(228 days)
GenesisZr® 4Y+(ST1100) Zirconia blanks are indicated for use by dental technicians for the production of full contour and substructures restorations up to a full arch.
GenesisZr® 4Y+ (ST1100) 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, bridge or coping.
The provided text is a 510(k) Premarket Notification for a dental device, GenesisZr® 4Y+(ST1100) Zirconia. This document focuses on demonstrating substantial equivalence to a predicate device based on physical, chemical, and performance characteristics, rather than clinical efficacy studies. Therefore, it does not describe an acceptance criteria table, a study proving device performance in a clinical setting, or details related to AI/human-in-the-loop studies.
Instead, the document details nonclinical testing to demonstrate the device meets established specifications and international standards for dental ceramic materials.
Here's an analysis of the provided text based on your request, highlighting what is present and what is absent:
Device: GenesisZr® 4Y+(ST1100) Zirconia
The provided document describes a premarket notification (510(k)) for a dental material, specifically zirconia blanks used for dental restorations. This type of submission relies on demonstrating substantial equivalence to a previously cleared predicate device, primarily through nonclinical testing, material characterization, and adherence to recognized standards. It typically does not involve clinical studies or human-in-the-loop performance evaluations as would be expected for a diagnostic AI device.
Therefore, the requested information regarding acceptance criteria for clinical performance, sample size for test sets/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance for an AI device is not applicable to this document.
However, I can extract information related to the device's physical and performance characteristics, which serve as its "acceptance criteria" in the context of this 510(k) submission, and how its performance against these criteria was "proven" through nonclinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are its physical and chemical properties, as measured through laboratory testing, and its compliance with relevant ISO standards.
| Characteristic | Acceptance Criteria (from ISO standards / industry norms) | Reported Device Performance (GenesisZr® 4Y+(ST1100) Zirconia) | Predicate Device Information (ArgenZ HT+) |
|---|---|---|---|
| Physical Properties: | |||
| Sintered Density | ≥ 6.0 g/cm³ (ISO 13356:2015 Section 4.1 Req't.) | ≥ 6.07 g/cm³ (Reported: 6.07 g/cm³) | 6.08 g/cm³ |
| Thermal Expansion Coefficient (20-500°C) | No specific requirement stated in table (ISO 6872:2015) | 10.2 µm/m °C | 10.3 µm/m °C |
| Bending Strength (average flexural strength) | > 800 MPa (ISO 6872:2015 Limit) | 1,100 MPa | 1,348 MPa |
| Grain size | Not explicitly stated as acceptance criteria | 0.66 µm | Not supplied |
| Fracture Toughness (KIC) | ≥ 5.0 MPa m^(0.5) (ISO 6872:2015 Annex A; minimum for class 5) | > 5.0 MPa m^(0.5) | Not supplied |
| Chemical Properties: | |||
| Material Composition (ZrO2 + HfO2 + Y2O3 + Al2O3) | > 99.0% | > 99.0% | ZrO2+HfO2+Y2O3: > 99 wt% |
| Al2O3 | ≤ 0.05% | ≤ 0.05% | Not specified |
| SiO2 | ≤ 0.01% | ≤ 0.01% | Not specified |
| Fe2O3 | ≤ 0.01% | ≤ 0.01% | Not specified |
| Chemical Solubility | < 100 µg/cm² (ISO 6872:2015 Limit) | 8.229 µg/cm² | 66.11 µg/cm² |
| Freedom from extraneous materials (Uranium238) | < 1.0 Bq g-1 (ISO 6872:2015 Section 5.2) | < 0.03 | Not supplied |
| Biocompatibility | Compliance with ISO 10993-1: Part 1 | Assured through use of same material composition and manufacturing process as predicate device. | Compliance with ISO 10993-1: Part 1 |
Note: The "acceptance criteria" here are largely derived from the requirements of the cited ISO standards (ISO 6872:2015 "Dentistry - Ceramic materials" and ISO 13356:2015 "Implants for surgery, Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)"). The device's reported performance data are directly compared against these standards to demonstrate compliance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample sizes (e.g., number of specimens tested) for each physical and chemical property test. It states that "United Dental Resources Corporation performed a series of tests" and that "sintered tests coupled with mechanical bench testing confirmed that the device meets specifications."
