ArgenZ HT+

K190079 · The Argen Corporation · EIH · Apr 12, 2019 · Dental

Device Facts

• Record ID: K190079
• Device Name: ArgenZ HT+
• Applicant: The Argen Corporation
• Product Code: EIH · Dental
• Decision Date: Apr 12, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ArgenZ HT+ (high translucent plus) zirconia can be used for the production of full contour and substructure restorations up to a full arch.

Device Story

ArgenZ HT+ is a pressed Yttria-stabilized zirconia disc containing Hafnium and Aluminum oxides; used by dental laboratories to fabricate full contour and substructure dental restorations. Material is milled into final restoration shape; sintered at 1500°C. Final product provides permanent dental restoration for patients requiring tooth replacement or repair. Device is non-sterile; intended for professional use by dental technicians.

Clinical Evidence

Bench testing only. Evaluated per ISO 6872:2015 for mechanical properties (flexural strength: 1143-1348 MPa) and chemical solubility (<100 µg/cm²). Biocompatibility evaluated via ISO 10993-5 Agarose Overlay Method; no evidence of cell lysis or toxicity observed.

Technological Characteristics

Material: Yttria-stabilized Zirconia (ZrO2+HfO2+Y2O3 > 99 wt%) with inorganic pigments. Form factor: Pressed discs. Crystal morphology: Tetragonal. Sintering temperature: 1500°C. Compliance: ISO 6872 (Type II Class 5). Sterilization: Non-sterile.

Indications for Use

Indicated for the production of 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

• Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank (K180252)

Reference Devices

• Argen Pearl Brand Zirconia (K071410)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logo for "The Argen Corporation". The logo includes the text "Alloy Makers To The World" and the company name "ARGEN" in a bold font. The image also includes the company's address, which is 5855 Oberlin Drive, San Diego, CA 92121-4718, United States of America, as well as their telephone and fax numbers: [phone] and [phone], respectively.

## 510(k) Summary K190079

| Submitted by: | The Argen Corporation<br>5855 Oberlin Drive, San Diego, CA 92121<br>[phone] x471 (Phone), [phone] (FAX) |
|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact person: | Craig Jolicoeur |
| Date prepared: | 3/26/2019 |
| Trade name:<br>Common name:<br>Classification name:<br>Classification:<br>Product Code: | ArgenZ HT+<br>ArgenZ<br>Porcelain powder for clinical use (21 CFR 872.6660)<br>Class II<br>EIH |

### Legally marketed devices for which our organization is claiming substantial equivalence:

| 510(k)<br>Number | Trade Name | Manufacturer | |
|------------------|--------------------------------|-----------------------------------------------------------------------------|------------------------------------------------|
| K180252 | Primary<br>Predicate<br>Device | Crown Dental Zirconia Blank<br>& Crown Dental Zirconia Pre-<br>Shaded Blank | Crown Porcelain Dental Technology<br>Co., Ltd. |
| K071410 | Reference<br>Device | Argen Pearl Brand Zirconia | The Argen Corporation |

#### Device Description:

ArgenZ HT+ is a pressed Yttria stabilized Zirconia with primary oxides of Hafnium and Aluminum with naturally occurring trace oxides used to produce various shades.

#### Intended Use:

ArgenZ HT+ (high translucent plus) zirconia can be used for the production of full contour and substructure restorations up to a full arch.

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

#### Performance Data:

The raw materials and manufacturing process used in the fabrication of ArgenZ HT+ are similar to the materials and processes used in the industry to fabricate the predicate devices. Both materials fall into the same product classification (Class 5) per ISO 6872. Both have stated similar intended uses, chemical compositions, and physical properties. The results demonstrate compliance with the product standard and support our claim for substantial equivalence.

