(98 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of the zirconia blanks, with no mention of AI or ML technology.
No
This device is a material used in the fabrication of dental prosthetics (inlays, crowns, copings, and fixed bridges). It is not itself a therapeutic device that directly treats or prevents a disease or condition.
No
This device is a material for fabricating dental restorations (inlays, crowns, copings, and fixed bridges) and does not perform any diagnostic function.
No
The device description clearly states it is a physical material (pressed Yttria stabilized Zirconia with oxides of Hafnium and Aluminum and an organic binder) used in the fabrication of 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 fabrication of dental restorations (inlays, crowns, copings, and fixed bridges). This is a manufacturing process for a medical device that will be placed in the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a material (zirconia) used in the fabrication process. It's not a reagent, instrument, or system designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnosing diseases, or providing information about a patient's health status based on in vitro testing.
The device is a material used in the creation of a dental prosthesis, which is a medical device, but the material itself is not an IVD.
N/A
Intended Use / Indications for Use
ArgenZ Esthetic Plus blanks are intended to be used in the fabrication of inlays, crowns, copings, and fixed bridges (up to 3 units) using various CAD/CAM systems.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
ArgenZ Esthetic Plus is a pressed Yttria stabilized Zirconia with oxides of Hafnium and Aluminum and an organic binder.
ArgenZ Esthetic Plus satisfies requirements for Class 5 (type II) ceramics when tested according to ISO 6872:2008.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of the physical testing conducted on the device: The materials are identical to the predicate device and hence have the same physical properties. The properties satisfy requirements for a Class 5 (type II) ceramic when tested in accordance with ISO 6872:2008.
Summary of the non-clinical testing: Non-clinical test data was used to support the claim of substantial equivalency. The flexural strength, fracture toughness, hardness, and translucency ensure conformance of ArgenZ Esthetic Plus to the input requirements and the flexural strength requirements of ISO 6872:2008.
Summary of the biological testing conducted on the device: The materials (Yttrium-stabilized Zirconia) used to produce ArgenZ Esthetic Plus have been studied extensively in medical applications. This type of material is the standard used for most all ceramic dental restorations in the world. Since the material used to produce the blanks is identical to the material used to produce the predicate device (see table on previous page), it follows that the proposed product is biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 13, 2015
The Argen Corporation Mr. Craig Jolicoeur Quality & Regulatory Manager 5855 Oberlin Drive San Diego, CA 92121-4718
Re: K150919
Trade/Device Name: ArgenZ Esthetic Plus Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Codes: EIH Dated: March 27, 2015 Received: April 17, 2015
Dear Mr. 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. The general controls provisions of the Act include requirements for annual registration. Isting 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.
1
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours. lina Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
510(k) Number (if known): K150919
Device Name: ArgenZ Esthetic Plus
Indications For Use: ArgenZ Esthetic Plus blanks are intended to be used in the fabrication of inlays, crowns, copings, and fixed bridges (up to 3 units) using various CAD/CAM systems.
Prescription Use X
(Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
3
Image /page/3/Picture/0 description: The image shows the logo and contact information for The Argen Corporation. The logo features a stylized letter "A" with the word "ARGEN" in bold letters. Below the logo is the company name, address (5855 Oberlin Drive, San Diego, CA 92121-4718, United States of America), telephone number (858-455-7900), and fax number (858-626-8686).
510(k) Summary
| Submitted by: | The Argen Corporation
5855 Oberlin Drive, San Diego, CA 92121
(858) 455-7900 x471 (PHONE), (858) 626-8686 (FAX) |
|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact person: | Craig Jolicoeur |
| Date prepared: | 3/27/2015 |
| Trade name:
Common name:
Classification name:
Classification:
Product Code: | ArgenZ Esthetic Plus
Dental Ceramic
Porcelain powder for clinical use (21 CFR 872.6660)
Class II
FIH |
Legally marketed device for which our organization is claiming substantial equivalence:
| 510(k)
| Number | Trade Name | Manufacturer |
|---|---|---|
| K143330 | BruxZir Anterior | PRISMATIK DENTALCRAFT, INC. |
Device Description:
ArgenZ Esthetic Plus is a pressed Yttria stabilized Zirconia with oxides of Hafnium and Aluminum and an organic binder.