- Data Provenance: The data is generated from nonclinical bench testing conducted by the manufacturer, United Dental Resources Corporation. The provenance is internal to the company for the purpose of this regulatory submission. The document does not mention the country of origin of the raw data beyond the company's address (University Park, Illinois 60484, USA). The testing is retrospective in the sense that it was completed prior to the 510(k) submission, but it's not retrospective clinical data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This submission is for a material device, not an AI diagnostic tool or a device requiring subjective interpretation by human experts to establish ground truth for performance. The "ground truth" for this device lies in its measurable physical and chemical properties and compliance with engineering standards.
4. Adjudication Method for the Test Set
- Not Applicable. As there are no human readers or subjective interpretations, there is no need for an adjudication method. Performance is determined by objective laboratory measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This type of study is relevant for diagnostic imaging devices or AI tools where human reader performance is a key metric. For a dental ceramic material, MRMC studies are not applicable. The document states: "Clinical tests have not been performed."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This term is only relevant for software/AI devices. The GenesisZr® 4Y+(ST1100) Zirconia is a physical material blank.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is based on objective measurements of physical and chemical properties against established international standards (ISO 6872:2015 and ISO 13356:2015). This is a form of engineering/material specification compliance. It is not expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
- Not Applicable. This is not a machine learning or AI device, so there is no "training set." The device is a manufactured product with defined material properties.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. See point 8.
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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.
February 23, 2021
John Von Thaden, Operations Officer United Dental Resources Corporation 70 Towncenter Drive University Park, Illinois 60484
Re: K201915
Trade/Device Name: GenesisZr 4Y+(ST1100) Zirconia Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: October 10, 2020 Received: October 14, 2020
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 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
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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 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.
Michael E. Adiodha. 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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Indications for Use
510(k) Number (if known) K201915
Device Name
GenesisZr® 4Y+(ST1100) Zirconia
Indications for Use (Describe)
GenesisZn® 4Y+(ST1100) Zirconia blanks are indicated for use by dental technicians for the production of full contour and substructures restorations up to a full arch.
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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enesisZr® 4Y+ (ST1100) ZIRCONIA 510(k) Premarket Submission
Section 5: 510(k) Summary
Page 13 of 84
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510(k) Summary
for
United Dental Resources Corporation
GenesisZr® 4Y+ (ST1100) Zirconia
1. Submitter
Owners Name: United Dental Resources Corporation Address: 70 Towncenter Drive University Park, IL 60484
| Phone: | (708) 746-5730 |
|---|---|
| Fax: | (888) 503-2190 |
Contact Person:
John Von Thaden, Operations Officer
January 21, 2020
Date summary prepared:
2. Device Name
Proprietary Name: Common/Usual Name: Classification Name: Product Code: Requlation Number: Device Class:
GenesisZr® 4Y+ (ST1100) Zirconia Powder, Porcelain Porcelain powder for clinical use EIH 21 DFR 872.6660 Class II
3. Predicate Device
The Argen Corporation, ArgenZ HT+ (K190079)
4. Indications for Use
GenesisZr® 4Y+ (ST1100) Zirconia blanks are indicated for use by dental technicians for the production of full contour and substructures restorations up to a full arch.
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enesisZr® 4Y+ (ST1100) ZIRCONIA 510(k) Premarket Submission
Section 5: 510(k) Summary
Page 14 of 84
5. Device Description and Function
GenesisZr® 4Y+ (ST1100) 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, bridge or coping.
