(84 days)
Not Found
No
The device description and performance studies focus on the material properties and physical characteristics of zirconia blanks for dental prosthetics, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is a blank used to produce artificial teeth (prosthetics), which are considered restorative rather than therapeutic. Therapeutic devices are typically used to treat or cure a disease or condition.
No
The device is described as a blank for producing artificial teeth, not for diagnosing medical conditions. Its intended use is for fabricating dental prosthetics.
No
The device description clearly states it is a physical blank made of zirconia, available in disc shape with various specifications related to height, color, and transparency. This indicates a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the device is a "Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank" intended for the "production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers." This is a material used to create dental prosthetics, not a test performed on a biological sample.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes.
Therefore, based on the provided information, this device falls under the category of a dental material used for restorative purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Crown Dental Zirconia Blank & Crown 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
Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank are available in discs shape, and in various specifications, which are combinations of height (1025mm), color model (0M1/A1A4/B1B4/C1C4/D2~D4) and transparency model (T41/T45/T49/TR).
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
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 Fourth Edition 2015-06-01, Dentistry - Ceramic Materials.
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Density Test
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Cytotoxicity per ISO 10993-5:2009;
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Intracutaneous Reactivity Test per ISO 10993-10:2010;
- A Sensitization Test per ISO 10993-10:2010
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Acute Systematic Toxicity per ISO 10993-11:2006;
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Genotoxicity Tests per ISO 10993-3:2014.
No clinical study is included in this submission.
Key Metrics
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/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of it is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font, and "ADMINISTRATION" in a smaller font below.
Crown Porcelain Dental Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd. P.O. Box 120-119 Shanghai, 200120 Cn
April 24, 2018
Re: K180252
Trade/Device Name: Crown Dental Zirconia Blank & Crown 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 Dated: February 27, 2018 Received: March 7, 2018
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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 -S
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
2
Indications for Use
510(k) Number (if known) K180252
Device Name
Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank
Indications for Use (Describe)
Crown Dental Zirconia Blank & Crown 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Tab #7 510(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: 02/24/2018
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- Sponsor Identification
Crown Porcelain Dental Technology Co., Ltd. 5F.-1, No.189, Sec.2, Keelung Rd., Xinyi Dist.,
Taipei City 110, Taiwan
Establishment Registration Number: Not yet registered for the Number
Contact Person: Chu Lien Fan Position: General Manager Tel: +886-2-2732-4911 ext.11 Fax: +886-2-2732-9209 Email: tpe0709@gmail.com
3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Betty Xiao (Alternative Contact Person)
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
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4. Identification of Proposed Device
Trade Name: Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank Common Name: Zirconia Blocks
Regulatory Information
Classification Name: Powder, Porcelain Classification: 2 Product Code: EIH Regulation Number: 872.6660 Review Panel: Dental
Intended Use Statement:
Crown Dental Zirconia Blank & Crown 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
Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank are available in discs shape, and in various specifications, which are combinations of height (1025mm), color model (0M1/A1A4/B1B4/C1C4/D2~D4) and transparency model (T41/T45/T49/TR).
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ર. Identification of Predicate Device(s)
510(k) Number: K160367 Product Name: Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Manufacturer: Nissin-Metec China Co., Ltd. -
Non-Clinical Test Conclusion 6.
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 Fourth Edition 2015-06-01, Dentistry - Ceramic Materials.
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Density Test
-
Cytotoxicity per ISO 10993-5:2009;
-
Intracutaneous Reactivity Test per ISO 10993-10:2010;
-
A Sensitization Test per ISO 10993-10:2010
5
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Acute Systematic Toxicity per ISO 10993-11:2006;
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Genotoxicity Tests per ISO 10993-3:2014.
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- Clinical Test Conclusion
No clinical study is included in this submission.
- Substantially Equivalent (SE) Comparison 8.
| ITEM | Subject Device | Predicate Device |
|---|---|---|
| Crown Dental Zirconia Blank & | ||
| Crown Dental Zirconia Pre-Shaded | ||
| Blank | K160367 | |
| Product Code | EIH | EIH |
| Regulation | ||
| Number | 872.6660 | 872.6660 |
| Intended Use | Crown Dental Zirconia Blank & | |
| Crown 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 Blank | ||
| are indicated for the production of | ||
| artificial teeth in fixed or removable | ||
| dentures, or for jacket crowns, | ||
| facings, and veneers | ||
| Feature | Colored | Uncolored and Colored |
| Shape | Discs | Semic, Rods, Blocks and Discs |
| Type and Class | ||
| per ISO 6872: | ||
| 2015 | Type II Class 5 | Type II Class 5 |
| Sterility | Non-sterile | Non-Sterile |
| Chemical | ZrO2>99.0% | ZrO2≥99.0% |
| Composition | ||
| (Weight %) | Inorganic Pigment | |
| (Al2O3, SiO2, Fe2O3, Er2O3) 30 days) | surface device with permanent | |
| contact (>30 days) | ||
| Biocompatibility | ||
| Tested for Cytotoxicity, irritation, sensitization, accurate systematic toxicity, genotoxicity, no adverse react identified. | Tested for Cytotoxicity, irritation, sensitization, accurate systematic toxicity, genotoxicity, no adverse react identified. |
Table 1 Comparison of Technology Characteristics
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Subject device, Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank, is very similar to the predicate device, except for an additional Inorganic Pigment, the difference will not result in any new safety and effectiveness issue.
Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.