ZMAXX Dental Zirconia Blanks are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

Device Description

Dental Zirconia Blank is available in various specifications, which are combinations of height (12~~25mm), color model (0M1/A1~~ A3/B1~~B4/C1~~C4/D2~D4) and transparency model (T45).

AI/ML Overview

This document describes the 510(k) premarket notification for ZMAXX Dental Zirconia Blanks (K191631). It does not pertain to an AI/ML powered medical device, therefore many of the requested categories (such as experts, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable.

Here's the information directly related to the acceptance criteria and study as presented:

Acceptance Criteria and Device Performance for ZMAXX Dental Zirconia Blanks (K191631)

This submission is for a medical device (ZMAXX Dental Zirconia Blanks) which is a physical material used for dental restorations, not an AI/ML software device. Therefore, the "acceptance criteria" and "device performance" are primarily based on meeting established industry standards for dental ceramic materials and demonstrating bio-compatibility, rather than performance metrics typically associated with AI/ML systems (e.g., accuracy, sensitivity, specificity).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by compliance with relevant ISO standards and a comparison to a predicate device.

Characteristic / Test	Acceptance Criteria (Implicit from Standards/Predicate)	Reported Device Performance (ZMAXX Dental Zirconia Blanks)
Performance Test (per ISO 6872:2015)	Comply with ISO 6872:2015, Dentistry-Ceramic materials (e.g., strength requirements for Type II Class 5)	Comply with ISO 6872 (specifically, it is Type II Class 5)
Density Test	Comparable to predicate device (6.00 g/cm³)	6.00 g/cm³
Cytotoxicity (per ISO 7405:2008)	No adverse reaction identified	Tested; no adverse react identified
Intracutaneous Reactivity (per ISO 10993-10:2010)	No adverse reaction identified	Tested; no adverse react identified
Sensitization (per ISO 10993-10:2010)	No adverse reaction identified	Tested; no adverse react identified
Acute Systematic Toxicity (per ISO 10993-11:2006)	No adverse reaction identified	Tested; no adverse react identified
Genotoxicity (per ISO 10993-3:2014)	No adverse reaction identified	Tested; no adverse react identified
Chemical Composition (Weight %)	ZrO₂ >99.0%, Inorganic Pigment (Al₂O₃, SiO₂, Fe₂O₃, Er₂O₃) < 1%	ZrO₂ >99.0%, Inorganic Pigment (Al₂O₃, SiO₂, Fe₂O₃, Er₂O₃) < 1% (predicate: Fe₂O₃, Er₂O₃ ≤ 1%)
Crystal Morphology	Tetragonal (matching predicate)	Tetragonal
Sintering Temperature	1500 ± 50°C (matching predicate)	1500 ± 50°C

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each test mentioned (e.g., how many samples were tested for density, or how many biological samples for cytotoxicity). The tests conducted are non-clinical, primarily material and biological safety tests performed in a laboratory setting. The data provenance is implied to be from the manufacturer's internal testing or third-party laboratory testing, with no mention of country of origin for the specific test data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

N/A. This is a material science and biocompatibility assessment, not an AI/ML diagnostic or prognostic system requiring expert ground truth for image interpretation or similar tasks. Compliance with ISO standards and lab test results serve as the "ground truth."

4. Adjudication Method for the Test Set

N/A. Not applicable for material and biocompatibility testing. The "adjudication" is essentially the determination of compliance with the specified test methodology and acceptance criteria of the relevant ISO standards.

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

N/A. This is not an AI/ML device.

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

N/A. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for the performance and safety of the ZMAXX Dental Zirconia Blanks is based on:

Compliance with International Standards: Specifically, ISO 6872:2015 for ceramic materials and various ISO 10993 series standards for biocompatibility (Cytotoxicity, Intracutaneous Reactivity, Sensitization, Acute Systematic Toxicity, Genotoxicity).
Predicate Device Comparison: The characteristics and performance (e.g., density, chemical composition, crystal morphology, sintering temperature) are compared to a legally marketed predicate device (Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, K160367).

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

N/A. This is not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 1, 2019

ZMAXX Bioceramics LLC % Ying Xu General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA

Re: K191631

Trade/Device Name: ZMAXX Dental Zirconia Blanks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: Class II Product Code: EIH Dated: August 9, 2019 Received: August 23, 2019

Dear Ying Xu:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K191631

Device Name ZMAXX Dental Zirconia Blanks

Indications for Use (Describe)

ZMAXX Dental Zirconia Blanks 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)
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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: _K191631

1. Date of Preparation: 05/10/2019
Sponsor Identification 2.

ZMAXX BIOCERAMICS LLC

231 PELICAN CT FOSTER CITY, CA 94404

Establishment Registration Number: Not yet registered for the Number

Contact Person: Josef Wu Position: General Manager Tel: +1-510-774-1317 Email: raywheel.trading@gmail.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

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

Tel: +86-21-22815850, Fax: +1(0)360 925-3199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: ZMAXX Dental Zirconia Blanks Common Name: Zirconia Blocks

Regulatory Information

Classification Name: Powder, Porcelain Classification: II Product Code: EIH Regulation Number: 872.6660 Review Panel: Dental

Indication for Use:

ZMAXX Dental Zirconia Blanks are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

Device Description

Dental Zirconia Blank is available in various specifications, which are combinations of height (12~~25mm), color model (0M1/A1~~ A3/B1~~B4/C1~~C4/D2~D4) and transparency model (T45).

1. Identification of Predicate Device
  510(k) Number: K160367 Product Name: Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Manufacturer: Nissin-Metec China Co., Ltd
1. 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: 2015, Dentistry-Ceramic materials
Density Test
Cytotoxicity per ISO 7405:2008;
Intracutaneous Reactivity Test per ISO 10993-10:2010;
Sensitization Test per ISO 10993-10:2010
Acute Systematic Toxicity per ISO 10993-11:2006;

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♪ Genotoxicity Tests per ISO 10993-3:2014.
1. Clinical Test Conclusion

No clinical study is included in this submission.

Substantially Equivalent (SE) Comparison 8.

			Table 1 Comparison of Technology Characteristics
--	--	--	--------------------------------------------------

ITEM	Subject Device	Predicate Device K160367
Product Code	EIH	EIH
Regulation Number	872.6660	872.6660
Indication for Use	ZAMAXX Dental Zirconia Blanks 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 Dics
Type and Class per ISO 6872	Type II Class 5	Type II Class 5
Sterility	Non-Sterile	Non-sterile
Chemical Composition(Weight %)	ZrO2 >99.0%Inorganic Pigment(Al2O3, SiO2, Fe2O3, Er2O3) < 1%	ZrO2≥99.0%Inorganic Pigment(Fe2O3, Er2O3) ≤ 1%
Crystal Morphology	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 permanentcontact (>30 days)	surface device with permanentcontact (>30 days)
Biocompatibility	Tested for Cytotoxicity, irritation, sensitization, systematic toxicity, genotoxicity, no adverse react	Tested for Cytotoxicity, irritation, sensitization, systematic toxicity, genotoxicity, no adverse react identified

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		identified.
--	--	-------------	--

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.

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Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.

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.