(169 days)
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.
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.
This document describes the premarket notification (510(k)) for the "Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank." The submission aims to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are established primarily through conformity to ISO 6872:2008 (Dentistry - Ceramic materials) and ISO 10993 series for biocompatibility. The reported device performance is presented in "Table 1 Results of Non-clinical Tests" and compared against the predicate device in "Table 2 Comparison of Technology Characteristics."
| Item | Acceptance Criteria (typically based on ISO 6872 or ISO 10993 standards) | Reported Device Performance (Nissin Dental Zirconia Blank) |
|---|---|---|
| Radioactivity | Conforms to ISO 6872 (Predicate: <1.0 Bq · g-1) | <5.0 x 10^-3 Bq · g-1 |
| Flexural strength | ≥ 800MPa (Conforms to ISO 6872) | ≥ 800MPa |
| Linear thermal expansion coefficient | (10.5 ± 0.5) x 10^-6 K^-1 (Conforms to ISO 6872) | (10.5 ± 0.5) x 10^-6 K^-1 |
| Chemical solubility | <100 µg · cm^-2 (Conforms to ISO 6872) | <100 µg · cm^-2 |
| Density | 6g/cm3 (Predicate: 6.00g/cm³) | 6g/cm3 |
| Cytotoxicity | No Cytotoxicity (Conforms to ISO 10993-5:2009) | The test article showed none Cytotoxicity. |
| Intracutaneous Reactivity Test | Low reactivity, typically mean score difference < 1.0 (Conforms to ISO 10993-10:2010) | Mean score difference between test sample and vehicle blank is 0.00 and 0.42. |
| Sensitization Test | No sensitization (Conforms to ISO 10993-10:2010) | The test material showed no device of causing sensitization. |
| Systematic Toxicity | No systematic toxicity (Conforms to ISO 10993-11:2006) | The test article showed no systematic toxicity and met the requirement of ISO 10993-11: 2006 standard. |
| Mouse Lymphoma Mutagenesis Assay | Negative for mutagenesis (Conforms to ISO 10993-3:2003) | The results indicated that the extracts of test article did not cause a positive response... and were concluded to be negative. |
| AMES | Non-mutagenic (Conforms to ISO 10993-3:2003) | The test article is considered non-mutagenic in this assay. |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific non-clinical test (e.g., number of samples for flexural strength, number of animals for biocompatibility tests). The tests are described as non-clinical and conducted to verify design specifications. The provenance of the data is from the manufacturer's testing, likely in China, as the sponsor is Nissin-Metec China Co., Ltd. These are retrospective tests conducted on the device prior to submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. For non-clinical material testing and biocompatibility assessments, "ground truth" is typically established by laboratory standards and validated testing protocols (e.g., ISO standards), rather than expert consensus on individual cases. The tests are designed to measure intrinsic material properties and biological reactivity.
4. Adjudication Method for the Test Set
Adjudication methods for test sets are relevant for studies involving human interpretation or subjective assessments. For the non-clinical material and biocompatibility tests described, such methods are not applicable and not mentioned. The results are objective measurements or categorical outcomes (e.g., "no cytotoxicity").
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
No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for AI/CADe (Computer-Aided Detection) or CADx (Computer-Aided Diagnosis) systems where human readers interact with AI. The device in question is a dental zirconia blank, a material used for restorations, not an AI system that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone performance study in the context of an AI algorithm was not done. This device is a material, not an algorithm. The performance tests are for the physical and biological properties of the material itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests is established by objective measurements against recognized international standards (e.g., ISO 6872 for material properties) and validated laboratory protocols for biocompatibility testing (e.g., ISO 10993 series). For instance, flexural strength has a specific numerical value, and cytotoxicity is determined by cell viability assays compared to controls. This is not based on expert consensus, pathology, or outcomes data in the way it would be for a diagnostic device.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a physical material, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided for the same reason as point 8.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ 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: __________________________________________________________________________________________________________________________________________________
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- Date of Preparation: 06/23/2016
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- 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: 86 512 36857051 Fax: 86 512 36857050 Email: xw-shen@nissin-metec.com
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- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
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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
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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; >
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Sensitization Test per ISO 10993-10:2010
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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 | $<5.0\times10^{-3}\text{Bq} \cdot \text{g}^{-1}$Conforms to ISO 6872 |
| Flexural strength | $\geq$ 800MPaConforms to ISO 6872 |
| Linear thermalexpansion coefficient | $(10.5\pm0.5)\times10^{-6}\text{K}^{-1}$Conforms to ISO 6872 |
| Chemical solubility | $<100\mu\text{g}\cdot\text{cm}^{-2}$Conforms to ISO 6872 |
| Density | 6g/cm3 |
| Cytotoxicity | The test article showed none Cytotoxicity. |
| IntracutaneousReactivity Test | The mean score difference between the test sample (theextracts from 0.9% sodium chloride solution and cotton oil)and the corresponding vehicle blank is 0.00 and 0.42,respectively. |
| Sensitization Test | The test material showed no device of causing sensitization. |
| Systematic Toxicity | The test article showed no systematic toxicity and met therequirement of ISO 10993-11: 2006 standard. |
| Mouse LymphomaMutagenesis Assay | The results indicated that the extracts of test article did notcause a positive response in the non-activated andS9-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 &Dental Zirconia Pre-Shaded Blank | K141724 | |
| Product Code | EIH | EIH |
| RegulationNumber | 872.6660 | 872.6660 |
| Intended Use | Nissin Dental Zirconia Blank &Dental Zirconia Pre-Shaded Blank areindicated for the production ofartificial teeth in fixed or removabledentures, or for jacket crowns, | Upcera Dental Zirconia Blank &Dental Zirconia Pre-Shaded Blankare used for dental restorations usingdifferent CAD/CAM or manualmilling machines. All blanks are |
Table 2 Comparison of Technology Characteristics
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| facings, and veneers. | processedthoughtdentallaboratories or by dentalprofessionals. | |
|---|---|---|
| Feature | Uncolored and Colored | Uncolored and Colored |
| Shape | Semic, Rods, Blocks and Dics | Rods, Blocks and Dics |
| Type and Classper ISO 6872 | Type II Class 6 | Type II Class 6 |
| Sterility | Non-sterile | Non-Sterile |
| ChemicalComposition(Weight %) | ZrO2≥99.0%Inorganic Pigment(Fe2O3, Er2O3) ≤ 1% | ZrO2≥99.0%Inorganic Pigment(Fe2O3, Er2O3 Pr2O3) ≤ 2% |
| CrystalMorphology | Tetragonal | Tetragonal |
| Density | 6.00g/cm³ | 6.00g/cm³ |
| Sinteringtemperature | 1500±50°C | >1500°C |
| Radioactivity | <5.0×10-3Bq • g-1 | <1.0 Bq · g-1 |
| Flexuralstrength | ≥800MPa | ≥800MPa |
| Linear thermalexpansioncoefficient | (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(>30 days) | surface device with permanentcontact (>30 days) |
| Biocompatibility | Tested for Cytotoxicity, irritation,sensitization, genotoxicity, no adversereact identified | Tested for Cytotoxicity, irritation,sensitization, genotoxicity, noadverse 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.
§ 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.