Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

K160367 · Nissin-Metec China Co., Ltd. · EIH · Jul 27, 2016 · Dental

Device Facts

• Record ID: K160367
• Device Name: Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
• Applicant: Nissin-Metec China Co., Ltd.
• Product Code: EIH · Dental
• Decision Date: Jul 27, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

Device Story

Device consists of zirconia blanks (semics, rods, blocks, discs) used as raw material for dental restorations; available in uncolored and pre-shaded configurations. Dental professionals or laboratories process blanks using CAD/CAM or manual milling machines to fabricate artificial teeth, crowns, facings, or veneers. Final restorations are intended for permanent contact (>30 days) within the oral cavity. Device provides a biocompatible, high-strength ceramic material for restorative dentistry; benefits include durability and aesthetic customization through pre-shading.

Clinical Evidence

No clinical data included. Substantial equivalence supported by bench testing per ISO 6872 (flexural strength, density, thermal expansion, chemical solubility, radioactivity) and biocompatibility testing per ISO 10993 (cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, and genotoxicity).

Technological Characteristics

Material: Zirconia (ZrO2 ≥99.0%) with inorganic pigments (Fe2O3, Er2O3 ≤1%). Form factors: Semic, rod, block, disc. Sintering temperature: 1500±50°C. Crystal morphology: Tetragonal. Standards: ISO 6872 (Type II Class 6), ISO 10993. Non-sterile.

Indications for Use

Indicated for patients requiring dental restorations, including artificial teeth in fixed or removable dentures, jacket crowns, facings, 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

• Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (K141724)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 27, 2016

Nissin-metec China Co., Ltd. % Diana Hong General Manager Mid-link Consulting Co., Ltd P.O. Box 120-119 Shaghai, 200120 CN

Re: K160367

Trade/Device Name: Nissin Dental Zirconia Blank & Dental Zirconia Pre-shaded Blank Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH and ELL Dated: February 4, 2016 Received: February 9, 2016

Dear Diana Hong:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Tina Kiang 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)

Device Name

Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Indications for Use (Describe)

Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank 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) | |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <span style="font-size: 1em;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 1em;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: __________________________________________________________________________________________________________________________________________________

- 1. Date of Preparation: 06/23/2016
- 2. Sponsor Identification

## Nissin-Metec China Co., Ltd. No.883 Beimen Road, Yushan Town, Kunshan City, Jiangsu Province, 215316, China

Establishment Registration Number: Not yet registered for the Number

Contact Person: Shen Xiwei Position: General Manager Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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#### 4. Identification of Proposed Device

Trade Name: Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Common Name: Zirconia Blocks

### Regulatory Information

Classification Name: Porcelain Powder for Clinical Use Classification: 2 Product Code: EIH Regulation Number: 872.6660 Review Panel: Dental

Intended Use Statement:

Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

### Device Description

Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blanks are available in various specifications, which are combinations of different dimensions and shapes (Semics, Rods, Blocks and Discs). Furthermore, each specification is available in twenty two (22) color configurations.

#### 5. Identification of Predicate Device(s)

510(k) Number: K141724 Product Name: Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Manufacturer: Liaoning Upcera Co., Ltd

#### 6. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device, including

- > Performance Test per ISO 6872: 2008, Dentistry - Ceramic materials
- Density Test A
- A Cytotoxicity per ISO 10993-5:2009;
- Intracutaneous Reactivity Test per ISO 10993-10:2010; >
- > Sensitization Test per ISO 10993-10:2010
- > Acute Systematic Toxicity per ISO 10993-11:2006;
- Genotoxicity Tests per ISO 10993-3:2003. A

The results of the non-clinical tests are listed as following:

