(90 days)
No
The device description and performance studies focus on the material properties and physical characteristics of the zirconia blanks, not on any computational or analytical capabilities that would involve AI/ML. There are no mentions of image processing, AI, DNN, ML, or data sets for training/testing.
No
The device, X-cera Zirconia Blanks, are materials used to produce artificial teeth and dental prosthetics. They do not directly provide therapy or treatment to a patient.
No
Explanation: The device is described as X-cera Zirconia Blanks used for the production of artificial teeth in dentures, crowns, facings, and veneers. This is a material used for fabrication of prosthetic dental devices, not for diagnosing medical conditions.
No
The device description clearly states that the device is provided in physical forms (block, disc, cylinder shapes) and is made from zirconia powder, indicating it is a physical material, not software. The performance studies also focus on physical properties like flexural strength, density, and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers." This describes a material used to create a medical device (dental prosthetics), not a test performed on a biological sample to diagnose a condition.
- Device Description: The description details the material (zirconia powder processed into blanks) and its use in fabricating dental devices. It doesn't mention any reagents, calibrators, or other components typically associated with IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies focus on the physical and chemical properties of the material and its biocompatibility, which are relevant for a dental material, not an IVD.
In summary, the X-cera Zirconia Blanks are a material used in the manufacturing of dental prosthetics, which are medical devices, but the blanks themselves are not IVDs.
N/A
Intended Use / Indications for Use
X-cera Zirconia Blanks are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Product codes
EIH
Device Description
X-cera Zirconia Blanks are provided in either block, disc, cylinder shape and are derived from zirconia powder that has been processed via uni-axial die pressing, followed by iso-static pressing, to achieve final net shapes of uniform density and distribution. These Zirconia Blanks can be fabricated into various prosthetic dental device.
X-cera Zirconia Blanks are offered in ten(10) different product families of shapes and a multitude of different sizes as shown in Figure 1 and Table 1 and are capable of being machined into complex dental shapes using modern machining methods and are similar to the sizes and shapes of the predicate device.
Any difference in the net shapes and dimensions between X-cera Zirconia Blanks and those offered by the manufacturer of the predicate devices are incidental to the performance of the final dental prosthetic devices that will be fabricated from them.
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)
The following testing has been performed to support substantial equivalence:
- Flexural Strength Test - The test results of mean flexural strength (post sintering) comply with the ISO 6872: 2008 (≥800MPa) and product design requirement (≥900MPa).
- . Density and Apparent Porosity Test - The test results of density and apparent porosity comply with the values specified by manufacturer in the Instruction for Use.
- Shrinkage rate and Expand Rate Test - The test results of shrinkage rate and expand rate comply with the acceptance criteria.
- . Physical and chemical test - The test results comply with the ISO 6872: 2008.
- . Zirconia powder Composition Test - The test results comply with the design specifications and the values specified by manufacturer in the Instruction for Use.
- . Biocompatibility Test – Results comply with ISO 7405 and ISO 10993 including In Vitro Cytotoxicity Test, Sensitization Test, Intracutaneous Reactivity Test, Acute Systemic Test, and Genotoxicity.
The X-cera Zirconia Blanks passed all testing stated above as shown by the acceptable results obtained.
The device passed all the testing in accordance with national and international standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human profile, composed of three interconnected faces in profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 29, 2016
Shenzhen XiangTong Photoelectricity Technology Co., Ltd. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313
Re: K153767
Trade/Device Name: X-cera Zirconia Blanks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: March 9, 2016 Received: March 15, 2016
Dear Mr. 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.
1
Page 2 - Mr. Mark Job
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 vours.
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
2
Indications for Use
510(k) Number (if known) K153767
Device Name X-cera Zirconia Blanks
Indications for Use (Describe)
X-cera Zirconia Blanks are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
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
for
X-cera Zirconia Blanks
1. 510(k) Number
2. Submission Sponsor
Shenzhen XiangTong Photoelectricity Technology Co., Ltd. 2~4th floor, 1st Building, South Industrial park of Honghualing, Nanshan District, Shenzhen, China Phone: 0086-755-86001804 Fax: 0086-755-86001486 Contact: Yongqing Chen, Vice-President
3. Submission Correspondent
Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: +86-21-22815850 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Lee Fu, RAC, Senior Consultant, Regulatory Email: project.management@emergogroup.com
4. Date Prepared
03/29/2016
5. Device Identification
| Trade/Proprietary Name: | X-cera Zirconia Blanks |
|---|---|
| Common/Usual Name: | Zirconia Blocks |
| Classification Name: | Porcelain powder for clinical use |
| Classification Regulation: | 872.6660 |
| Product Code: | EIH |
| Device Class: | Class II |
| Classification Panel: | Dental Devices |
6. Legally Marketed Predicate Device(s)
Aidite Zirconia Dental Ceramics (K111291)
4
7. Device Description
X-cera Zirconia Blanks are provided in either block, disc, cylinder shape and are derived from zirconia powder that has been processed via uni-axial die pressing, followed by iso-static pressing, to achieve final net shapes of uniform density and distribution. These Zirconia Blanks can be fabricated into various prosthetic dental device.
