Pürzir Dental Zirconia blanks are used for dental restorations using different CAD / CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.

Device Description

Pürzir Dental Zirconia are disc shaped zirconia oxide blanks made available in different versions and chemical compositions of various colors, shades and dimensions and sold to dental labs that will further process the discs by milling them to make final dental restorations such as crowns, bridges, veneers, inlays and on lays based on the anatomical rendering of the patient's teeth using Computer Aided Drafting / Computer Aided Machining (CAD / CAM) equipment. The subject device is made available in six versions: 1. HS (High Strength), 2. HT (High Translucent), 3. HT Plus (High Translucent Plus), 4. ST (Super Translucent), 5. MMT x2 (Max Multi Translucent), and 6. MMT Plus x2 (Max Multi Translucent Plus).

AI/ML Overview

The provided text is a 510(k) summary for the Pürzir Dental Zirconia device. It describes the device, compares it to a predicate device, and outlines the non-clinical performance testing conducted to demonstrate substantial equivalence. However, it does not contain the specific information required to complete the requested table and details about a study proving the device meets acceptance criteria related to AI or human reader performance.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of acceptance criteria and the reported device performance

The document mentions several performance tests were conducted in accordance with ISO 6872, but it does not explicitly state the acceptance criteria for each test or the reported performance values. It only broadly states "Results confirm that the design inputs and performance specifications for the subject device have been met."

To provide a complete table, I would require the specific acceptance limits for each test (e.g., minimum flexural strength, maximum chemical solubility) and the actual measured results for the Pürzir Dental Zirconia.

Example of how the table would look if the information were present:

Performance Test (ISO 6872)	Acceptance Criteria	Reported Device Performance
Chemical solubility	[e.g., < 100 µg/cm²]	[e.g., 50 µg/cm²]
Flexural strength	[e.g., > 1000 MPa]	[e.g., 1200 MPa]
Coefficient of linear thermal expansion	[e.g., 9-11 x 10⁻⁶ K⁻¹]	[e.g., 9.8 x 10⁻⁶ K⁻¹]

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states that "final finished samples of their device" were tested for non-clinical performance. However, it does not specify the sample size for these tests. It also does not provide any information about data provenance as these are laboratory performance tests of materials, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not present in the document. The testing described is non-clinical material performance testing (e.g., flexural strength, chemical solubility), which does not involve human experts establishing ground truth in the way a diagnostic AI study would.

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

This information is not applicable and not present in the document, as it pertains to human interpretation/assessment, not material property 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

The document explicitly states: "Clinical testing on the subject device have not been performed." Therefore, no MRMC study was done, and no information about AI assistance or its effect on human readers is provided. This device is a dental material, not an AI-powered diagnostic tool.

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

This information is not applicable and not present in the document. The device is a physical dental material (zirconia blanks), not an algorithm or AI system.

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

For the non-clinical performance testing (ISO 6872 standards), the "ground truth" is defined by the objective measurement results according to the specified test methodologies outlined in the standards (e.g., using a universal testing machine for flexural strength, gravimetric analysis for chemical solubility). This is a laboratory measurement-based ground truth, not expert consensus, pathology, or outcomes data, as those are typically relevant for clinical or diagnostic studies.

8. The sample size for the training set

This information is not applicable and not present in the document. Since this is a physical dental material and not an AI/machine learning device, there is no "training set."

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

This information is not applicable and not present in the document, as there is no training set.

In summary, the provided FDA 510(k) summary is for a traditional medical device (dental zirconia blanks) and focuses on demonstrating substantial equivalence through non-clinical material performance testing and biocompatibility. The questions posed are largely geared towards the evaluation of AI-powered diagnostic devices, which is not the nature of the Pürzir Dental Zirconia.

Summary

{0}------------------------------------------------

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 & Human Services logo. To the right of that is the FDA logo, which 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.

May 13, 2020

3DBioCAD % Stuart Goldman Sr. Consultant RA/QA EMERGO Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, Texas 78746

Re: K193055

Trade/Device Name: Purzir Dental Zirconia Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: February 7, 2020 Received: February 13, 2020

Dear Stuart Goldman:

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

{1}------------------------------------------------

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 "Nandu" Nandkumar, Ph.D. 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K193055

Device Name Pürzir Dental Zirconia

Indications for Use (Describe)

Pürzir Dental Zirconia blanks are used for dental restorations using different CAD / CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.

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)

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

Pürzir Dental Zirconia

1. Submission Sponsor

3DBioCAD 1525 N 4th St. Renton, WA 98057 USA Contact: Gyu D. Cho Title: President

2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Email: LST.AUS.ProjectManagement@ul.com Contact: Stuart R. Goldman Title: Sr. Consultant RA/QA

3. Date Prepared

May 11, 2020

4. Device Identification

Trade/Proprietary Name:	Pürzir Dental Zirconia
Common/Usual Name:	Powder, Porcelain
Classification Name:	Porcelain powder for clinical use
Regulation Number:	CFR 872.6660
Product Code:	EIH
Class:	II
Classification Panel:	Dental

5. Legally Marketed Predicate Device

Device name:	Upcera Dental Zirconia Blank and Dental Zirconia Pre-Shaded Blank
510(k) number:	K141724
Manufacturer:	Liaoning Upcera Co., Ltd.

