GenesisZr™ 4Y Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns and bridges). GenesisZr™ 4Y Zirconia blanks are intended to be milled and fully sintered before use for:

Full contour monolithic crowns and bridges in anterior and posterior regions.
Anatomically reduced for veneering, crown and bridge frames.
Bridge to be limited to 3 units with a maximum of 1 pontic.

Device Description

GenesisZr™ 4Y Zirconia are disc shaped dental porcelain zirconia oxide blanks that come in one color, white, and various sizes that are used in customized restorations by the dental laboratory. The dental laboratory will further process the blank by milling the blank based upon the anatomically rendering of the patient's teeth (done at the dental office) through "Computer Aided Drafting/ Computer Aided Machining (CAD/CAM). Once the customized rendered blank is milled the device is fully sintered and colored (if required) and fitted to the patient's teeth as dentures, crowns or bridges.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a dental device, GenesisZr™ 4Y Zirconia. This document primarily focuses on establishing substantial equivalence to a predicate device based on material properties, indications for use, and standardized bench testing.

It explicitly states that "Clinical tests have not been performed." Therefore, the document does not contain information related to acceptance criteria for clinical performance, human reader studies (MRMC), or ground truth establishment based on expert consensus, pathology, or outcomes data as would be typically found for AI/imaging devices.

The "acceptance criteria" and "device performance" in this context refer to the results of non-clinical, bench testing against established ISO standards for dental materials.

Here's the information that can be extracted from the provided text, framed within your request:

1. A table of acceptance criteria and the reported device performance

Test Parameter / Acceptance Criteria (Standard)	Reported Device Performance (GenesisZr™ 4Y Zirconia)	Predicate Device Performance (Prismatik™ CZ), if available
Material Composition % wt.
Zirconia Powder: ZrO2+HfO2+Y2O3: >99	>99	>99
Y2O3: (Predicate: 5.2)	6.9	5.2
Al2O3: ≤ 0.05	≤ 0.05	≤ 0.05
SiO2: ≤0.002	≤0.002	N/A (Other oxides: < 0.3)
Fe2O3: ≤0.002	≤0.002	N/A (Other oxides: < 0.3)
HfO2: (Predicate: < 2)	Not explicitly stated (part of ZrO2+HfO2+Y2O3)	< 2
Freedom from extraneous materials per ISO 6872:2008 Section 5.2 (active conc. of not more than 1.0 Bq g⁻¹ of Uranium²³⁸)	<0.03	N/A
Sintered Density g/cm³ per ISO 13356: 2008 Section 4.1 (Req't. of ≥ 6.0)	6.09 g/cm³	N/A
Coefficient of thermal expansion (CTE)	10.2 µm/m °C	N/A
Fracture toughness Kıc	3.5 MPa m⁰.⁵	N/A
Flexural strength per ISO 6872: 2008 (Limit >900MPa)	1100 MPa	1100MPa
Chemical solubility per ISO 6872:2008 (Limit 100 µg/cm²)	6.0 µg/cm²	N/A
Biocompatibility per ISO 10993-1: Part 1	Biocompatibility risk management analysis conducted.	N/A
Blank sizes (mm)	Disc: 95-110mm x 10-30mm	Disc sizes: 98.5 x 10-30mm

2. Sample sizes used for the test set and the data provenance
The document does not specify the sample sizes (e.g., number of test pieces, batches) used for each non-clinical test. The tests were performed on the GenesisZr™ 4Y Zirconia material itself. The data provenance is from internal testing performed by United Dental Resources Corporation. The document does not specify country of origin for the data or whether it's retrospective or prospective, as these terms are not applicable to the non-clinical material testing described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device is based on compliance of material properties with established international standards (ISO standards) and not on expert clinical interpretation of data.

4. Adjudication method for the test set
Not applicable. There was no human interpretation or adjudication involved, as it was non-clinical material testing against pre-defined physical and chemical property limits.

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 device is a dental material, not an AI-assisted diagnostic or imaging device. Clinical tests as such were explicitly not performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm. Performance was evaluated based on the physical and chemical properties of the material itself.