ArgenZ Esthetic Plus satisfies requirements for Class 5 (type II) ceramics when tested according to ISO 6872:2008.
Intended Use:
ArgenZ Esthetic Plus blanks are intended to be used in the fabrication of inlays, crowns, copings, and fixed bridges (up to 3 units) using various CAD/CAM systems.
Predicate device: K143330
4
Summary of the physical testing conducted on the device:
The materials are identical to the predicate device and hence have the same physical properties. The properties satisfy requirements for a Class 5 (type II) ceramic when tested in accordance with ISO 6872:2008. A comparison to the predicate device is below:
| Predicate Devices | Proposed Device | |
|---|---|---|
| BruxZirTM Anterior (K143330) | Argen Z Esthetic Plus | |
| Classification of Ceramic | Type II, Class 6 | Same |
| Shapes/Sizes | Standard, R, Z, Type, DD, ZZ, ZZ Notch | 100/98/95mm Dia x |
| 10/14/18/22/25mm High | ||
| Material | Tosoh Powder | Same |
| Flexural Strength | Meets requirements, per ISO 6872 | >600 MPa Mean Value |
| Coefficient of Thermal | ||
| Expansion (CTE) / | ||
| (25-500 °C) | 11 X 10-6/K | Same |
| Density | 6.05 g/cm3 | Same |
| Biocompatibility | Biocompatible | Same |
| Indications for Use | The device is indicated for use by dental | |
| technicians in the construction of custom | ||
| made all ceramic restorations for anterior | ||
| and posterior location. | ArgenZ Esthetic Plus blanks are | |
| intended to be used in the | ||
| fabrication of inlays, crowns, | ||
| copings, and fixed bridges (up | ||
| to 3 units) using various | ||
| CAD/CAM systems. |
| Comparison between Predicate and Proposed Device | ||
|---|---|---|
We can conclude that ArgenZ Esthetic Plus have comparable technical characteristics and Indications for Use to the predicate device.
Summary of the non-clinical testing:
Non-clinical test data was used to support the claim of substantial equivalency. The flexural strength, fracture toughness, hardness, and translucency ensure conformance of ArgenZ Esthetic Plus to the input requirements and the flexural strength requirements of ISO 6872:2008.
Conclusion from the non-clinical testing:
The proposed device, ArgenZ Esthetic Plus, is the same material as the predicate device. It has the same performance specifications and intended use as the predicate device - BruxZir Anterior (K143330). There are no changes to the device, so no additional risks are present to the safety and efficacy.
Since the device is made from the same material, and has the same intended use as the predicate device. A conclusion can be drawn that the proposed device is substantially equivalent to the predicate device.
5
Summary of the biological testing conducted on the device:
The materials (Yttrium-stabilized Zirconia) used to produce ArgenZ Esthetic Plus have been studied extensively in medical applications. This type of material is the standard used for most all ceramic dental restorations in the world.
Since the material used to produce the blanks is identical to the material used to produce the predicate device (see table on previous page), it follows that the proposed product is biocompatible.
Substantial equivalence/Conclusion:
The proposed and predicate device is composed of a pressed Yttria stabilized Zirconia with oxides of Hafnium and Aluminum and an organic binder.
Both the proposed and predicate devices have identical compositions. Also, the physical and biological properties of the predicate and proposed devices are the same. In addition, both have the same intended use. ArgenZ Esthetic Plus is substantially equivalent in safety and effectiveness to the predicate device.
We are claiming substantial equivalence of the ArgenZ Esthetic Plus to the predicate device.