(134 days)
Not Found
No
The device description focuses on the material composition and physical form of dental zirconia, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies described are standard bench testing for material properties.
No
The device is a material (zirconia blocks and powder) used to produce dental restorations, not a device that provides therapy.
No
The device is a material (zirconia blocks and powder) used for the production of artificial teeth, which are used as a restorative solution rather than for diagnosing a condition.
No
The device description clearly states that the device is offered in physical forms (blocks and powder) and is composed of specific materials (ZrO2+Y2O3+HfO2+Al2O3). It is a physical material used for creating dental restorations, not a software application.
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 production of artificial teeth in fixed or removable dentures, jacket crowns, facings, and veneers. This is a direct medical device used for restoration and prosthetics within the mouth.
- Device Description: The device is described as zirconia blocks and powder used to fabricate dental restorations. This is a material used in the manufacturing process of a medical device, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Testing: The testing described focuses on the material properties and biocompatibility of the zirconia, not on 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 diagnostic information. This device is a material used to create dental prosthetics, which falls under the category of a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
Erran Dental Zirconia are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facing, and veneers.
Product codes
EIH
Device Description
Normally, Erran Dental Zirconia are offered in blocks and powder and the size as shown below in Table 5-1, and are similar to the sizes and shapes of the predicate device.
There are two types of our device, one is block, another is powder. The main difference is that the blocks are made by powder, zirconia blocks is prepared and have a fixed shape, while zirconia powder is used to directly product the shape of the tooth.
Erran Dental Zirconia are derived from Zirconia powder that has been processed into their final net shapes. Erran Dental Zirconia have are then being further fabricated in to all-ceramic restoration such as crowns, bridge, veneers, inlay/onlay. The zirconia powder is composed of ZrO2+Y2O3+HfO2+Al2O3 with its composition conforms to ISO13356-2015, Implants for Surgery-Ceramic Materials Based in Yttria-Stabilized Tetragonal Zirconia(Y-TZP). The performance of the dental zirconia conforms to ISO 6872-2015, Dentistry: Ceramic Materials.
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
All Blocks are processed thought dental laboratories or by dental professionals.
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)
Bench testing was performed per ISO 6872-2015 and internal procedures to ensure that the Erran Dental Zirconia met its specification. All tests were verified to meet acceptance criteria. Biocompatibility testing was performed to verify the equivalent safety of the materials that are used.
Tests were conducted following the recommended procedures outline in the FDA recognized consensus standard of ISO 6872-2015, ISO7405-2008 and ISO 10993-1-2009, and results meet all relevant requirements in the test standards.
Key results:
- Chemical Composition(%): Meet the ISO 13356-2015
- Appearance: There is no spot cracks and foreign matter on the surface of Erran Dental Zirconia.
- Size(mm): Meet the requirement.
- Density (g/cm³): Meet the requirement.
- Sintering density (g/cm³): 6.025 (Not less than 6.02)
- Fracture Toughness (post sintering) (MPa): The samples met the criteria. (At least 8 samples of the 10 samples have a fracture toughness greater than 800)
- Chemical solubility (µg/cm²): 12.42 (
§ 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
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December 13, 2018
Hangzhou Erran Technology Co., Ltd. Tingkai Li Chief Technology Officer Room F3022, Floor 3, Building 1 (south) No. 368 Liuhe Road Hangzhou, 310053 Cn
Re: K182068
Trade/Device Name: Erran Dental Zirconia Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: July 28, 2018 Received: August 1, 2018
Dear Tingkai Li:
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.htm); 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 Digitally signed by Mary S.
Runner -s3 -S3 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 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) K182068
Device Name Erran Dental Zirconia
Indications for Use (Describe)
Erran Dental Zirconia are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facing, and veneers.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image contains the logo of Hangzhou Erran Technology Co., Ltd. The logo consists of a blue square with a green circle inside, and a horizontal green line across the middle of the circle. To the right of the logo is the company name, "Hangzhou Erran Technology Co.,Ltd" in black text.
510(k) Summary K182068
- Date
August 28, 2018
2. Submitter
Hangzhou Erran Technology Co.,Ltd. Room F3022, Floor 3, Building 1 (south)No. 368 Liuhe Road, Binjiang District Hangzhou, 310053 zhejiang, china
3. Official contact person
Tingkai Li Chief Technology Officer tingkai.li@errantech.com Tel: +86-15968174962 (China) 1-360 216 1286 (USA) Fax: +86-571-88055546
4. Product information
Proprietary Name Erran Dental Zirconia
Common Name Dental Zirconia Ceramics
Classification Name (Number) Procelain powder for clinical use (872.6660)
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Image /page/4/Picture/0 description: The image shows the logo of Hangzhou Erran Technology Co., Ltd, which features a blue and green icon. Below the company name, it states "Proposed Regulatory Class" followed by "Class II". The text is in a clear, readable font, and the overall layout is simple and professional.
