EthanZirM Ziconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures. crowns and bridges). EthanZirM Zirconia blanks are intended to be milled and fully sintered by a Dental Professional or Dental Laboratory before use. Full contour monolithic crowns and bridges in anterior and posterior regions. Substructure ceramic for prostheses involving four or more units can be created.

Device Description

EthanZir™ Zirconia are disc shaped dental porcelain zirconia oxide blanks that come in various sizes that are used in custom 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 custom rendered blank is milled the product 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 describes a 510(k) premarket notification for a dental device called "EthanZir™ Zirconia." This document focuses on demonstrating substantial equivalence to a predicate device based on physical and chemical properties, rather than clinical performance or AI-related metrics. Therefore, many of the requested fields regarding acceptance criteria for AI performance, sample sizes for test sets, expert ground truth, MRMC studies, and training set details are not applicable or cannot be extracted from this specific document.

However, I can extract information related to the acceptance criteria for the physical and performance characteristics of the EthanZir™ Zirconia blanks and the nonclinical testing performed to prove these specifications are met.

Here's the information that can be extracted:

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

Physical Property	Acceptance Criteria	Reported Device Performance
Sintered Density	≥ 6.09 g cm³	≥ 6.09 g cm³ (Met, implied by table)
Thermal Expansion Coefficient (20-500°C)	10.1 µm/m °C	10.1 µm/m °C (Met, implied by table)
Bending Strength	> 900 MPa	> 900 MPa (Met, implied by table)
Grain size	0.45 μm	0.45 μm (Met, implied by table)
Fracture toughness	5 MPam0.5	5 MPam0.5 (Met, implied by table)

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

Sample Size for Test Set: Not explicitly stated. The document mentions "Sintered tests coupled with mechanical bench testing" and "Density, bending strength, fracture toughness, chemical solubility and material characterization/composition of finished product was conducted." However, the number of samples or specimens tested is not provided.
Data Provenance: Not specified regarding country of origin or whether it was retrospective/prospective. The tests were performed by "Besorah Dental Solutions."

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

Not Applicable. This document describes the physical and chemical testing of a material, not the performance of an AI algorithm requiring expert-established ground truth from medical images.

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

Not Applicable. This document describes material testing, not the evaluation of an AI algorithm with multiple human readers.

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:

No. A MRMC comparative effectiveness study was not done. This device is a dental material, not an AI-assisted diagnostic tool.

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

Not Applicable. This is a dental material, not an algorithm.

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

The "ground truth" or reference standards for the material testing would be established by controlled laboratory measurements using calibrated equipment and following international standards (ISO 6872:2008 and ISO 13356: 2008).

8. The sample size for the training set:

Not Applicable. This document does not describe an AI/machine learning model, so there is no training set.

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

Not Applicable. As there is no AI model, there is no training set ground truth.

Summary of Device Performance Proof:

The document states: "Besorah Dental Solutions performed a series of tests to assess whether the device is safe and effective to use. 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 to confirm that the product is safe and effective, while meeting performance goals established by standards. EthanZir™ Zirconia blanks comply with ISO 6872:2008, "Dentistry - Ceramic materials" and ISO 13356: 2008, "Implants for surgery, Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)"."

In essence, the "study" proving the device meets the acceptance criteria consisted of nonclinical laboratory bench testing to measure the physical and chemical properties of the EthanZir™ Zirconia blanks against the specified international standards. No clinical testing or AI performance evaluation was conducted or needed for this type of device submission.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

November 4, 2019

Besorah Dental Solutions NZ Limited % Robin Carden President / CEO RAC Corporation 27134 Paseo Espada San Juan Capistrano, California 92675

Re: K191304

Trade/Device Name: EthanZir Zirconia Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: Class II Product Code: EIH Dated: August 5, 2019 Received: August 7, 2019

Dear Robin Carden:

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

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

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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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,

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

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

Image /page/2/Picture/1 description: The image shows the logo for Besorah Dental Solutions NZ Limited. The logo features a stylized fern frond next to the company name. Below the logo, the text "Section 4: Indications for Use Statement" is displayed in a larger font size.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K191304

Device Name EthanZirTM Zirconia

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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."

