GenesisZr 4Y+ (ST1100) Zirconia

K201915 · United Dental Resources Corporation · EIH · Feb 23, 2021 · Dental

Device Facts

• Record ID: K201915
• Device Name: GenesisZr 4Y+ (ST1100) Zirconia
• Applicant: United Dental Resources Corporation
• Product Code: EIH · Dental
• Decision Date: Feb 23, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

GenesisZr 4Y+ (ST1100) Zirconia consists of yttria-stabilized tetragonal zirconia (Y-TZP) ceramic discs/blocks. Dental laboratories use CAD/CAM systems to mill these blanks into custom dental restorations (crowns, bridges, copings) based on patient tooth anatomy. Milled restorations are sintered and colored as needed before fitting by a dentist. The device is used in dental laboratory settings by technicians. The final restoration provides structural support and aesthetic replacement for missing or damaged tooth structure, benefiting patients by restoring oral function.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via mechanical testing including density, bending strength (1,100 MPa), fracture toughness (>5.0 MPa m0.5), and chemical solubility, confirming compliance with ISO 6872:2015 and ISO 13356:2015 standards.

Technological Characteristics

Material: Yttria-stabilized tetragonal zirconia (Y-TZP). Composition: ZrO2+HfO2+Y2O3 > 99 wt%. Form factor: Disc/block shapes. Processing: CAD/CAM milling followed by sintering. Standards: ISO 6872:2015 (Class 5), ISO 13356:2015, ISO 10993-1:2009 (biocompatibility).

Indications for Use

Indicated for dental technicians to produce full contour and substructure dental restorations up to a full arch.

Regulatory Classification

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.

Predicate Devices

• ArgenZ HT+ (K190079)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

| <span> <b> ☑ </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|------------------------------------------------------------------------------------|
| <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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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K201915

# 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: | [phone] |
|--------|----------------|
| Fax: | [phone] |

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 (chemical<br>composition) | GenesisZr® 4Y+ (ST1100) Zirconia<br>(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)<br>Zirconia | ArgenZ HT+<br>Argen/K190079 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | GenesisZr® 4Y+ (ST1100) Zirconia<br>blanks are indicated for use by<br>dental technicians for the<br>production of full contour and<br>substructures restorations up to a<br>full arch. | ArgenZ HT+ (high translucent plus)<br>zirconia can be used for the<br>production of full contour<br>and substructures restorations up to<br>a full arch. |
| Contra- Indications | When GenesisZr® 4Y+ (ST1100)<br>Zirconia blanks are milled, the<br>dental technician should take<br>appropriate safety methods such<br>as face mask and eye protection<br>when removing the finished dental<br>prostheses from the holder to<br>preclude inhaling dust particles<br>upon removal with power tools.<br>• Insufficient tooth structure<br>reduction.1<br>• Insufficient tooth structure for<br>proper adhesion and force<br>distribution.1<br>• Insufficient oral hygiene.<br>• Insufficient interproximal space<br>for sufficient joints in bridges.1<br>• Known allergies.1<br>• Known incompatibilities to<br>product composition.1<br>• Heavy discoloration of prepped<br>tooth structure.1<br>1 as applicable to the finished article<br>installed by the dentist | There are no specific contra-<br>indications identified. |
| | GenesisZr® 4Y+ (ST1100)<br>Zirconia | ArgenZ HT+<br>Argen/K190079 |
| Material Composition<br>% wt. | Zirconia Powder:<br>ZrO2+HfO2+Y2O3: > 99 wt%<br>Inorganic Pigments < 1% | Zirconia Powder:<br>ZrO2+HfO2+Y2O3: > 99 wt%<br>Inorganic Pigments < 1% |
| Freedom from<br>extraneous materials<br>per ISO<br>6872:2015Section 5.2<br>active conc. of not<br>more than 1.0 Bq g-1<br>of Uranium238 | <0.03 | Not supplied |
| Blank sizes (mm) | Disc:<br>98.5 O.D. x 10-30mm | Disc:<br>Sizes not identified. |
| Sintered Density<br>g/cm3, ISO 13356:<br>2015 Section 4.1<br>Req't. of ≥ 6.0 | 6.07 g/cm³ | 6.08 g/cm³ |
| Coefficient of thermal<br>expansion (CTE) ISO<br>6872: 2015, No req't. | 10.2 µm/m °C | 10.3 µm/m °C |
| Fracture toughness<br>KIC ISO 6872:2015<br>Annex A; minimum<br>for class 5, 5.0 MPa<br>m1/2 | >5.0 MPa m1/2 | Not supplied |
| Average Flexural<br>strength per ISO<br>6872:2015, Limit<br>>800MPa | 1,100 MPa | 1,348 MPa |
| Chemical solubility<br>per ISO 6872:2015,<br>Limit 100 µg/cm2 | 8.229 µg/cm2 | 66.11 µg/cm2 |
| Biocompatibility per<br>ISO 10993-1: Part 1 -<br>'Biological evaluation<br>of medical devices -<br>Part 1: Evaluation<br>and testing within a<br>risk management<br>process. | | |
| | GenesisZr® 4Y+ (ST1100)<br>Zirconia | ArgenZ HT+<br>Argen/K190079 |
| Manufacturing<br>Process | Composition Material is<br>acquired in powder form.<br>Ceramic blanks are produced by<br>compression. These<br>compressed blanks are then<br>partially sintered (fired) at high<br>temperatures, which is the same<br>manufacturing process used in<br>the industry to fabricate similar<br>devices. | Composition Material is acquired in<br>powder form. Argen HT+ is a<br>pressed Yttria stabilized Zirconia.<br>The raw materials and manufacturing<br>process used in the fabrication of<br>Argen HT+ are similar to the<br>materials and processes used in the<br>industry to fabricate the predicate<br>devices. |
| Safety and Efficacy of<br>the Device | The device functions in a similar<br>manner to other comparative<br>devices and the intended use is<br>the same. The differences<br>between comparative devices<br>are minor and do not raise new<br>safety concerns. The<br>effectiveness and suitability of<br>the device for the intended<br>purpose is assured through<br>wide, general use of similar<br>other predicate devices that<br>demonstrate the safe use of the<br>device to construct dental<br>restorations. | 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

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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

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## 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.