(227 days)
GenesisZr® UHT700 Zirconia blanks are indicated for Monolitic-ceramic for single-unit anterior or posterior prostleses and for three-unit prostheses not involving molar restoration, adhesively cemented. Also indicated for fully covered substructure for single-unit anterior or posterior prostheses and for three-unit prostheses not involving molar restoration_adhesively, or non-adhesively cemented.
GenesisZr® UHT700 Zirconia are disc and block 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 a crown.
The provided text describes the 510(k) Premarket Submission for GenesisZr® UHT700 Zirconia. This submission focuses on demonstrating substantial equivalence to a predicate device (CCRI, Inc., Pavati® Z40.2 (K160867)) primarily through non-clinical testing of physical, chemical, and material properties, and comparison of manufacturing processes and indications for use.
Crucially, no information about a study proving the device meets acceptance criteria for an AI or software algorithm is present in this document. The document pertains to a dental material (zirconia blanks) and its physical and chemical properties, not a software device requiring performance metrics like accuracy, sensitivity, or specificity.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment for a test set or training set. This document does not describe such a study for this medical device.
The only "performance" discussed relates to the material's physical and chemical properties as measured against established dental material standards (ISO 6872:2015 and ISO 13356:2015).
Here's a breakdown of what is available in the document regarding the device's characteristics, which are the basis for its clearance, but not an AI/ML study:
The available document details the non-clinical testing performed to demonstrate substantial equivalence of the GenesisZr® UHT700 Zirconia blanks to the predicate device, Pavati® Z40.2 (K160867). This is a material science characterization, not a performance study of a diagnostic or therapeutic device with AI/ML components.
Here's the relevant information about the acceptance criteria and the "study" (non-clinical testing) that proves the device meets these criteria in the context of a dental material:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by international standards for dental ceramic materials (ISO 6872:2015 and ISO 13356:2015) and comparison to the predicate device's properties. The "performance" reported is the measured physical and chemical properties of the GenesisZr® UHT700 Zirconia.
| Property | Acceptance Criteria (from ISO standards / Predicate) | Reported GenesisZr® UHT700 Zirconia Performance |
|---|---|---|
| Sintered Density (g/cm³) | ≥ 6.0 (ISO 13356:2015, Sec. 4.1 Req't.) | 6.04 |
| Thermal Expansion Coefficient (20-500°C) | Comparable to predicate (10.3 µm/m °C) | 10.2 µm/m °C |
| Bending Strength (MPa) | > 600 MPa (and comparable to predicate) | 600 MPa |
| Chemical Solubility (µg/cm²) | < 100 (ISO 6872:2015) | Meets ISO Standard (< 100) |
| Grain size | Not specified as an explicit acceptance criteria comparison, but reported. | 0.66 µm |
| Fracture toughness (MPa m0.5) | > 2.0 (and comparable to predicate) | 2.4 |
| ZrO2 + HfO2 + Y2O3+ Al2O3 (%) | > 99.9 | > 99.9 |
| Y2O3 (%) | 9.85% ±0.65 | 9.85% ±0.65 |
| Al2O3 (%) | ≤ 0.1 | ≤ 0.01 |
| SiO2 (%) | ≤ 0.02 | ≤ 0.02 |
| Fe2O3 (%) | ≤ 0.01 | ≤ 0.01 |
| HfO2 (%) | ≤ 5.0 | Not explicitly listed, but implied by total ZrO2+HfO2+Y2O3+Al2O3 > 99.9 |
| Freedom from extraneous materials (Uranium238 Bq g-1) | < 1.0 (ISO 6872:2015 Section 5.2) | < 0.03 |
2. Sample size used for the test set and the data provenance:
This document describes non-clinical bench testing of material properties, not testing on human subjects or clinical data. Therefore, the concept of "test set sample size" in the context of an AI/ML study is not applicable. The sample sizes for the material property tests (e.g., number of specimens for bending strength) are not specified in this summary, but would be standard for material characterization.
- Data Provenance: The data comes from "sintered tests coupled with mechanical bench testing" performed by United Dental Resources Corporation. The location/country of origin of this testing is not specified, nor is whether it was retrospective or prospective in conventional clinical study terms, as it's lab testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth for material properties is established by physical and chemical measurements using validated laboratory methods and instruments, not by expert human interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is not a study involving human readers or interpretation requiring adjudication.