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

17/9 Chonny Crescent, Manurewa, Auckland, New Zealand -2102 Phone: +64211268337

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows a stylized logo. The logo features a fern frond on the left side, with its leaflets clearly defined. To the right of the fern is a curved shape resembling a letter 'D' or a crescent moon. The fern and the curved shape are both in black, creating a simple yet distinctive design.

K191304

510(k) Summary

for

BESORAH DENTAL SOLUTIONS NZ, LTD

EthanZir™ Zirconia

1. Submitter

BESORAH DENTAL SOLUTIONS NZ LIMITED

17/9 Chonny Crescent, Manurewa, Auckland, New Zealand, 2102

Phone: +64211268337

Device Name 2.

Proprietary Name: EthanZir™ Zirconia Common/Usual Name: Powder, Porcelain Porcelain powder for clinical use Classification Name: K191304/S001 Prior submission #:

3. Predicate Devices

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

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

Image /page/4/Picture/1 description: The image shows a black and white logo. The logo features a fern leaf on the left side and a crescent shape on the right side. The fern leaf is depicted with its characteristic fronds, and the crescent shape is positioned to partially encircle the fern leaf.

4. A. Indications for Use

EthanZir™ Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns and bridges). EthanZir™ Zirconia blanks are intended to be milled and fully sintered by a Dental Professional or Dental Laboratory before use. Full contour monolithic crowns and bridges in anterior and posterior regions. Substructure ceramic for prostheses involving four or more units can be created.

B. Classification regulation 21 CFR 872.6660, Class II, product code EIH

5. Device Description and Function

6. Physical and Performance Characteristics

Design:

CAD CAM design

Material Used:

EthanZir™ Zirconia blanks are composed of zirconia ceramics (ZrO2) based on yttria-stabilized tetragonal zirconia (Y-TZP). The material is biocompatible according to ISO 10993-1: 2009 "Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".

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

Image /page/5/Picture/1 description: The image shows a logo with two distinct elements. On the left, there is a stylized fern frond, depicted in black with a series of parallel lines forming the leaflets. To the right of the fern, there is a large, curved shape resembling a crescent or a partial letter 'D', also in black. The two elements are positioned close together, creating a unified design.

Physical Properties:

Tabulated chart of finished product "EthanZir™ Zirconia" blanks

Sintered Density	≥ 6.09 g cm³
Thermal Expansion coefficient (20-500°C)	10.1 µm/m °C
Bending Strength	> 900 MPa
Grain size	0.45 μm
Fracture toughness	5 MPam0.5

Chemical Properties:

7. Nonclinical Testing

Besorah Dental Solutions performed a series of tests to assess whether the device is safe and effective to use. Sintered tests coupled with mechanical bench testing confirmed that the device meets specifications including established international standards and quidance documents. Density, bending strength, fracture toughness, chemical solubility and material characterization/composition of finished product was conducted to confirm that the product is safe and effective, while meeting performance goals established by standards. EthanZir™ 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)".

8. Clinical Testing

Clinical tests have not been performed.

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

Image /page/6/Picture/1 description: The image shows a logo that combines a stylized fern frond with a letter 'D'. The fern frond is on the left side of the image and is depicted with a series of small, pointed leaves extending from a central stem. The letter 'D' is on the right side of the image and is a bold, curved shape that partially encloses the fern frond. The logo is simple, modern, and nature-inspired.

Conclusion: EthanZir™ Zirconia blank comparison to the predicate device 9. Glidewell Prismatik™ Clinical Zirconia (Prismatik™ CZ K060104) and is based upon similar characteristics such as: intended use, indications, contra-indications, material properties, chemical composition, processing/fabrication and testing to recognized standards and guidelines, Besorah Dental Solutions believes that EthanZir™ Zirconia blanks are substantially equivalent to these 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.