6. Physical and Performance
Characteristics Design:
As described in Section 5.0 above - Device Description and Function
Material Used:
GenesisZr® 4Y+ (ST1100) 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"
Physical Properties:
Tabulated chart of finished product "GenesisZr® 4Y+ (ST1100) Zirconia" blanks (see next page)
| Sintered Density | ≥ 6.07 g/cm³ |
|---|---|
| Thermal Expansion coefficient (20-500°C) | 10.2 µm/m °C |
| Bending Strength | 1,100 MPa |
| Grain size | 0.66 µm |
| Fracture toughness | >5.0 MPam0.5 |
Chemical Properties:
| Component (chemicalcomposition) | GenesisZr® 4Y+ (ST1100) Zirconia(percentage by wt.) |
|---|---|
| ZrO2 + HfO2 + Y2O3+ Al2O3 | > 99.0 |
| Al2O3 | ≤ 0.05 |
| SiO2 | ≤ 0.01 |
| Fe2O3 | ≤ 0.01 |
| Chemical solubility | < 100 µg/cm2 |
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r® 4Y+ (ST1100) ZIRCONIA 510(k) Premarket Submission
Image /page/5/Picture/1 description: The image shows a logo for United Dental Resources. The logo features the word "UNITED" in white letters on a blue rectangular background. The words "DENTAL RESOURCES" are in a smaller font below the word "UNITED". The blue rectangle is placed on top of a red diamond shape.
Section 5: 510(k) Summary
7. Nonclinical Testing
United Dental Resources Corporation 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.
GenesisZr® 4Y+ (ST1100) 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® 4Y+ (ST1100) Zirconia blank comparison to the predicate device, The Argen Corporation, ArgenZ HT+ (K190079), 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® 4Y+ (ST1100) Zirconia utilizes a substantially equivalent composition (ZrO2+HfO2+Y2Os: > 99), which results in a flexural strength of >1,100MPa and a fracture toughness of >5.0 MPa m0.5, therefore allowing for a classification of Class 5 in the ISO 6872:2015 standard. Thus the product meets the standards for "Monolithic-ceramic for prostheses involving four or more units or fully covered substructure for prostheses involving four or more units."
The predicate device's Indications for Use provide for "the production of full contour and substructure restorations up to a full arch" and the subject device also meets the standards for this same indication based upon the specification with ISO 6872:2015, Section 4 and Annex A.
Additionally, while indication for Use statements now note prescription requirements on the form, we have still indicated the device is for use by dental technicians. We have also noted the prescription requirements in the Instructions for Use (Section 13) and on the device labeling (Section 13). Both the subject device and predicate device
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enesisZr® 4Y+ (ST1100) ZIRCONIA 510(k) Premarket Submission Section 5: 510(k) Summary Page 16 of 84
are provided in disc shapes of various sizes.
The subject and predicate device have similar physical/mechanical properties that meet the requirements of ISO 6872:2015.
GenesisZr® 4Y+ (ST1100) Zirconia Biocompatibility has been assured through the use of the same material composition and the same manufacturing process as the Predicate device.