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| Item | Testing result |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Radioactivity | $<5.0\times10^{-3}\text{Bq} \cdot \text{g}^{-1}$<br>Conforms to ISO 6872 |
| Flexural strength | $\geq$ 800MPa<br>Conforms to ISO 6872 |
| Linear thermal<br>expansion coefficient | $(10.5\pm0.5)\times10^{-6}\text{K}^{-1}$<br>Conforms to ISO 6872 |
| Chemical solubility | $<100\mu\text{g}\cdot\text{cm}^{-2}$<br>Conforms to ISO 6872 |
| Density | 6g/cm3 |
| Cytotoxicity | The test article showed none Cytotoxicity. |
| Intracutaneous<br>Reactivity Test | The mean score difference between the test sample (the<br>extracts from 0.9% sodium chloride solution and cotton oil)<br>and the corresponding vehicle blank is 0.00 and 0.42,<br>respectively. |
| Sensitization Test | The test material showed no device of causing sensitization. |
| Systematic Toxicity | The test article showed no systematic toxicity and met the<br>requirement of ISO 10993-11: 2006 standard. |
| Mouse Lymphoma<br>Mutagenesis Assay | The results indicated that the extracts of test article did not<br>cause a positive response in the non-activated and<br>S9-activated systems and were concluded to be negative. |
| AMES | The test article is considered non-mutagenic in this assay. |

Table 1 Results of Non-clinical Tests

#### 7. Clinical Test Conclusion

No clinical study is included in this submission.

- Substantially Equivalent (SE) Comparison 8.

| ITEM | Subject Device | Predicate Device |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Nissin Dental Zirconia Blank &<br>Dental Zirconia Pre-Shaded Blank | K141724 |
| Product Code | EIH | EIH |
| Regulation<br>Number | 872.6660 | 872.6660 |
| Intended Use | Nissin Dental Zirconia Blank &<br>Dental Zirconia Pre-Shaded Blank are<br>indicated for the production of<br>artificial teeth in fixed or removable<br>dentures, or for jacket crowns, | Upcera Dental Zirconia Blank &<br>Dental Zirconia Pre-Shaded Blank<br>are used for dental restorations using<br>different CAD/CAM or manual<br>milling machines. All blanks are |

Table 2 Comparison of Technology Characteristics

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| | facings, and veneers. | processed<br>thought<br>dental<br>laboratories or by dental<br>professionals. |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Feature | Uncolored and Colored | Uncolored and Colored |
| Shape | Semic, Rods, Blocks and Dics | Rods, Blocks and Dics |
| Type and Class<br>per ISO 6872 | Type II Class 6 | Type II Class 6 |
| Sterility | Non-sterile | Non-Sterile |
| Chemical<br>Composition<br>(Weight %) | ZrO2≥99.0%<br><br>Inorganic Pigment<br>(Fe2O3, Er2O3) ≤ 1% | ZrO2≥99.0%<br><br>Inorganic Pigment<br>(Fe2O3, Er2O3 Pr2O3) ≤ 2% |
| Crystal<br>Morphology | Tetragonal | Tetragonal |
| Density | 6.00g/cm³ | 6.00g/cm³ |
| Sintering<br>temperature | 1500±50°C | >1500°C |
| Radioactivity | <5.0×10-3Bq • g-1 | <1.0 Bq · g-1 |
| Flexural<br>strength | ≥800MPa | ≥800MPa |
| Linear thermal<br>expansion<br>coefficient | (10.5±0.5)×10-6K-1 | (10.5±0.5)×10-6K-1 |
| Performance | Comply with ISO 6872 | Comply with ISO 6872 |
| Contact Level | surface device with permanent contact<br>(>30 days) | surface device with permanent<br>contact (>30 days) |
| Biocompatibility | Tested for Cytotoxicity, irritation,<br>sensitization, genotoxicity, no adverse<br>react identified | Tested for Cytotoxicity, irritation,<br>sensitization, genotoxicity, no<br>adverse react identified |

Substantially Equivalent (SE) Conclusion

Subject device, Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, is very similar to the predicate device, except for the different wording for intended use and an additional shape (Semic). For different wording for intended use, they share same intended use actually. Both of the proposed device and predicate device are intended for production of artificial teeth using CAD/CAM or manual milling machines. For the additional shape (Semic), the device has same compositions for each shape. The performance of this product is mainly affected by the compositions instead of its shape. Therefore, these differences will not effect equivalence.

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.