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 therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. No algorithm is involved.
7. The type of ground truth used:
The ground truth used for this device's non-clinical testing is measured physical and chemical properties validated against established international standards (ISO 6872:2015, ISO 13356:2015).
8. The sample size for the training set:
Not applicable. There is no AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. There is no AI/ML algorithm requiring a training set.
In summary, the provided document details a 510(k) submission for a dental material based on substantial equivalence through non-clinical laboratory testing and comparison to an existing predicate device, not through clinical studies of an AI-powered device.
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Image /page/0/Picture/0 description: The image shows 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 acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
January 28, 2021
United Dental Resources Corporation John Thaden Operation Officer 70 Towncenter Drive University Park, Illinois 60417
Re: K201608
Trade/Device Name: GenesisZr UHT700 Zirconia Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: Class II Product Code: EIH Dated: January 21, 2021 Received: January 25, 2021
Dear John 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
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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,
Michael E. Adjodha, M.ChE. Assistant 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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Image /page/2/Picture/0 description: The image shows the logo for United Dental Resources. The logo consists of a blue rectangle with the word "UNITED" in white, block letters on the top line and the words "DENTAL RESOURCES" in smaller, white letters on the bottom line. The blue rectangle is placed diagonally on top of a red parallelogram, which is slightly larger than the rectangle.
GenesisZr UHT700 ZIRCONIA 510(k) Premarket Submission
Section 4: Indications for Use Statement
Page 11 of 80
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) K201608
Device Name GenesisZr UHT700 Zirconia
Indications for Use (Describe)
GenesisZr UHT700 Zirconia blanks are indicated for Monolitic-ceramic for single-unit anterior or posterior prostleses and for three-unit prostheses not involving molar restoration, adhesively cemented. Also indicated for fully covered substructure for single-unit anterior or posterior prostheses and for three-unit prostheses not involving molar restoration_adhesively, or non-adhesively cemented.
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)
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GenesisZr UHT700 ZIRCONIA 510(k) Premarket Submission
Section 5: 510(k) Summary
Image /page/3/Picture/2 description: The image shows the logo for United Dental Resources. The logo consists of a red parallelogram in the background with a blue rectangle in the foreground. The word "UNITED" is written in white, uppercase letters on the blue rectangle, with the words "DENTAL RESOURCES" written in a smaller font size below the word "UNITED".
Page 12 of 80
Section 5:
510(k) Summary
for
United Dental Resources Corporation
GenesisZr® UHT700 Zirconia
- Submitter
Owners Name:
Address:
United Dental Resources Corporation
70 Towncenter Drive University Park, IL 60484
Phone: (708) 746-5730 (888) 503-2190 Fax:
Contact Person:
John Von Thaden, Operations Officer
Date summary prepared: January 21, 2021
2. Device Name
Proprietary Name: Common/Usual Name: Classification Name: Product Code: Regulation Number: Device Class:
GenesisZr® UHT700 Zirconia Powder, Porcelain Porcelain powder for clinical use EllH 21 DFR 872.6660 Class II
3. Predicate Device
CCRI, Inc., Pavati® Z40.2 (K160867)
4. Indications for Use
GenesisZr® UHT700 Zirconia blanks are indicated for Monolithic-ceramic for singleunit anterior or posterior prostheses and for three-unit prostheses not involving molar restoration, adhesively, or non-adhesively cemented. Also indicated for fully covered substructure for single-unit anterior or posterior prostheses and for three-unit prostheses not involving molar restoration, adhesively, or non-adhesively cemented.
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Image /page/4/Picture/1 description: The image shows the logo for United Dental Resources. The logo consists of the word "UNITED" in white letters on a blue rectangular background, with the words "DENTAL RESOURCES" in smaller white letters underneath. The blue rectangle is placed on top of a red parallelogram, which is tilted to the right. The logo has a registered trademark symbol.
5. Device Description and Function
GenesisZr® UHT700 Zirconia are disc and block 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 a crown.
