(134 days)
Erran Dental Zirconia are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facing, and veneers.
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.
The provided text describes the acceptance criteria and a study conducted for the Erran Dental Zirconia device. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Item | Acceptance Criteria | Reported Device Performance | 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) | <100 | 12.42 | Conform |
| Shrinkage | At least 8 samples of the 10 samples have a Shrinkage which should between 19~27 | Average is 19.61, all samples are between 19-27 range. | Conform |
| Mixing and Condensation Properties (only for zirconia powder) | After the zirconia powder is compacted, it should not be cracked or broken, and after forming compaction, it may not be agglomerated. | The samples meet the requirements. | Conform |
| The coefficient of thermal expansion (only for zirconia powder) | $6.5 × 10^{-6} K^{-1}~11.5 × 10^{-6} K^{-1}$, the deviation is less than $0.5 × 10^{-6} K^{-1}$ | $10.5 × 10^{-6} K^{-1}$ | Conform |
| Radioactivity | The activity concentration of U-238 is not more than 1.0 | <0.005 | Conform |
| Biocompatibility (Cytotoxicity, Irritation Oral Mucosa, Irritation, Sensitization, Subacute, Subchronic Toxicity, Genotoxicity) | Biocompatibility testing including cytotoxicity, mucosal irritation, sensitization conducted in accordance with ISO 7405-2008 and ISO 10993-10. | We conducted comparative performance testing for biocompatibility testing including cytotoxicity, mucosal irritation, sensitization and etc. conducted in accordance with ISO 7405-2008 and ISO 10993-10, and meet the requirements. | Conform |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set Sample Size: For "Fracture Toughness" and "Shrinkage," the criteria specify "At least 8 samples of the 10 samples," implying a sample size of 10 for these specific tests. Other tests do not explicitly state a sample size, but the results indicate that they were performed.
- Data Provenance: The document states "Bench testing was performed per ISO 6872-2015 and internal procedures." It also mentions "Biocompatibility testing was performed to verify the equivalent safety of the materials that are used." There is no information provided regarding the country of origin of the data or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The study involves bench testing and biocompatibility testing based on recognized international standards (ISO 6872-2015, ISO 7405-2008, ISO 10993-1-2009). For these types of tests, "ground truth" is typically established by fulfilling the requirements and methodologies outlined in the respective standards, rather than expert consensus on clinical cases. Therefore, information about the number or qualifications of experts establishing ground truth in the context of clinical interpretation is not applicable here. The "experts" would be the scientists and technicians conducting the standardized tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a study based on physical and chemical bench testing and biocompatibility assessment against established standards, not a clinical study requiring adjudication of expert interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device, but rather a dental material (zirconia) whose performance is evaluated through material science and biocompatibility tests.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a dental material, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this study is defined by the acceptance criteria specified in internationally recognized standards for dental materials, specifically ISO 6872-2015 (Dentistry: Ceramic Materials) and ISO 13356-2015 (Implants for Surgery-Ceramic Materials Based in Yttria-Stabilized Tetragonal Zirconia). For biocompatibility, ISO 7405-2008 and ISO 10993-10 were used. The device performance is measured against these quantitative and qualitative requirements.
8. The sample size for the training set
Not applicable. This is a material testing study, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device and study.
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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
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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
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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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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 |
|---|---|---|---|
| ChemicalComposition(%) | Meet the ISO 13356-2015 | ZrO2+HfO2 ≥99+Y2O3Y2O3 4.5~6.6HfO2 ≤5Al2O3 ≤0.5SiO2 ≤0.3Fe2O3 ≤0.2 | Meet theISO13356-2015 |
| Appearance | There is no spot cracks andforeign matter on the surfaceof Erran Dental Zirconia. | There is no spot cracks andforeign matter on thesurface of Erran DentalZirconia. | Conform |
| Size(mm) | The size deviation ofzirconia blocks is within1.0mm.The weight deviation ofzirconia powder is within10g. | Meet the requirement. | Conform |
| Density (g/cm³) | Not less than 2.6, thedeviation is less than 0.05compared with markedvalue(3.16). | Meet the requirement. | Conform |
| Sinteringdensity(g/cm³) | Not less than 6.02 | 6.025 | Conform |
| FractureToughness (postsintering)(MPa) | At least 8 samples of the 10samples have a fracturetoughness greater than 800 | The samples met thecriteria. | Conform |
| Chemicalsolubility(µg/cm²) | <100 | 12.42 | Conform |
| Shrinkage | At least 8 samples of the 10samples have a Shrinkagewhich should between19~27 | Average is 19.61, allsamples are between 19 - 27range. | Conform |
| Mixingandcondensationproperties(onlyforzirconiapowder) | After the zirconia powder iscompacted, it should not becracked or broken, and afterforming compaction, it maynot be agglomerated. | The samples meet therequirements. | Conform |
| The coefficientof thermalexpansion (onlyforzirconiapowder) | $6.5 × 10^{-6} K^{-1}~11.5 × 10^{-6}$$K^{-1}$ , the deviation is lessthan $0.5 × 10^{-6} K^{-1}$ | $10.5 × 10^{-6} K^{-1}$ | Conform |
| Radioactivity | The activity concentration ofU-238 is not more than 1.0 | <0.005 | Conform |
| CytotoxicityIrritation OralMucosaIrritationSensitizationSubacuteSubchronicToxicityGenotoxicity | Biocompatibility testingincluding cytotoxicity,mucosal irritation,sensitization conducted inaccordance with ISO7405-2008 and ISO10993-10. | We conducted comparativeperformance testing forbiocompatibility testingincluding cytotoxicity,mucosal irritation,sensitization and etc.conducted in accordancewith ISO 7405-2008 andISO 10993-10, and meet therequirements. | Conform |
Table 5-2 Test summary table
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Image /page/6/Picture/0 description: The image shows a logo with a blue square containing a stylized letter 'E'. The 'E' is formed by a green semi-circle overlapping a white shape, creating the impression of the letter. The logo is simple and modern, using a combination of geometric shapes and contrasting colors.