7. The type of ground truth used
The "ground truth" for this submission is compliance with the requirements specified in international standards such as ISO 6872:2008 ("Dentistry - Ceramic materials") and ISO 13356: 2008 ("Implants for surgery, Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)"). It also includes a biocompatibility risk management analysis per ISO 10993-1.

8. The sample size for the training set
Not applicable. This is a material, not a machine learning model. There is no concept of a "training set" for the type of testing described.

9. How the ground truth for the training set was established
Not applicable for the reason stated above.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

United Dental Resources Corporation John Von Thaden Operations Officer 70 Towncenter Drive University Park, Illinois 60484

January 25, 2019

Re: K182642

Trade/Device Name: GenesisZr™ 4Y Zirconia Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Class II Product Code: EIH Dated: October 22, 2018 Received: October 29, 2018

Dear John Von Thaden:

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 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

Digitally signed by Mary S. Mary S. Runner -S3 Runner -S3 Date: 2019.01.25

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) K182642

Device Name GenesisZr™ 4Y Zirconia

Indications for Use (Describe)

Full contour monolithic crowns and bridges in anterior and posterior regions.
Anatomically reduced for veneering, crown and bridge frames.
Bridge to be limited to 3 units with a maximum of 1 pontic.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for United Dental Resources. The logo features the word "UNITED" in white letters on a blue rectangular background. Below "UNITED" are the words "DENTAL RESOURCES" in a smaller font. The blue rectangle is placed diagonally on top of a red shape, which appears to be a parallelogram or a rectangle tilted to the side.

510(k) Summary

for

K182642

United Dental Resources Corporation

GenesisZr™ 4Y Zirconia

1. Submitter

Owner's Name:	United Dental Resources Corporation
Address:	70 Towncenter DriveUniversity Park, IL USA 60484
Phone:	1-708-746-5730
Fax number:	1-888-503-2190
Contact Person:	John Von Thaden, Operations
Date summary prepared:	January 25, 2019

2. Device Name and Classification

Proprietary/Trade Name:	GenesisZr™ 4Y Zirconia
Common/Usual Name:	Powder, Porcelain
Classification Name:	Porcelain Powder for Clinical Use
Product Code:	EIH
Regulation Number:	21 CFR 872.6660
Device Class:	Class II

3. Predicate Device

Glidewell Laboratories, Prismatik™ Clinical Zirconia (Prismatik™ CZ) (K060104)

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Image /page/4/Picture/0 description: The image shows the logo for United Dental Resources. The logo features the word "UNITED" in blue, bold letters on a blue rectangular background. Below "UNITED" are the words "DENTAL RESOURCES" in smaller, white letters. The blue rectangle is placed diagonally on top of a red shape that resembles a skewed rectangle.

4. Indications for Use

Full contour monolithic crowns and bridges in anterior and posterior regions.
Anatomically reduced for veneering, crown and bridge frames.
Bridge to be limited to 3 units with a maximum of 1 pontic.

5. Device Description and Function

6. Substantial Equivalence Discussion

	GenesisZrTM 4Y Zirconia	PrismatikTM CZGlidewell/K060104
Indications for use	GenesisZrTM 4Y Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns and bridges). GenesisZrTM 4Y Zirconia blanks are intended to be milled and fully sintered before use for:- Full contour monolithic crowns and bridges in anterior and posterior regions.- Anatomically reduced for veneering, crown and bridge frames.- Bridge to be limited to 3 units with a maximum of 1 pontic.	For use in prosthetic dentistry to create porcelain (ceramic) protheses.For use only by or on the order of a dental professional such as a DDS or DMD. Not for use by the general public or OTC.
Contra-Indications	Class 5 indications cannot be made with this device. When GenesisZrTM 4Y Zirconia blanks are milled, do not inhale dust when removing dental prosthesis from dental holder. Take appropriate safety methods such as face mask and eye protection.	There are no specific precautions, warnings or contra-indications
	GenesisZr™ 4Y Zirconia	Prismatik™ CZGlidewell/K060104
Material Composition% wt.	Zirconia Powder:ZrO2+HfO2+Y2O3: >99Y2O3: 6.9Al2O3: ≤ 0.05SiO2: ≤0.002Fe2O3: ≤0.002	Zirconia Powder:ZrO2+HfO2+Y2O3: > 99HfO2: < 2Y2O3: 5.2Al2O3: ≤ 0.05Other oxides: < 0.3
Freedom fromextraneous materials perISO 6872:2008 Section5.2 active conc. of notmore than 1.0 Bq g-1 ofUranium238	<0.03	N/A
Sintered Density g/cm3ISO 13356: 2008 Section4.1 Req't. of ≥ 6.0	6.09 g/cm³	N/A
Coefficient of thermalexpansion (CTE)	10.2 µm/m °C	N/A
Fracture toughness Kıc	3.5 MPa m0.5	N/A
Flexural strength per ISO6872: 2008, Limit>900MPa	1100 MPa	1100MPa
Chemical solubility perISO 6872:2008 Limit 100ug/cm²	6.0 µg/cm²	N/A
Biocompatibility per ISO10993-1: Part 1 -'Biological evaluation ofmedical devices -Part 1:Evaluation and testingwithin a risk managementprocess."	Biocompatibility risk managementanalysis was conducted per ISO10993-1 of the materials andmanufacturing methods to legallymarketed predicate devices.	N/A
Blank sizes(mm)	Disc:	Disc sizes
	95-110mm x 10-30mm	98.5 x 10-30mm

