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 (10~~25mm), color model (0M1/A1~~A4/B1~~B4/C1~~C4/D2~D4) and transparency model (T41/T45/T49/TR).

AI/ML Overview

This document is a 510(k) Premarket Notification for a dental material, not a medical device involving AI or software. Therefore, the requested information about acceptance criteria, study details, and AI-specific metrics (like human reader improvement with AI assistance) is not applicable to this submission.

Here's a breakdown of why many of your questions cannot be answered from the provided text:

No AI or Software: The device, "Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank," is a material for dental restorations. It does not involve any artificial intelligence, machine learning, or software components that would have performance metrics like sensitivity, specificity, or AUC, or require a ground truth established by experts.
No Diagnostic or Interpretive Task: This device is a component used in manufacturing, not a diagnostic tool that interprets data or images.
No Clinical Study for Performance Evaluation: The document explicitly states: "No clinical study is included in this submission." This means there is no human-in-the-loop performance evaluation or comparison against human experts.

However, I can extract information related to the performance testing that was conducted for this material:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here refer to the performance standards and biocompatibility tests for the material itself, not diagnostic accuracy. The reported device performance indicates conformance to these standards.

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria (Predicate)	Reported Device Performance (Subject Device)
Material Properties
Type and Class per	Type II Class 5	Type II Class 5
ISO 6872:2015
Chemical Composition	ZrO2 ≥ 99.0%, Inorganic Pigment (Fe2O3, Er2O3) ≤ 1%	ZrO2 > 99.0%, Inorganic Pigment (Al2O3, SiO2, Fe2O3, Er2O3) < 1%
Crystal Morphology	Tetragonal	Tetragonal
Density	6.00 g/cm³	6.00 g/cm³
Sintering temperature	1500 ± 50°C	1500 ± 50°C
Performance	Comply with ISO 6872	Comply with ISO 6872
Biocompatibility
Cytotoxicity	No adverse reaction identified (Tested)	No adverse react identified (Tested per ISO 10993-5:2009)
Intracutaneous Reactivity	No adverse reaction identified (Tested)	No adverse react identified (Tested per ISO 10993-10:2010)
Sensitization	No adverse reaction identified (Tested)	No adverse react identified (Tested per ISO 10993-10:2010)
Acute Systemic Toxicity	No adverse reaction identified (Tested)	No adverse react identified (Tested per ISO 10993-11:2006)
Genotoxicity	No adverse reaction identified (Tested)	No adverse react identified (Tested per ISO 10993-3:2014)

2. Sample size used for the test set and the data provenance:

This information is not provided in a way that relates to "test sets" for diagnostic performance. For the material properties and biocompatibility tests, the sample sizes and specific types of samples (e.g., number of discs tested for density) are not detailed in this summary. The data provenance is internal testing conducted by the manufacturer to demonstrate compliance with international standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There is no "ground truth" to be established by experts in the context of diagnostic accuracy for this material. The tests are chemical, physical, and biological assessments of the material itself.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No diagnostic adjudication method is relevant to material property and biocompatibility testing.

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:

Not applicable. This is not an AI device, and no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable in the diagnostic sense. For material properties, the "ground truth" is established by verifiable scientific measurement against established international standards (e.g., ISO 6872 for ceramic materials, ISO 10993 for biocompatibility).

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

In summary, the provided document is a 510(k) summary for a dental material, not an AI or software-based medical device. Therefore, most of the questions relating to AI performance metrics, expert adjudication, and ground truth establishment for diagnostic purposes are irrelevant to this specific submission. The "acceptance criteria" and "performance" discussed are related to the material's physical, chemical, and biological properties.

Summary

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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);

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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

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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: ____

1. Date of Preparation: 02/24/2018
1. 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

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.
Density Test
Cytotoxicity per ISO 10993-5:2009;
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;
Genotoxicity Tests per ISO 10993-3:2014.
1. 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-ShadedBlank	K160367
Product Code	EIH	EIH
RegulationNumber	872.6660	872.6660
Intended Use	Crown Dental Zirconia Blank &Crown Dental Zirconia Pre-ShadedBlank are indicated for the productionof artificial teeth in fixed orremovable dentures, or for jacketcrowns, facings, and veneers.	Nissin Dental Zirconia Blank &Dental Zirconia Pre-Shaded Blankare indicated for the production ofartificial teeth in fixed or removabledentures, or for jacket crowns,facings, and veneers
Feature	Colored	Uncolored and Colored
Shape	Discs	Semic, Rods, Blocks and Discs
Type and Classper 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) < 1%	Inorganic Pigment(Fe2O3, Er2O3) ≤ 1%
CrystalMorphology	Tetragonal	Tetragonal
Density	6.00g/cm³	6.00g/cm³
Sinteringtemperature	1500±50°C	1500±50°C
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, 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.

Regulation Number and Section

§ 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.