Hangzhou Erran Technology Co.,Ltd
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Image /page/7/Picture/0 description: The image contains the logo of Hangzhou Erran Technology Co., Ltd. The logo features a stylized letter 'E' formed by blue and green shapes. The company name is written in a clear, sans-serif font to the right of the logo.
8. Comparison to Predicate Device
The following table 5-3 shows similarities and differences of use, design, and the materials between our device and the predicate devices.
| Description | Erran Dental ZirconiaK182068 | Predicate DeviceK111291 | Comparison |
|---|---|---|---|
| Indication foruse | Erran Dental ZirconiaBlocks are indicated for theproduction of artificial teethin fixed or removabledentures, or for jacketcrowns, facing, and veneers.All Blocks are processedthought dental laboratoriesor by dental professionals. | Aidite Zirconia DentalCeramics are indicated forthe production of artificialteeth in fixed or removabledentures, or for jacketcrowns, facing, andveneers. All Blanks areprocessed thought dentallaboratories or by dentalprofessionals. | Same |
| Single Use | Yes | Yes | Same |
| Color | None | None, and Pre-shaded (forPre-shaded series) | Different, Doesnot affect theuse of theproduct |
| TypeSpecification | Blocks, powder | Blocks, disc, and rod | Different, Doesnot affect theuse of theproduct |
| Materials | Zirconia(ZrO2+Y2O3+HfO2≥99.0%) | Zirconia(ZrO2+Y2O3+HfO2+Al2O3≥99.0%) | Different, Doesnot affect theuse of theproduct |
| CrystalMorphology | Tetragonal | Tetragonal | Same |
| Porosity | 0% | 0% | Same |
| Sinteringtemperature | 1350-1600°C | 1480°C | Different |
| Density (presintering) | $3.10g/cm^3$ | $3.10g/cm^3$ | Same |
| Density (postsintering) | $>6.02g/cm^3$ | $6.05g/cm^3$ | Different, Doesnot affect theuse 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 | |||
|---|---|---|---|
| FractureToughness (presintering) | 55Mpa | 55Mpa | Same |
| Bendingstrength | > 800MPa; | > 800MPa; | Same |
| Shrinkage | 19%-27% | 22.00% | Different, Doesnot affect theuse of theproduct |
| Elastic modulus(post sintering) | 210Gpa | 210Gpa | Same |
| Porosity | 0% | 0% | Same |
| Chemicalsolubility | <100µg/cm² | <100µg/cm² | Same |
| Radioactive | The activity concentration ofU-238is not more than 1.0. | The activity concentrationof U-238is not more than1.0. | Same |
| CytotoxicityIrritation OralMucosaIrritationSensitizationSubacuteSubchronicToxicityGenotoxicity | We conducted comparativeperformance testing forbiocompatibility testingincluding cytotoxicity,mucosal irritation,sensitization and etc.conducted in accordancewith ISO 7405-2008 and ISO10993-10, and meet therequirements. | No biocompatibility testingprovided in the submission | Different |
Erran Dental Zirconia meets the requirement per ISO6872-2015 and ISO7405-2015. Its performance meets the requirements of its predefined acceptance criteria and intended use, and results are also comparable to the predicate device as evidenced in comparative performance testing.
9. Substantial Equivalence Conclusion
Bases upon technology, indications for use, and non-clinical performance testing, Erran Dental Zirconia Blocks is substantially equivalent to Aidite Zirconia Dental Ceramics K111291.
§ 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.