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Image /page/5/Picture/0 description: The image shows the logo for United Dental Resources. The logo features the word "UNITED" in white, bold letters on a blue rectangular background. Below "UNITED" are the words "DENTAL RESOURCES" in a smaller font. The blue rectangle is set against a red background, which is angled to the left and extends beyond the blue rectangle on both sides.

GenesisZr™ 4Y Zirconia blank comparison to the predicate device, Glidewell Prismatik™ Clinical Zirconia (Prismatik™ CZ) (K060104), is based upon similar characteristics such as: intended use, indications, contra-indications, material properties, chemical composition,

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Image /page/6/Picture/0 description: The image shows the logo for United Dental Resources. The logo features the word "UNITED" in white, bold, sans-serif font on a blue rectangular background. Below "UNITED" is the phrase "DENTAL RESOURCES" in a smaller, white, sans-serif font. The blue rectangle is placed on top of a red shape that resembles a parallelogram, and the entire logo is slightly tilted.

processing/fabrication and testing to recognized standards and guidelines. GenesisZr™ utilizes a greater composition of Y>O3 which is added for extra translucency, but results in a fracture toughness of 3.5 MPa m85, therefore limiting the device to 3-unit bridges based on the ISO 6872 standard. This has been noted in our Indications for Use. However, this difference due to the addition of a specification in the Indications for Use does not affect substantial equivalence. Additionally, since Indication for Use statements now note prescription requirements on the form, that has not been included in our Indications for Use statement. It is noted in the Instructions for Use and on the device labeling.

Both the subject device and predicate device are provided in disc shape of various sizes. The disc size of the GenesisZr™ Zirconia blanks are minor and do not affect substantial equivalence. The subject and predicate device have similar physical/mechanical properties that met the requirements of ISO 6872.

7. Nonclinical Testing

United Dental Resources Corporation performed a series of tests. Sintered tests coupled with mechanical bench testing confirmed that the device meets specifications including established international standards and guidance documents. Density, bending strength, fracture toughness, chemical solubility and material characterization/ composition of finished product was conducted while meeting performance goals established by standards. GenesisZr™ 4Y Zirconia blanks comply with ISO 6872:2008, "Dentistry - Ceramic materials" and ISO 13356: 2008, "Implants for surgery, Ceramic materials based on yttriastabilized tetragonal zirconia (Y-TZP)". A risk management evaluation was done in which the materials, manufacturing processes and use were evaluated per the FDA Guidance, Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on June 16, 2016.

8. Clinical Testing

Clinical tests have not been performed.

Conclusion: GenesisZr™ 4Y Zirconia blank comparison to the predicate device. 9. Glidewell Prismatik™ Clinical Zirconia (Prismatik™ CZ) (K060104), is based upon similar characteristics such as: intended use, indications, contra-indications, material properties, chemical composition, processing/fabrication and testing to recognized standards and quidelines, United Dental Resources believes that GenesisZr™ 4Y Zirconia blanks are substantially equivalent to legally marketed 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.