{4}------------------------------------------------

6. Indication for Use

Pürzir Dental Zirconia blanks are used for dental restorations using different CAD / CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.

7. Device Description

8. Substantial Equivalence Comparison

Table 5-1 compares Pürzir Dental Zirconia discs to the predicate device (K141724) with respect to regulatory information, intended use, indications for use, technological characteristics, and non-clinical performance testing and provides detailed information regarding the basis for the determination of substantial equivalence between the subject and predicate device.

Attributes	Subject Device	Predicate Device	Similarities / Differences
Device Name	Pürzir Dental Zirconia	Upcera Dental Zirconia Blank andDental Zirconia Pre-Shaded Blank	-
Manufacturer	3DBioCAD	Liaoning Upcera	-
510(k) #	K193055	K141724	-
Product Code	EIH	EIH	Same
Regulation	CFR 872.6660	CFR 872.6660	Same
Regulation Name	powder, porcelain	powder, porcelain	Same
Class	II	II	Same
Review Panel	Dental	Dental	Same
Indications for Use	Pürzir Dental Zirconia blanks areused for dental restorations usingdifferent CAD / CAM or manualmilling machines. All blanks areprocessed through dentallaboratories or by dentalprofessionals.	Upcera Dental Zirconia Blank andDental Zirconia Pre-Shaded Blank areused for dental restorations usingdifferent CAD / CAM or manualmilling machines. All blanks areprocessed through dentallaboratories or by dentalprofessionals.	Same
Form	Disc form.	Block, disc and rod form.	The subjectdevice is only

Table 5-1 – Substantial Equivalence Comparison of Pürzir Dental Zirconia vs. Predicate Device (K141724)

{5}------------------------------------------------

Attributes	Subject Device	Predicate Device	Similarities / Differences
			made available in disc form.
Dimensions	Various	Various	Similar
Material	Regular:Zirconia (ZrO2 + Y2O3 + HfO2 + Al2O3 ≥ 99.0%)Pre-Shaded:Zirconia (ZrO2 + Y2O3 + HfO2 + Al2O3 ≥ 98.0%)Inorganic pigments (Fe2O3, Pr2O3, and Er2O3 < 2.0%)	Regular:Zirconia (ZrO2 + Y2O3 + HfO2 + Al2O3 ≥ 99.0%)Pre-Shaded:Zirconia (ZrO2 + Y2O3 + HfO2 + Al2O3 ≥ 98.0%)Inorganic pigments (Fe2O3, Pr2O3, and Er2O3 < 2.0%)	Same
Color	None, and Pre-shaded (for pre-shaded series).	None, and Pre-shaded (for pre-shaded series).	Same
Processing	Sintering at temperature > 1500 °C	Sintering at temperature > 1500 °C	Same
Conditions of Use	Professional use for the fabrication of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers.	Professional use for the fabrication of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers.	Same
Single Use	Yes	Yes	Same
Supplied Sterile	No	No	Same
Packaging	Single blank (disc) per box.	Single blank (disc) per box.	Same
Shelf Life	5 years from date of manufacture	5 years from date of manufacture	Same
Biocompatibility Testing	Tested to ISO 10993-1	Tested to ISO 10993-1	Conforms
Performance Testing	Tested to ISO 6872	Tested to ISO 6872	Conforms

9. Summary of Non-Clinical Performance Testing

As part of demonstrating substantial equivalence of Pürzir Dental Zirconia discs to the predicate device, 3DBioCAD tested final finished samples of their device in accordance with the applicable parts of the following FDA guidance documents and voluntary recognized consensus standards. Results confirm that the design inputs and performance specifications for the subject device have been met.

. Biocompatibility Testing:
- o FDA Guidance Document Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process

{6}------------------------------------------------

ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and testing within o a risk management process:
- " ISO 10993-3 (genotoxicity)
- 트 ISO 10993-5 (cytotoxicity)
- " ISO 10993-10 (skin sensitization and irritation)
- I ISO 10993-11 (toxicity)
Non-Clinical Performance Testing:
- o ISO 6872, Dentistry Ceramic materials
  - I chemical solubility
  - 트 flexural strength
  - coefficient of linear thermal expansion

10. Clinical Testing

Clinical testing on the subject device have not been performed.

11. Statement of Substantial Equivalence

Pürzir Dental Zirconia has the same intended use and indications for use as Upcera Dental Zirconia Blank and Dental Zirconia Pre-Shaded Blank (K141724). Any minor differences in the technological features of the subject device when compared to the predicate device have been successfully evaluated through nonclinical performance testing and other verification activities such that the information submitted to the FDA demonstrates that Pürzir Dental Zirconia is substantially equivalent 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.