Erran Dental Zirconia

K182068 · Hangzhou Erran Technology Co., Ltd. · EIH · Dec 13, 2018 · Dental

Device Facts

• Record ID: K182068
• Device Name: Erran Dental Zirconia
• Applicant: Hangzhou Erran Technology Co., Ltd.
• Product Code: EIH · Dental
• Decision Date: Dec 13, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Erran Dental Zirconia are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facing, and veneers.

Device Story

Erran Dental Zirconia consists of zirconia-based ceramic blocks and powder used by dental professionals or laboratories to fabricate all-ceramic dental restorations, including crowns, bridges, veneers, and inlays/onlays. The device is derived from yttria-stabilized tetragonal zirconia (Y-TZP) powder. Blocks are pre-formed; powder is used to directly shape teeth. The material is sintered to achieve final mechanical properties. The device serves as a restorative material to replace missing or damaged tooth structure, benefiting patients by providing durable, biocompatible prosthetic teeth. It is a single-use, non-sterile material processed in a dental laboratory setting.

Clinical Evidence

Bench testing only. Performance verified against ISO 6872-2015 (Dentistry: Ceramic Materials) and ISO 13356-2015 (Implants for Surgery-Ceramic Materials). Biocompatibility testing conducted per ISO 7405-2008 and ISO 10993-10, including cytotoxicity, mucosal irritation, and sensitization. All test results met acceptance criteria.

Technological Characteristics

Material: Yttria-stabilized tetragonal zirconia (ZrO2+Y2O3+HfO2+Al2O3) conforming to ISO 13356-2015. Form factor: Cuboid blocks, cylindrical blocks, and powder. Sintering temperature: 1350-1600°C. Post-sintering density: >6.02 g/cm³. Fracture toughness: >800 MPa. Elastic modulus: 210 GPa. Porosity: 0%.

Indications for Use

Indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facing, and veneers.

Regulatory Classification

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.

Predicate Devices

• Aidite Zirconia Dental Ceramics (K111291)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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

1. 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 [e-mail] Tel: [phone] (China) 1-360 216 1286 (USA) Fax: [phone]

