(122 days)
No
The document describes a chemical solution for coloring dental prosthetics and does not mention any computational or data-driven processes indicative of AI/ML.
No
The device is described as an accessory for shading dental restorations and is not intended for the treatment, diagnosis, cure, or prevention of disease.
No
Explanation: The device is described as an "accessory for shading" dental restorations, specifically "aqueous solutions of transition and lanthanoid metal salts" used in combination with zirconia material "to properly shade teeth." It is used by trained dental technicians to modify the appearance of prosthetics and does not perform any diagnostic function such as identifying, detecting, or measuring a medical condition or disease.
No
The device description clearly states it is a dilute aqueous solution of metal salts, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to shade dental restorations, which are medical devices used in the body (or in the mouth, which is part of the body). IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The device is a coloring liquid applied to a dental material. It's not designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, providing diagnostic information, or being used in a laboratory setting for diagnostic purposes.
The device is clearly intended as an accessory for the fabrication of dental prosthetics, which are considered medical devices, but not IVDs.
N/A
Intended Use / Indications for Use
ArgenZ Liquids are intended to be used by trained dental technicians as an accessory for shading ArgenZ allzirconia, monolithic restorations for anterior and posterior dental prosthetics.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
ArqenZ Zirconia Coloring Liguids are dilute aqueous solutions of transition and lanthanoid metal salts used in combination with ArgenZ Zirconia material (K071410 and K150919) to properly shade teeth. Elements, which may include (but are not limited to) Co, Cr, Er, Fe, Mn, Pr, Ni, Bi, and Nd are combined with water to result in the finished product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior dental prosthetics
Indicated Patient Age Range
General, mostly adults
Intended User / Care Setting
trained dental technicians
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)
The device was evaluated for cytotoxicity based on ISO 10993-5 using the Minimal Essential Media (MEM) Elution Test. All test articles showed no evidence of causing any cell lysis or toxicity and met the requirements of the test since the grade was less than or equal to grade 2 (mild reactivity).
Summary of mechanical properties to the product standard (BS EN ISO 6872:2015):
ArgenZ HT+ Flexural strength: 1230 MPa
ArgenZ HT+ Shaded with ArgenZ HT Liquid (A4) Flexural strength: 1223 MPa
ArgenZ Anterior Flexural strength: 868 MPa
ArgenZ Anterior Shaded with ArgenZ ST Liquid (A3) Flexural strength: 765 MPa
ArgenZ Anterior Shaded with ArgenZ ST Liquid (C4) Flexural strength: 963 MPa
Summary of chemical properties to the product standard (BS EN ISO 6872:2015):
ArgenZ HT+ Chemical solubility: 4.16 μg/cm²
ArgenZ HT+ Shaded with ArgenZ HT Liquid (A4) Chemical solubility: 4.16 μg/cm²
ArgenZ Anterior Chemical solubility: 20.80 μg/cm²
ArgenZ Anterior Shaded with ArgenZ ST Liquid (A3) Chemical solubility: 10.32 μg/cm²
ArgenZ Anterior Shaded with ArgenZ ST Liquid (C4) Chemical solubility: 8.30 μg/cm²
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.
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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 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.
The Argen Corporation Craig Jolicoeur Quality & Regulatory Manager 5855 Oberlin Drive San Diego, California 92121
February 8, 2019
Re: K182833
Trade/Device Name: Argen Z Liquids (ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Pontic Reducer, and ArgenZ Color Modifier) Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: November 16, 2018 Received: November 16, 2018
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
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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 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.
Digitally signed by Mary S. Mary S. Runner -S3 Runner - S3 Date: 2019.02.08 10:01:37 -05'00'
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K182833
Device Name
ArgenZ Liquids (ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Pontic Reducer, and ArgenZ Color Modifier)
Indications for Use (Describe)
ArgenZ Liquids are intended to be used by trained dental technicians as an accessory for shading ArgenZ allzirconia, monolithic restorations for anterior and posterior dental prosthetics.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/4/Picture/8 description: This image is a document that appears to be a 510(k) Summary with the number K182833. It indicates that it was submitted by The Argen Corporation, located in San Diego, CA. The contact person is Craig Jolicoeur, and the date prepared is 9/28/2018. The trade names include ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, and ArgenZ Pontic Reducer, with a common name of ArgenZ Liquids, classification name of Porcelain powder for clinical use (21 CFR 872.6660), classification of Class II, and product code of EIH.
Legally marketed devices for which our organization is claiming substantial equivalence:
| 510(k)
| Number | Trade Name | Manufacturer |
|---|---|---|
| K111257 | HEISENBERG DYEING LIQUIDS | 3M ESPE AG |
Device Description:
ArqenZ Zirconia Coloring Liguids are dilute aqueous solutions of transition and lanthanoid metal salts used in combination with ArgenZ Zirconia material (K071410 and K150919) to properly shade teeth. Elements, which may include (but are not limited to) Co, Cr, Er, Fe, Mn, Pr, Ni, Bi, and Nd are combined with water to result in the finished product.
Intended Use:
ArgenZ Liguids are intended to be used by trained dental technicians as an accessory for shading ArgenZ frameworks and ArqenZ all-zirconia, monolithic restorations for anterior and posterior dental prosthetics.
Predicate devices: K111257
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Performance Data:
The raw materials and manufacturing process used in the fabrication of ArgenZ Liquids are similar to the materials and processes used in the industry to fabricate the predicate device. Section 18 contains test records of parent materials and representative accessories infused into the parent materials. The results demonstrate compliance with the product standard of the parent material.
Performance Data Summary:
Summary of mechanical properties to the product standard (BS EN ISO 6872:2015)
| Product | Flexural strength
[MPa] from standard
minimum value for | Test Result |
|---------------------------------------------------|---------------------------------------------------------------|-------------|
| | mean | |
| ArgenZ HT+ | 800 | 1230 |
| ArgenZ HT+ Shaded with ArgenZ HT Liquid (A4) | 800 | 1223 |
| ArgenZ Anterior | 500 | 868 |
| ArgenZ Anterior Shaded with ArgenZ ST Liquid (A3) | 500 | 765 |
| ArgenZ Anterior Shaded with ArgenZ ST Liquid (C4) | 500 | 963 |
Summary of chemical properties to the product standard (BS EN ISO 6872:2015)
| Product | Chemical solubility
[ug/cm²] | Test Result |
|---------------------------------------------------|---------------------------------|-------------|
| ArgenZ HT+ |