(86 days)
No
The summary describes a material (zirconia) used for dental restorations and focuses on its physical, chemical, and biological properties, with no mention of AI or ML.
No
The device is a material (zirconia) used for producing dental restorations, not a therapeutic device itself. Its therapeutic function is indirect, by enabling tooth restoration.
No
The device description indicates that ArgenZ HT+ zirconia is used for the "production of full contour and substructures restorations," which are dental prosthetics, not tools for diagnosing medical conditions.
No
The device description clearly states it is a physical material (pressed Yttria stabilized Zirconia) used for producing dental restorations, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the production of dental restorations (full contour and substructures). This is a medical device used in the body, not a device used outside the body to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the material composition of a dental material.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers
The information provided clearly describes a dental material used for creating prosthetics, which falls under the category of medical devices, but not IVDs.
N/A
Intended Use / 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.
Product codes
EIH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Summary of mechanical properties of proposed device to the product standard (BS EN ISO 6872:2015).
Product: ArgenZ HT+
Flexural Strength [MPa] from standard minimum value for mean: 800
Test Result: 1348
Coefficient of Thermal Expansion 25-500°C: 10.3 um/m-C°
Product: ArgenZ HT+ Shade (A4)
Flexural Strength [MPa] from standard minimum value for mean: 800
Test Result: 1172
Product: ArgenZ HT+ Shade (OM1)
Flexural Strength [MPa] from standard minimum value for mean: 800
Test Result: 1143
Product: Argen Pearl Brand Zirconia
Flexural Strength [MPa] from standard minimum value for mean: 800
Test Result: 900
Coefficient of Thermal Expansion 0-800°C: 9 um/m-C°
Summary of chemical properties of the proposed device to the product standard (BS EN ISO 6872:2015)
Product: ArgenZ HT+
Chemical solubility [µg/cm²]:
§ 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.
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: (858) 455-7900 and (858) 626-8686, respectively.
510(k) Summary K190079
| Submitted by: | The Argen Corporation
5855 Oberlin Drive, San Diego, CA 92121
(858) 455-7900 x471 (Phone), (858) 626-8655 (FAX) |
|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact person: | Craig Jolicoeur |
| Date prepared: | 3/26/2019 |
| Trade name:
Common name:
Classification name:
Classification:
Product Code: | ArgenZ HT+
ArgenZ
Porcelain powder for clinical use (21 CFR 872.6660)
Class II
EIH |
Legally marketed devices for which our organization is claiming substantial equivalence:
| 510(k)
| Number | Trade Name | Manufacturer | |
|---|---|---|---|
| K180252 | Primary | ||
| Predicate | |||
| Device | Crown Dental Zirconia Blank | ||
| & Crown Dental Zirconia Pre- | |||
| Shaded Blank | Crown Porcelain Dental Technology | ||
| Co., Ltd. | |||
| K071410 | Reference | ||
| 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
[MPa] from standard
minimum value for
mean | Test Result | Product | Coefficient of Thermal
Expansion | Test Result
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
[µg/cm²] | Test Result |
|------------------------|---------------------------------|-------------|
| ArgenZ HT+ | 99 wt%
Inorganic Pigments 99.0%
Inorganic Pigment
(Al2O3, SiO2, Fe2O3, Er2O3) 30 days) | surface device with permanent contact
(>30 days) |
| Biocompatibility | Tested for Cytotoxicity on shaded
material, no adverse reactions
identified. | Tested for Cytotoxicity, irritation,
sensitization, accurate systematic
toxicity, genotoxicity, no adverse react
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 (858) 455-7900 and the fax number is (858) 626-8686.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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