#### Performance Data Summary:

#### Summary of mechanical properties of proposed device to the product standard (BS EN ISO 6872:2015).

| Product | Flexural strength<br>[MPa] from standard<br>minimum value for<br>mean | Test Result | Product | Coefficient of Thermal<br>Expansion | Test Result<br>um/m-C° |
|----------------------------|-----------------------------------------------------------------------|-------------|----------------------------|-------------------------------------|------------------------|
| ArgenZ HT+ | 800 | 1348 | ArgenZ HT+ | 25-500°C | 10.3 |
| ArgenZ HT+ Shade (A4) | 800 | 1172 | Argen Pearl Brand Zirconia | 0-800°C | 9 |
| ArgenZ HT+ Shade (OM1) | 800 | 1143 | | | |
| Argen Pearl Brand Zirconia | 800 | 900 | | | |

#### Summary of chemical properties of the proposed device to the product standard (BS EN ISO 6872:2015)

| Product | Chemical solubility<br>[µg/cm²] | Test Result |
|------------------------|---------------------------------|-------------|
| ArgenZ HT+ | <100 | 66.11 |
| ArgenZ HT+ Shade (A4) | <100 | 3.10 |
| ArgenZ HT+ Shade (OM1) | <100 | 3.10 |

#### Predicate Device Comparison:

| ITEM | Subject Device<br>ArgenZ HT+ | Predicate Device<br>K180252 |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | EIH | EIH |
| Regulation<br>Number | 872.6660 | 872.6660 |
| Intended Use | ArgenZ HT+ (high translucent<br>plus) zirconia can be used for the<br>production of full contour and<br>substructure restorations up to a<br>full arch.<br>Note: The predicate device states<br>an intended use that is specific to<br>the manufactures business.<br>Both materials can be used for the<br>applications stated by the<br>predicate.<br>Both meet Class 5 mechanical and<br>chemical property requirements of<br>ISO 6872.<br>We recommend the<br>aforementioned Intended use. | Crown Dental Zirconia Blank & Crown<br>Dental Zirconia Pre-Shaded Blank are<br>indicated for the production of artificial<br>teeth in fixed or removable dentures,<br>or for jacket crowns, facings, and<br>veneers. |
| Feature | Shaded | Colored |
| Shape | Discs | Discs |
| Type and Class per<br>ISO 6872:<br>2015 | Type II Class 5 | Type II Class 5 |
| Sterility | Non-sterile | Non-sterile |
| Chemical<br>Composition<br>(Weight %) | ZrO2+HfO2+Y2O3 > 99 wt%<br>Inorganic Pigments < 1% | ZrO2>99.0%<br>Inorganic Pigment<br>(Al2O3, SiO2, Fe2O3, Er2O3) < 1% |
| Crystal<br>Morphology | Tetragonal | Tetragonal |
| Density | 6.08g/cm3 | 6.00g/cm3 |
| Sintering<br>temperature | 1500°C | 1500±50°C |
| Performance | Comply with ISO 6872 | Comply with ISO 6872 |
| Contact Level | surface device with permanent<br>contact (>30 days) | surface device with permanent contact<br>(>30 days) |
| Biocompatibility | Tested for Cytotoxicity on shaded<br>material, no adverse reactions<br>identified. | Tested for Cytotoxicity, irritation,<br>sensitization, accurate systematic<br>toxicity, genotoxicity, no adverse react<br>identified. |

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

#### Summary of the biological testing conducted on the device:

The device was evaluated for cytotoxicity based on ISO 10993-5 using the ISO Agarose Overlay Method.

Test Results/Summary:

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

The test article showed no evidence of causing cell lysis or toxicity. The test article met the requirements of the test.

### Conclusion:

The proposed and predicate devices are composed of a similar material makeup. All devices have similar indications for use.

The proposed and predicate devices have similar properties.

The performance results and technical characteristics support the findings of substantial equivalence.

We are claiming substantial equivalence of ArgenZ HT+ to the predicate device.

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

Image /page/4/Picture/0 description: The image shows the logo for "The Argen Corporation". The logo includes the company name, address, phone number, and fax number. The address is 5855 Oberlin Drive, San Diego, CA 92121-4718, United States of America. The phone number is [phone] and the fax number is [phone].

# Indications for Use Statement

Device Name: ArgenZ HT+

Indications for Use:

ArgenZ HT+ (high translucent plus) zirconia can be used for the production of full contour and substructures restorations up to a full arch.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __ (21 CFR 807 Subpart C)

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

Image /page/5/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 & Human Services logo. To the right of that is the FDA logo, which 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.

April 12, 2019

The Argen Corporation Craig Jolicoeur Quality & Regulatory Manager 5855 Oberlin Drive San Diego, California 92121

Re: K190079

Trade/Device Name: ArgenZ HT+ Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: December 12, 2018 Received: January 16, 2019

Dear Craig Jolicoeur:

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

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

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 (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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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