X-cera Zirconia Blanks are offered in ten(10) different product families of shapes and a multitude of different sizes as shown in Figure 1 and Table 1 and are capable of being machined into complex dental shapes using modern machining methods and are similar to the sizes and shapes of the predicate device.
Any difference in the net shapes and dimensions between X-cera Zirconia Blanks and those offered by the manufacturer of the predicate devices are incidental to the performance of the final dental prosthetic devices that will be fabricated from them.
Image /page/4/Figure/4 description: The image shows a variety of Zirconia Blanks. There are 10 different types of Zirconia Blanks, including XS series, XQ series, XW series, XZ series, XC series, XZZ series, XO series, XK series, XA series, and XM series. The Zirconia Blanks are all white, but they come in different shapes and sizes.
Figure 1 X-cera Zirconia Blanks
| Table 2
| X-cera Zirconia Blanks Product Family(Model) | |
|---|---|
| Family(Model) | Shapes & Sizes available |
| XQ series | Cylinder: Φ22*25(mm) |
| Disc: Φ98×8(mm) | |
| XW series | Discs: Φ100×10 to Φ100×25(mm) (with 3mm protruding step) |
| XO series | Discs: Φ98×10 to 98×25(mm) (with 2mm protruding step) |
| XA series | Discs: Φ100×10 to Φ100×25(mm) (with Φ112×6mm Outer plastic ring) |
| XA series | Discs: Φ98×10 to Φ98×25(mm) (with Ø 115×10mm Outer ring) |
| XA series | Discs: Φ71×10 to Φ71×25(mm) |
| XA series | Blocks: 40×20×16 to 65×30×20(mm) |
| XA series | Blocks: 90×72×10 to 90×72×25(mm)(outer ring) |
| XK series | Discs: Φ98×10 to Φ98×25(mm) |
| XK series | Blocks: 42×16×16 to 60×25×20(mm) |
| XK series | Cylinders: Φ16×16 to Φ20×20(mm) |
| XZ series | Discs: Φ95×10 to Φ95×25(mm) |
| XZ series | Blocks: 43×25×16 to 93×75×25(mm) |
5
| Cylinders: $Φ$ 23×16 to $Φ$ 23×22(mm) | |
|---|---|
| XM series | Blocks: 43×25×16 to 75×42×22(mm) |
| XC series | Cylinders $Φ$ 25×26 to $Φ$ 25×60(mm) (with Outer plastic ring) |
| Blocks: 26×25×20 to 72×40×25(mm) (with Outer plastic ring) | |
| XS series | Blocks: 20×14×15 to 85×40×22(mm) |
| XZZ series | Discs: $Φ$ 95×10 to $Φ$ 95×25(mm) |
Note: The form of size above has two forms, one is shown in D×H and the other is L×W× H, of which, "D"means Diameter, "H"means height, "L" means length, "W" means width.
8. Indication for Use Statement
X-cera Zirconia Blanks are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
9. Substantial Equivalence Discussion
The following table compares the X-cera Zirconia Blanks to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
| Manufacturer | Shenzhen XiangTong
Photoelectricity
Technology Co., ltd. | Qinhuangdao Aidite
High-Technical Ceramics
Co. | SIGNIFICANT
DIFFERENCES |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Trade Name | X-cera Zirconia Blanks | Aidite Zirconia Dental
Ceramics | / |
| 510(k) Number | / | K111291 | / |
| Product Code | EIH | EIH | Same |
| Regulation
Number | 21 CFR 872.6660 | 21 CFR 872.6660 | Same |
| Regulation Name | Powder, Porcelain | Powder, Porcelain | Same |
| Indications for Use | are indicated for the
production of artificial
teeth in fixed or
removable dentures, or
for jacket crowns,
facings, and veneers | are indicated for the
production of artificial
teeth in fixed or
removable dentures, or
for jacket crowns,
facings, and veneers | Same |
| Directions for Use | Prescription Use | Prescription Use | Same |
| Fundamental
Scientific
Technology | Iso static pressing | Iso static pressing | Same |
| Main working
principle | Be capable of being
machined into complex
dental shapes using
modern machining | Be capable of being
machined into complex
dental shapes using
modern machining | Same |
| Manufacturer | Shenzhen XiangTong
Photoelectricity
Technology Co., ltd. | Qinhuangdao Aidite
High-Technical Ceramics
Co. | SIGNIFICANT
DIFFERENCES |
| Trade Name | X-cera Zirconia Blanks | Aidite Zirconia Dental
Ceramics | / |
| | methods | methods | |
| Applied Standards | ISO 6872
ISO 10993-1
ISO 7405 | ISO 6872
ISO 10993-1
ISO 7405 | Same |
| Main Chemical
Composition (in
mass-%) | ZrO₂ 88% ~ 96%
Y₂O₃ 4% ~10%
Al₂O₃ 4%
Al₂O₃ 1%
SiO₂