6. Physical and Performance Characteristics
Design:
As described in Section 5.0 Device Description and Function
Material Used:
GenesisZr® UHT700 Zirconia blanks are composed of zirconia ceramics (ZrO2) based on yttria-stabilized tetragonal zirconia (Y-TZP). The material is biocompatible according to ISO 10993-1:2018 "Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
Physical Properties:
Tabulated chart of finished product "GenesisZr® UHT700 Zirconia" blanks
| Sintered Density | $\geq$ 6.04 g cm3 |
|---|---|
| Thermal Expansion coefficient (20-500°C) | 10.2 µm/m °C |
| Bending Strength | > 600 MPa |
| Grain size | 0.66 µm |
| Fracture toughness | 2.4 MPa m0.5 |
Chemical Properties:
| Component (chemicalcomposition) | GenesisZr® UHT700 Zirconia(percentage by wt.) |
|---|---|
| ZrO2 + HfO2 + Y2O3+ Al2O3 | > 99.9 |
| Y2O3 | 9.85% ±0.65 |
| Al2O3 | ≤ 0.01 |
| SiO2 | ≤ 0.02 |
| Fe2O3 | ≤ 0.01 |
| Chemical solubility | < 100 µg/cm2 |
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Image /page/5/Picture/1 description: The image shows the logo for United Dental Resources. The logo features the word "UNITED" in blue, stacked above the words "DENTAL RESOURCES" in a smaller font. The text is set against a red, white, and blue background, with the red portion appearing as a diagonal stripe behind the blue text.
7. Nonclinical Testing
United Dental Resources Corporation performed a series of tests to assess whether the device is as safe and effective as the predicate device. 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 were conducted to confirm that the product is substantially equivalent in safety and effectiveness, while meeting performance goals established by standards.
GenesisZr® UHT700 Zirconia blanks comply with ISO 6872:2015, "Dentistry -Ceramic materials" and ISO 13356:2015, "Implants for surgery, Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)".
8. Clinical Testing
Clinical tests have not been performed.
9. Substantial Equivalence Discussion
GenesisZr® UHT700 Zirconia blank comparison to the predicate device, CCRI, Inc., Pavati® Z40.2 (K160867), 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. GenesisZr® UHT700 Zirconia utilizes an identical composition which results in an identical flexural strength of >600MPa and a fracture toughness of 2.4 MPa m0.5, therefore limiting the device to 3-unit bridges based on the ISO 6872 standard. This has been noted in our Indications for Use. It should also be noted that the predicate device has the same contraindications for 3-unit prostheses involving molars, but the contraindication is in the directions for use for the predicate and we have opted to include it in the Indications for Use for the subject device for increased clarity. 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 shapes of various sizes. The disc size variation of the GenesisZr® UHT700 Zirconia blanks are minor and do not affect substantial equivalence.
The subject and predicate device have similar physical/mechanical properties that meet the requirements of ISO 6872:2015.
GenesisZr® UHT700 Zirconia Biocompatibility has been assured through the use of the exact same material composition and the exact same manufacturing process as the Predicate device.
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GenesisZr® UHT700 ZIRCONIA 510(k) Premarket Submission
Image /page/6/Picture/1 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 size. The blue rectangle is placed diagonally on top of a larger red shape, which appears to be a parallelogram.