| GenesisZr® 4Y+ (ST1100)Zirconia | ArgenZ HT+Argen/K190079 | |
|---|---|---|
| Indications for use | GenesisZr® 4Y+ (ST1100) Zirconiablanks are indicated for use bydental technicians for theproduction of full contour andsubstructures restorations up to afull arch. | ArgenZ HT+ (high translucent plus)zirconia can be used for theproduction of full contourand substructures restorations up toa full arch. |
| Contra- Indications | When GenesisZr® 4Y+ (ST1100)Zirconia blanks are milled, thedental technician should takeappropriate safety methods suchas face mask and eye protectionwhen removing the finished dentalprostheses from the holder topreclude inhaling dust particlesupon removal with power tools.• Insufficient tooth structurereduction.1• Insufficient tooth structure forproper adhesion and forcedistribution.1• Insufficient oral hygiene.• Insufficient interproximal spacefor sufficient joints in bridges.1• Known allergies.1• Known incompatibilities toproduct composition.1• Heavy discoloration of preppedtooth structure.11 as applicable to the finished articleinstalled by the dentist | There are no specific contra-indications identified. |
| GenesisZr® 4Y+ (ST1100)Zirconia | ArgenZ HT+Argen/K190079 | |
| Material Composition% wt. | Zirconia Powder:ZrO2+HfO2+Y2O3: > 99 wt%Inorganic Pigments < 1% | Zirconia Powder:ZrO2+HfO2+Y2O3: > 99 wt%Inorganic Pigments < 1% |
| Freedom fromextraneous materialsper ISO6872:2015Section 5.2active conc. of notmore than 1.0 Bq g-1of Uranium238 | <0.03 | Not supplied |
| Blank sizes (mm) | Disc:98.5 O.D. x 10-30mm | Disc:Sizes not identified. |
| Sintered Densityg/cm3, ISO 13356:2015 Section 4.1Req't. of ≥ 6.0 | 6.07 g/cm³ | 6.08 g/cm³ |
| Coefficient of thermalexpansion (CTE) ISO6872: 2015, No req't. | 10.2 µm/m °C | 10.3 µm/m °C |
| Fracture toughnessKIC ISO 6872:2015Annex A; minimumfor class 5, 5.0 MPam1/2 | >5.0 MPa m1/2 | Not supplied |
| Average Flexuralstrength per ISO6872:2015, Limit>800MPa | 1,100 MPa | 1,348 MPa |
| Chemical solubilityper ISO 6872:2015,Limit 100 µg/cm2 | 8.229 µg/cm2 | 66.11 µg/cm2 |
| Biocompatibility perISO 10993-1: Part 1 -'Biological evaluationof medical devices -Part 1: Evaluationand testing within arisk managementprocess. | ||
| GenesisZr® 4Y+ (ST1100)Zirconia | ArgenZ HT+Argen/K190079 | |
| ManufacturingProcess | Composition Material isacquired in powder form.Ceramic blanks are produced bycompression. Thesecompressed blanks are thenpartially sintered (fired) at hightemperatures, which is the samemanufacturing process used inthe industry to fabricate similardevices. | Composition Material is acquired inpowder form. Argen HT+ is apressed Yttria stabilized Zirconia.The raw materials and manufacturingprocess used in the fabrication ofArgen HT+ are similar to thematerials and processes used in theindustry to fabricate the predicatedevices. |
| Safety and Efficacy ofthe Device | The device functions in a similarmanner to other comparativedevices and the intended use isthe same. The differencesbetween comparative devicesare minor and do not raise newsafety concerns. Theeffectiveness and suitability ofthe device for the intendedpurpose is assured throughwide, general use of similarother predicate devices thatdemonstrate the safe use of thedevice to construct dentalrestorations. | Statement Not Supplied |
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GenesisZr® 4Y+ (ST1100) ZIRCONIA 510(k) Premarket Submission
Image /page/7/Picture/1 description: The image shows a logo for United Dental Resources. The logo features the word "UNITED" in white, bold letters on a blue rectangular background. Below "UNITED" is the phrase "DENTAL RESOURCES" in smaller, white letters. The blue rectangle is set against a larger red shape, which appears to be a parallelogram tilted slightly to the right.
Section 5: 510(k) Summary
Page 17 of 84
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GenesisZr® 4Y+ (ST1100) ZIRCONIA 510(k) Premarket Submission
Image /page/8/Picture/1 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" are the words "DENTAL RESOURCES" in a smaller, white, sans-serif font, also on the blue background. The blue rectangle is placed diagonally on a red background, which is also rectangular.
Section 5: 510(k) Summary
Page 18 of 84
10. Conclusion:
GenesisZr® 4Y+ (ST1100) Zirconia blank comparison to the predicate device, ArgenZ HT+ (K190079), 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. United Dental Resources has concluded that GenesisZr® 4Y+ (ST1100) 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.