(135 days)
No
The 510(k) summary describes a material (zirconia blanks) used for fabricating dental restorations. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The focus is on the material properties and intended uses for dental prosthetics.
No
The device is described as blanks used for fabricating dental restorations (crowns and bridges), which are prosthetics and not therapeutic devices.
No
The device is a material used for fabricating dental restorations, not for diagnosing medical conditions.
No
The device description clearly states that the device is made of "pre-sintered zirconia materials," indicating 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 fabricating dental restorations (crowns and bridges). This is a medical device used for treatment and restoration within the body, not for diagnosing conditions based on in vitro examination of samples.
- Device Description: The device is a material (zirconia blanks) used to create physical dental prosthetics. It doesn't interact with biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device falls under the category of dental materials used for restorative purposes, which are classified as medical devices, not IVDs.
N/A
Intended Use / Indications for Use
VITA YZ® ST and VITA YZ® XT materials are blanks used for fabricating dental restorations.
VITA YZ® ST is indicated for fully anatomical anterior crowns, multi-unit fully anatomical anterior and posterior bridges, fully anatomical crowns and multi-unit bridges on direct screw-retained restorations, and single-tooth and multi-unit bridge frameworks of anterior and posterior crowns and bridges.
VITA YZ® XT is indicated for fully anatomical anterior and posterior crowns, fully anatomical 3-unit anterior and posterior bridges, and anterior and posterior single-tooth and 3-unit bridge frameworks.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
VITA YZ ST and VITA YZ XT discs are pre-sintered zirconia materials, partially stabilized with yttrium oxide (Y-TZP, yttria stabilized tetragonal zirconia polycrystal). VITA YZ ST is made of Super Translucent Zirconia and VITA YZ XT is made of Extra Translucent Zirconia. They offer higher translucency to better match natural dentition.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing:
VITA YZ ST and VITA YZ XT were tested and met the requirements of the following standards:
- ISO 6872:2015 – Dentistry, Ceramic materials
- EN ISO 9693-2:2016 - Dentistry, Compatibility Testing, Ceramic-ceramic systems
Bench test results allowed us to conclude that VITA YZ ST and VITA YZ XT meet their intended use.
Biocompatibility:
VITA YZ ST and VITA YZ XT meet biocompatibility requirements of the following standards:
- ISO 10933-1:2009 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
- ISO 7405:2008 Dentistry - Evaluation of Biocompatibility of Medical Devices Used in Dentistry
Clinical Performance Data:
Not applicable. No human clinical testing was performed to support the substantial equivalence of VITA YZ ST and VITA YZ XT.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural Strength:
VITA YZ ST 934 ± 104 MPa
VITA YZ XT 678 ± 62 MPa
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.
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
§ 872.6660 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 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and below that, the word "ADMINISTRATION" in a smaller font, also in blue.
August 1, 2018
VITA Zahnfabrik H.Rauter GmbH Co. % Nevine Erian Director, Regulatory Affairs & Compliance (Consultant) VITA North America 22705 Savi Ranch Parkway, Suite 100 Yorba Linda, California 92887
Re: K180703
Trade/Device Name: VITA YZ ST and VITA YZ XT Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: May 30, 2018 Received: May 31, 2018
Dear Nevine Erian:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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
For Tina 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
2
Indications for Use
510(k) Number (if known)
Device Name
VITA YZ® ST and VITA YZ® XT
Indications for Use (Describe)
VITA YZ® ST and VITA YZ® XT materials are blanks used for fabricating dental restorations.
VITA YZ® ST is indicated for fully anatomical anterior crowns, multi-unit fully anatomical anterior and posterior bridges, fully anatomical crowns and multi-unit bridges on direct screw-retained restorations, and single-tooth and multi-unit bridge frameworks of anterior and posterior crowns and bridges.
VITA YZ® XT is indicated for fully anatomical anterior and posterior crowns, fully anatomical 3-unit anterior and posterior bridges, and anterior and posterior single-tooth and 3-unit bridge frameworks.
| 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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3
510(k) Summary
| Submitter | VITA Zahnfabrik H.Rauter GmbH Co.
Spitelgasse 3
Bad Sackingen, D-79713
Germany
Establishment Reg. No. 1000625496 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Bernd Walker
Head of Regulatory Affairs and Quality Systems
Phone (+49) 7761 562-361
Fax (+49) 7761 562-384
B.Walker@vita-zahnfabrik.com |
| Official Correspondent | Nevine Erian
Director, Regulatory Affairs & Compliance (Consultant)
VITA North America, Inc.
22705 Savi Ranch Parkway, Suite 100
Yorba Linda, CA 92887
Establishment Reg. No. 2082832
Phone (949) 370-7155
Fax (714) 221-6759
E-mail: nerian@vitanorthamerica.com |
| Date Prepared | May 29, 2018 |
- Trade/Device Name VITA YZ® ST and VITA YZ® XT 트
- Common Name Zirconia Based , CAD/CAM Material ■
- 트 Classification Name Porcelain powder for clinical use
- . Regulation Number 21 CFR 872.6660
- . Product Code EIH
Predicate Devices
VITA In–CERAM YZ Cubes for CEREC® (VITA Zahnfabrik GmbH) – K022996 – Primary Predicate
4
priti® multidisc Zr02 High Translucent ( pritidenta GmbH) – K161025 – Reference Predicate
Device Description
VITA YZ ST and VITA YZ XT discs are pre-sintered zirconia materials, partially stabilized with yttrium oxide (Y-TZP, yttria stabilized tetragonal zirconia polycrystal). VITA YZ ST is made of Super Translucent Zirconia and VITA YZ XT is made of Extra Translucent Zirconia. They offer higher translucency to better match natural dentition.