Section 5: 510(k) Summary
Page 15 of 80
| GenesisZr® UHT700Zirconia | Pavati® Z40.2 (K160867) | |
|---|---|---|
| Indications for use | GenesisZr UHT700 Zirconiablanks are indicated forMonolithic-ceramic for single-unit anterior or posteriorprostheses and for three-unitprostheses not involving molarrestoration, adhesively, or non-adhesively cemented. Alsoindicated for fully coveredsubstructure for single-unitanterior or posterior prosthesesand for three-unit prostheses notinvolving molar restoration,adhesively, or non-adhesivelycemented. | Pavati® Z40.2 Zirconia blanksare indicated for use inprostheticdentistry to create porcelain(ceramic) prostheses (crowns)in the anterior/ posteriorapplications.Pavati™ Zirconia blanks areintended to be milled and fullysintered by Dental Professionalor Dental Laboratory before use.Pavati™ Zirconia blanks are for"Rx only" and not for use by thegeneral public or sold as “Over-the- Counter". |
| Contra- Indications | Class 4 & 5 indications cannotbe made with this device. WhenGenesisZr® UHT700 Zirconiablanks are milled, do not inhaledust when removing dentalprosthesis from dental holder.Take appropriate safetymethods such as face mask andeye protection. | The Device is contraindicated fordental restorations greater than3-units in length (per ISO6872:2015 and the same asreference device #1)The device is contraindicated for3 unit prostheses involving molarrestorations (per ISO6872:2015). Class 4 & 5indications cannot be made withthis device. |
| MaterialComposition% wt.According to ISO13356:2015Sec. 3, Table 1 | Zirconia Powder:ZrO2+HfO2+Y2O3+Al2O3: > 99.9HfO2: ≤ 5.0Y2O3: 9.85% ±0.65Al2O3: ≤ 0.1SiO2: ≤ 0.02Fe2O3: ≤ 0.01 | Zirconia Powder:ZrO2+HfO2+Y2O3+Al2O3: > 99.9HfO2: ≤ 5.0Y2O3: 9.85% ±0.65Al2O3: ≤ 0.1SiO2: ≤ 0.02Fe2O3: ≤ 0.01 |
| ManufacturingProcess | Composition Material is acquiredin powder form. Ceramic blanksare produced by compression.These compressed blanks arethen partially sintered (fired) athigh temperatures. | Composition Material is acquiredin powder form. Ceramic blanksare produced by compression.These compressed blanks arethen partially sintered (fired) athigh temperatures. |
| GenesisZr® UHT700Zirconia | Pavati® Z40.2 (K160867) | |
| Freedom fromextraneous materialsper ISO 6872:2015Section 5.2 activeconc. of not more than1.0 Bq g-1 ofUranium238 | <0.03 | Meets ISO Standard |
| Sintered Densityg/cm3ISO 13356: 2015Section 4.1 Req't.of ≥ 6.0 | 6.04 g/cm3 | ≥ 6.00 g /cm3 |
| Coefficient of thermalexpansion (CTE) | 10.2 µm/m °C | 10.3 µm/m °C |
| Fracture toughnessKic | 2.4 MPa m0.5 | >2.0 MPam0.5 |
| Flexural strength perISO 6872:2015,Limit >900MPa | 600 MPa | Meets ISO Standard |
| Chemical solubilityper ISO 6872:2015Limit 100 µg/cm2 | Meets ISO Standard | < 100 µg/cm2 |
| Biocompatibility perISO 10993-1: Part 1 –“Biological evaluationof medical devices –Part 1: Evaluation andtesting within a riskmanagementprocess.” | Assured through use of theexact same materials andmanufacturing methods aslegally marketed predicatedevices | Biocompatible and Non-toxicAssured through use of samematerials and manufacturingmethods as legally marketedpredicate devices. |
| Blank sizes(mm) | Disc:95-110mm x 10-30mm | Block: 65-85 x 40 x 1520-55 x 19 x 1540 x 15 x 1514 x 13 x 1518 x 14.5 x 12.4Near net shapesDisc: 95-110 x 12-30 |
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GenesisZr® UHT700 ZIRCONIA 510(k) Premarket Submission
Image /page/7/Picture/1 description: The image shows the logo for United Dental Resources. The logo features the word "UNITED" in large, bold, white letters on a blue rectangular background. Below "UNITED" are the words "DENTAL RESOURCES" in smaller, white letters. The blue rectangle is set against a red, triangular background, giving the logo a dynamic and eye-catching appearance.
Section 5: 510(k) Summary
Page 16 of 80
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Image /page/8/Picture/4 description: The image shows the logo for United Dental Resources. The logo features the word "UNITED" in white, sans-serif font on a blue rectangle. Below "UNITED" are the words "DENTAL RESOURCES" in a smaller, white, sans-serif font. The blue rectangle is placed on top of a red parallelogram, which is slightly rotated.
10. Conclusion:
GenesisZr® UHT700 Zirconia blank comparison to the predicate device, CCRI, Inc., Pavati® Z40.2 (K160867), 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. As such, United Dental Resources has concluded that GenesisZr® UHT700 Zirconia blanks are substantially equivalent to this legally marketed predicate device.
§ 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.