requirements for Class 5 (type II) ceramics when tested according to ISO 6872:2008.
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
Non-clinical testing was performed to confirm adherence to the mechanical and chemical properties required of ISO 6872:2008 as a Class 5 (type II) ceramic including flexural strength and chemical solubility.
Zircona has a long track record in the medical and dental space because of its strength, chemical stability and high biocompatability. InSync Zr High Translucency Zirconia follows numerous other dental ziconias to market, including the predicate device, that have established a strong product history that has been formally reported upon favorably in various clinical studies.
Key Metrics
Not Found
Predicate Device(s)
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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18,2014
Jensen Industries, Inc. Jordan Schreck Quality Manager 50 Stillman Road North Haven, CT 06473
Re: K142043
Trade/Device Name: InSync ZR High Translucency Zirconia Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: October 9, 2014 Received: October 10, 2014
Dear Mr. Schreck:
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.
1
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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,
Susan Runyan DDS, MA
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
2
Section C:
Indications for Use
510(k) Number (if known):
Device Name: InSync ZR High Translucency Zirconia
Indications for Use: InSync ZR High Translucency Zirconia blanks are intended for use in construction of dental crowns, copings, inlays, and fixed partial dentures up to 3 units. While primarily intended for full contour crowns and bridges, it is also suitable for copings and substructures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINF-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
Section D:
K142043
510(k) Summary
| Submitted by: | Jensen Industries, Inc.
50 Stillman Road
North Haven, CT. 06473 USA
(203) 239-2090 phone
(203) 285-2990 fax
Contact: Jordan Schreck |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | July 18, 2014 |
| Device Name: | InSync ZR High Translucency Zirconia |
| Common Name: | Dental Ceramic |
| Classification Name: | Porcelain powder for clinical use (21 CFR 872.6660) |
| Classification: | Class II |
| Product Code: | EIH |
| Predicate Device | NexxZr T; 510(k) number: K130991 |
Device Description
InSync ZR High Translucency Zirconia is a y-tzp (yttria stabilized tetragonal zirconia polycrystals) material that features very high translucency. It is intended for use in construction of dental crowns, copings, inlays, and fixed partial dentures up to 3 units using CAD/CAM technology. While primarily intended for full contour crowns and bridges, it is also suitable for copings and substructures. InSync ZR High Translucency Zirconia meets requirements for Class 5 (type II) ceramics when tested according to ISO 6872:2008.
Indications for Use
InSync ZR High Translucency Zirconia bianks are intended for use in construction of dental crowns, copings, inlays, and fixed partial dentures up to 3 units. While primarily intended for full contour crowns and bridges, it is also suitable for copings and substructures.
Physical Properties
Non-clinical testing was performed to confirm adherence to the mechanical and chemical properties required of ISO 6872:2008 as a Class 5 (type II) ceramic including flexural strength and chemical solubility.
Biocompatibility
Zircona has a long track record in the medical and dental space because of its strength, chemical stability and high biocompatability. InSync Zr High Translucency Zirconia follows numerous other dental ziconias to market, including the predicate device, that have established a strong product history that has been formally reported upon favorably in various clinical studies.
4
Comparison to Predicate Device
Being a Class 5 dental ceramic per ISO 6872:2008, as opposed to a Class 6 for NexxZr T, InSync ZR High Translucency Zirconia carries with it a 3 unit restriction for bridges. This change in intended use is a result of a lower flexural strength measure – a trade off to achieve higher translucency – but is in keeping with the general indications for NexxZr T and other dental zirconias on the market.
Outside of this Class related deviation, all other elements related to handling, design, mechanical properties, chemical composition, biocompatability and indications for use demonstrate InSync ZR High Translucency Zirconia to be substantially equivalent to the predicate device NexxZr T. With both materials meeting their respective non-clinical technical properties measures per ISO 6872:2008, a similar standard of safety and effectivness has been acheived.