Statement of Intended Use
VITA YZ® ST and VITA YZ® XT materials are blanks used for fabricating dental restorations.
VITA YZ ST is indicated for fully anatomical anterior and posterior crowns, multi-unit fully anatomical anterior and posterior bridges, fully anatomical crowns and multi-unit bridges on direct screw-retained restorations, and single-tooth and multi-unit bridge frameworks of anterior and posterior crowns and bridges.
VITA YZ XT is indicated for fully anatomical anterior and posterior crowns, fully anatomical 3-unit anterior and posterior bridges, and anterior and posterior single-tooth and 3-unit bridge frameworks.
Material Composition
VITA YZ ST and YZ XT are formulated with yttrium-stabilized zirconia which is identical to the predicate device VITA YZ T (KO22996). VITA YZ ST and VITA YZ XT have higher amounts of yttrium, for increased translucency, compared to VITA YZ T.
Technological Characteristics
VITA YZ products are offered in disc and block configurations, in different shades. Blocks have a mandrel attachment, to permit securing into a CAD/CAM machine for milling into a restoration.
Non-Clinical Performance Testing
VITA YZ ST and VITA YZ XT were tested and met the requirements of the following standards:
- . ISO 6872:2015 – Dentistry, Ceramic materials
- EN ISO 9693-2:2016 - Dentistry, Compatibility Testing, Ceramic-ceramic systems
5
Bench test results allowed us to conclude that VITA YZ ST and VITA YZ XT meet their intended use.
Biocompatibility
VITA YZ ST and VITA YZ XT meet biocompatibility requirements of the following standards:
- i ISO 10933-1:2009 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
- . ISO 7405:2008 Dentistry - Evaluation of Biocompatibility of Medical Devices Used in Dentistry
Clinical Performance Data
Not applicable. No human clinical testing was performed to support the substantial equivalence of VITA YZ ST and VITA YZ XT.
Substantial Equivalence
Material
VITA YZ ST and YZ XT are similar in chemical composition as the predicate devices.
Physical Properties
VITA YZ ST and YZ XT have similar physical properties as the predicate devices.
Technical Comparison of VITA YZ ST and YZ XT to Predicate Devices
| Technical Attribute | VITA YZ ST and XT | VITA IN-
CERAM YZ
(Primary
Predicate) | priti® multidisc
Zr02 HT
(Reference
Predicate) |
|--------------------------------------------------------------------------------------------|----------------------|------------------------------------------------|---------------------------------------------------------|
| Indications | | | |
| Fully anatomical anterior and
posterior crowns | ST – Yes
XT – Yes | Yes | Yes |
| Multi-unit fully anatomical
anterior and posterior bridges | ST – Yes
XT – Yes | Yes | Yes |
| Fully anatomical crowns and
multi-unit bridges on direct
screw-retained restorations | ST – Yes
XT – No | Yes | Yes |
6
| Technical Attribute | VITA YZ ST and XT | VITA IN-
CERAM YZ
(Primary
Predicate) | priti® multidisc
Zr02 HT
(Reference
Predicate) |
|------------------------------------------------------------------------------------------------------|-----------------------------------------------------|------------------------------------------------|---------------------------------------------------------|
| Single-tooth and multi-unit
bridge frameworks of anterior
and posterior crowns and
bridges. | ST - Yes
XT - Yes | Yes | Yes |
| Fully anatomical 3-unit
anterior and posterior bridges | ST - Yes
XT - Yes | Yes | Yes |
| Anterior and posterior single-
tooth and 3-unit bridge
frameworks | ST - Yes
XT - Yes | Yes | Yes |
| CAD/CAM Material | Yes | Yes | Yes |
| Physical Configuration | Disc Form | Disc & Block
Form | Disc & Block Form |
| Shades | Different shades | Different
shades | Different shades |
| Meets ISO 6872 Req'ts | Yes | Yes | Yes |
| Flexural Strength | VITA YZ ST 934 ± 104 MPa
VITA YZ XT 678 ± 62 MPa | 1165 ± 56 MPa | > 650 MPa |
Conclusion
Information provided in this application demonstrates that VITA YZ ST and VITA YZ XT are substantially equivalent in safety and effectiveness to the predicate devices. VITA YZ ST & VITA YZ XT have similar indications for use, similar material composition, similar physical properties, and similar technological characteristics as VITA In-CERAM YZ Cubes for CEREC® and priti® multidisc Zr02 HT. The differences between VITA YZ ST & VITA YZ XT and the predicate devices do not impact safety and effectiveness, as VITA YZ ST & VITA YZ XT share same indications as the predicate devices, meet the same biocompatibility, and ISO 6872 test criteria.