(169 days)
Not Found
No
The summary describes a material (zirconia blanks) used for creating dental prosthetics and focuses on its physical and biological properties. There is no mention of software, algorithms, or any technology that would involve AI or ML.
No.
The device is a material used for the production of artificial teeth, primarily a restorative dental material rather than a device with a direct therapeutic effect on the body.
No
Explanation: The device is a material (zirconia blanks) used for manufacturing artificial teeth and dental prosthetics, not for identifying or diagnosing a medical condition. Its intended use is for production, not diagnosis.
No
The device description clearly states it is a physical product (zirconia blanks) used for creating dental prosthetics, and the performance studies involve physical and biological testing of the material.
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, jacket crowns, facings, and veneers. This is a structural and restorative application within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a blank material used to create dental prosthetics. It's a physical component, not a reagent or instrument used for analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on material properties (flexural strength, density, chemical solubility, etc.) and biocompatibility, which are relevant for a medical device intended for implantation or contact with the body, but not for an IVD.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for 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.
Product codes
EIH
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.
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
Not Found
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)
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
- 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.
Key results:
- Radioactivity: -3 Bq · g-1, Conforms to ISO 6872
- Flexural strength: >= 800MPa, Conforms to ISO 6872
- Linear thermal expansion coefficient: (10.5 +/- 0.5) × 10-6 K-1, Conforms to ISO 6872
- Chemical solubility: -2, Conforms to ISO 6872
- Density: 6g/cm³
- Cytotoxicity: The test article showed none Cytotoxicity.
- Intracutaneous Reactivity Test: The mean score difference between the test sample (the extracts 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 the requirement of ISO 10993-11: 2006 standard.
- Mouse Lymphoma Mutagenesis Assay: The results indicated that the extracts of test article did not cause a positive response in the non-activated and S9-activated systems and were concluded to be negative.
- AMES: The test article is considered non-mutagenic in this assay.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
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
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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: __________________________________________________________________________________________________________________________________________________
-
- Date of Preparation: 06/23/2016
-
- 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
-
- 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
4
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:
5
| Item | Testing result |
|---|---|
| Radioactivity | $1500°C |
| Radioactivity | 30 days) |
| contact (>30 days) | |
| Biocompatibility | Tested for Cytotoxicity, irritation, |
| sensitization, genotoxicity, no adverse | |
| react identified | Tested for Cytotoxicity, irritation, |
| sensitization, genotoxicity, no | |
| 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.