#### 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;<br>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<br>Composition(%) | Meet the ISO 13356-2015 | ZrO2+HfO2 ≥99<br>+Y2O3<br>Y2O3 4.5~6.6<br>HfO2 ≤5<br>Al2O3 ≤0.5<br>SiO2 ≤0.3<br>Fe2O3 ≤0.2 | Meet the<br>ISO<br>13356-2015 |
| Appearance | There is no spot cracks and<br>foreign matter on the surface<br>of Erran Dental Zirconia. | There is no spot cracks and<br>foreign matter on the<br>surface of Erran Dental<br>Zirconia. | Conform |
| Size(mm) | The size deviation of<br>zirconia blocks is within<br>1.0mm.<br>The weight deviation of<br>zirconia powder is within<br>10g. | Meet the requirement. | Conform |
| Density (g/cm³) | Not less than 2.6, the<br>deviation is less than 0.05<br>compared with marked<br>value(3.16). | Meet the requirement. | Conform |
| Sintering<br>density<br>(g/cm³) | Not less than 6.02 | 6.025 | Conform |
| Fracture<br>Toughness (post<br>sintering)<br>(MPa) | At least 8 samples of the 10<br>samples have a fracture<br>toughness greater than 800 | The samples met the<br>criteria. | Conform |
| Chemical<br>solubility<br>(µg/cm²) | <100 | 12.42 | Conform |
| Shrinkage | At least 8 samples of the 10<br>samples have a Shrinkage<br>which should between<br>19~27 | Average is 19.61, all<br>samples are between 19 - 27<br>range. | Conform |
| Mixing<br>and<br>condensation<br>properties(only<br>for<br>zirconia<br>powder) | After the zirconia powder is<br>compacted, it should not be<br>cracked or broken, and after<br>forming compaction, it may<br>not be agglomerated. | The samples meet the<br>requirements. | Conform |
| The coefficient<br>of thermal<br>expansion (only<br>for<br>zirconia<br>powder) | $6.5 × 10^{-6} K^{-1}~11.5 × 10^{-6}$<br>$K^{-1}$ , the deviation is less<br>than $0.5 × 10^{-6} K^{-1}$ | $10.5 × 10^{-6} K^{-1}$ | Conform |
| Radioactivity | The activity concentration of<br>U-238 is not more than 1.0 | <0.005 | Conform |
| Cytotoxicity<br>Irritation Oral<br>Mucosa<br>Irritation<br>Sensitization<br>Subacute<br>Subchronic<br>Toxicity<br>Genotoxicity | Biocompatibility testing<br>including cytotoxicity,<br>mucosal irritation,<br>sensitization conducted in<br>accordance with ISO<br>7405-2008 and ISO<br>10993-10. | We conducted comparative<br>performance testing for<br>biocompatibility testing<br>including cytotoxicity,<br>mucosal irritation,<br>sensitization and etc.<br>conducted in accordance<br>with ISO 7405-2008 and<br>ISO 10993-10, and meet the<br>requirements. | 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 Zirconia<br>K182068 | Predicate Device<br>K111291 | Comparison |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Indication for<br>use | Erran Dental Zirconia<br>Blocks are indicated for the<br>production of artificial teeth<br>in fixed or removable<br>dentures, or for jacket<br>crowns, facing, and veneers.<br>All Blocks are processed<br>thought dental laboratories<br>or by dental professionals. | Aidite Zirconia Dental<br>Ceramics are indicated for<br>the production of artificial<br>teeth in fixed or removable<br>dentures, or for jacket<br>crowns, facing, and<br>veneers. All Blanks are<br>processed thought dental<br>laboratories or by dental<br>professionals. | Same |
| Single Use | Yes | Yes | Same |
| Color | None | None, and Pre-shaded (for<br>Pre-shaded series) | Different, Does<br>not affect the<br>use of the<br>product |
| Type<br>Specification | Blocks, powder | Blocks, disc, and rod | Different, Does<br>not affect the<br>use of the<br>product |
| Materials | Zirconia(ZrO2+Y2O3+HfO2≥<br>99.0%) | Zirconia(ZrO2+Y2O3+HfO2<br>+Al2O3≥99.0%) | Different, Does<br>not affect the<br>use of the<br>product |
| Crystal<br>Morphology | Tetragonal | Tetragonal | Same |
| Porosity | 0% | 0% | Same |
| Sintering<br>temperature | 1350-1600°C | 1480°C | Different |
| Density (pre<br>sintering) | $3.10g/cm^3$ | $3.10g/cm^3$ | Same |
| Density (post<br>sintering) | $>6.02g/cm^3$ | $6.05g/cm^3$ | Different, Does<br>not affect the<br>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<br>Toughness (pre<br>sintering) | 55Mpa | 55Mpa | Same |
| Bending<br>strength | > 800MPa; | > 800MPa; | Same |
| Shrinkage | 19%-27% | 22.00% | Different, Does<br>not affect the<br>use of the<br>product |
| Elastic modulus<br>(post sintering) | 210Gpa | 210Gpa | Same |
| Porosity | 0% | 0% | Same |
| Chemical<br>solubility | <100µg/cm² | <100µg/cm² | Same |
| Radioactive | The activity concentration of<br>U-238is not more than 1.0. | The activity concentration<br>of U-238is not more than<br>1.0. | Same |
| Cytotoxicity<br>Irritation Oral<br>Mucosa<br>Irritation<br>Sensitization<br>Subacute<br>Subchronic<br>Toxicity<br>Genotoxicity | We conducted comparative<br>performance testing for<br>biocompatibility testing<br>including cytotoxicity,<br>mucosal irritation,<br>sensitization and etc.<br>conducted in accordance<br>with ISO 7405-2008 and ISO<br>10993-10, and meet the<br>requirements. | No biocompatibility testing<br>provided 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.