Product Code EIH
Predicate Devices Aidite Zirconia Dental Ceramics (K111291)
5. Device Description
Normally, Erran Dental Zirconia are offered in blocks and powder and the size as shown below in Table 5-1, and are similar to the sizes and shapes of the predicate device.
There are two types of our device, one is block, another is powder. The main difference is that the blocks are made by powder, zirconia blocks is prepared and have a fixed shape, while zirconia powder is used to directly product the shape of the tooth.
Erran Dental Zirconia are derived from Zirconia powder that has been processed into their final net shapes. Erran Dental Zirconia have are then being further fabricated in to all-ceramic restoration such as crowns, bridge, veneers, inlay/onlay. The zirconia powder is composed of ZrO2+Y2O3+HfO2+Al2O3 with its composition conforms to ISO13356-2015, Implants for Surgery-Ceramic Materials Based in Yttria-Stabilized Tetragonal Zirconia(Y-TZP). The performance of the dental zirconia conforms to ISO 6872-2015, Dentistry: Ceramic Materials.
| Model (Device size, unit: mm) | |
|---|---|
| Cuboid blocks | (Length - width - height, unit: mm) 20-14-15; 20-19-15; |
| 40-14-15 | |
| Cylindrical blocks | (Diameter - Thickness, unit: mm) D15-16; D18-14; D98-14 |
| Powder | (Weight, unit: g) 60 |
Table 5-1 The normal model of Erran Dental Zirconia
6. Indications for Use
Erran Dental Zirconia are intended for use for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facing, and veneers.
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Image /page/5/Picture/0 description: The image contains the logo for Hangzhou Erran Technology Co., Ltd. The logo features a stylized letter "E" formed by a blue rectangle and a green semi-circle. The text "Hangzhou Erran Technology Co.,Ltd" is written in black, with the company name following the logo. The text is aligned to the right of the logo.
7. Summary of Device Testing
Bench testing was performed per ISO 6872-2015 and interal procedures to ensure that the Erran Dental Zirconia met its specification. All tests were verified to meet acceptance criteria. Biocompatibility testing was performed to verify the equivalent safety of the materials that are used.
The following table 5-2 shows test requirement and result of our device. Tests were conducted following the recommended procedures outline in the FDA recognized consensus standard of ISO 6872-2015, ISO7405-2008 and ISO 10993-1-2009, and results meet all relevant requirements in the test standards.
| Item | The Requirements | Result | Conclusion |
|---|---|---|---|
| Chemical | |||
| Composition(%) | Meet the ISO 13356-2015 | ZrO2+HfO2 ≥99 | |
| +Y2O3 | |||
| Y2O3 4.5~6.6 | |||
| HfO2 ≤5 | |||
| Al2O3 ≤0.5 | |||
| SiO2 ≤0.3 | |||
| Fe2O3 ≤0.2 | Meet the | ||
| ISO | |||
| 13356-2015 | |||
| Appearance | There is no spot cracks and | ||
| foreign matter on the surface | |||
| of Erran Dental Zirconia. | There is no spot cracks and | ||
| foreign matter on the | |||
| surface of Erran Dental | |||
| Zirconia. | Conform | ||
| Size(mm) | The size deviation of | ||
| zirconia blocks is within | |||
| 1.0mm. | |||
| The weight deviation of | |||
| zirconia powder is within | |||
| 10g. | Meet the requirement. | Conform | |
| Density (g/cm³) | Not less than 2.6, the | ||
| deviation is less than 0.05 | |||
| compared with marked | |||
| value(3.16). | Meet the requirement. | Conform | |
| Sintering | |||
| density | |||
| (g/cm³) | Not less than 6.02 | 6.025 | Conform |
| Fracture | |||
| Toughness (post | |||
| sintering) | |||
| (MPa) | At least 8 samples of the 10 | ||
| samples have a fracture | |||
| toughness greater than 800 | The samples met the | ||
| criteria. | Conform | ||
| Chemical | |||
| solubility | |||
| (µg/cm²) | 6.02g/cm^3$ | $6.05g/cm^3$ | Different, Does |
| not affect the | |||
| use of the |
| Table 5-3 Comparison to Predicate Device(Zirconia Dental Ceramic) | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | ------------------------------------------------------------------- |
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Image /page/8/Picture/0 description: The image shows a logo with a blue square in the background. A green circle is in the foreground, partially overlapping the blue square. A horizontal blue line runs through the center of the green circle and the blue square.
Hangzhou Erran Technology Co.,Ltd
| product | |||
|---|---|---|---|
| Fracture | |||
| Toughness (pre | |||
| sintering) | 55Mpa | 55Mpa | Same |
| Bending | |||
| strength | > 800MPa; | > 800MPa; | Same |
| Shrinkage | 19%-27% | 22.00% | Different, Does |
| not affect the | |||
| use of the | |||
| product | |||
| Elastic modulus | |||
| (post sintering) | 210Gpa | 210Gpa | Same |
| Porosity | 0% | 0% | Same |
| Chemical | |||
| solubility |