ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ #### 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) {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ 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)<br>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 {5}------------------------------------------------ # 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<br>[MPa] from standard<br>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<br>[ug/cm²] | Test Result | |---------------------------------------------------|---------------------------------|-------------| | ArgenZ HT+ | <100 | 4.16 | | ArgenZ HT+ Shaded with ArgenZ HT Liquid (A4) | <100 | 4.16 | | ArgenZ Anterior | <100 | 20.80 | | ArgenZ Anterior Shaded with ArgenZ ST Liquid (A3) | <100 | 10.32 | | ArgenZ Anterior Shaded with ArgenZ ST Liquid (C4) | <100 | 8.30 | # Predicate Device Comparison (Liquid): | | ArgenZ Liquids | HEISENBERG DYEING LIQUIDS | |----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------| | Properties and Information | | | | 510(k) | N/A | K111257 | | Indications for Use | ArgenZ Liquids are intended to be<br>used by trained dental technicians as<br>an accessory for shading ArgenZ<br>frameworks and ArgenZ all-zirconia,<br>monolithic restorations for anterior and<br>posterior dental prosthetics. | Liquid ceramic aid for complete or<br>partial coloring of all zirconium<br>oxide blanks intended to be used<br>for all ceramic dental restorations | | Prescription Use | Prescription Only | Prescription Only | | Target Population | General, mostly adults | General, mostly adults | | Type of Packaging | Liquid container | Liquid container | | Method of Manufacturer | Batch, at VITA shade | Batch, at VITA shade | | Packaging Volume (mL) | 30 and 100 | 100 and 250 | | VITA Shade | 16 | 16 | | Items in Product Line | ~ 90 | ~50 | | Storage Conditions | 2 years @ 25-75°C | 3-4 years at 4-10°C | | General Physical Form | Liquid | Liquid | | Specific Physical Form | Liquid | Liquid | {6}------------------------------------------------ | Odor | Characteristic odor | Characteristic odor | |---------------------|---------------------|---------------------| | Color | Yellow/orange | Yellow/orange | | pH | 6.5-7.5 | 6.5-7.5 | | Boiling Point | 100°C | 100°C | | Specific Gravity | 1.0-1.10 g/cm^3 | 1.00-1.10 g/cm^3 | | Solubility in Water | 100% | 100% | | Sterility | Non-sterile | Non-sterile | #### Summary of the biological testing conducted on the device: The device was evaluated for cytotoxicity based on ISO 10993-5 (Section 8.2) using the Minimal Essential Media (MEM) Elution Test. According to the criteria described in Table 1 (Section 8.5), a reactivity grade of greater than 2 (mild reactivity) is considered a cytotoxic effect. #### Test Requirements & Rationale for Cytotoxicity Test articles for the cytotoxicity testing were selected as representative samples for each product family, and determined to be worst case scenarios for potential biocompatibility issues. Specified zirconia materials will be used as a medium for testing the products. Table 1, shows the rationale used to determine which sample set would represent the entire product category. Since direct testing using the overlay method will be employed to determine cytotoxicity of the samples, indirect testing will not be necessary. | Liquids | Shade | Elements Present | Rationale | |------------------|-------|------------------|----------------------------------------| | Type | | | | | ST on<br>K150919 | A3 | Er Fe Ni | Highest Er | | ST on<br>K150919 | C4 | Mn Fe Ni | Mn presence, highest<br>presence of Ni | | HT on<br>K071410 | A4 | Cr Fe | Highest concentration<br>of elements | | HT on<br>K071410 | B4 | Pr Fe Cr | Pr presence, Cr<br>presence | Table 1: Rationale for liquid sample selection All tests articles showed no evidence of causing any cell lysis or toxicity. All test articles met the requirements of the test since the grade was less than or equal to grade 2 (mild reactivity). Complete test reports are available in Section 15 of this submission. Conclusion: Due to the lack of response, the products are considered biocompatible and substantially equivalent to the predicate devices. In addition, strong evidence supporting biocompatibility of the material can be seen when comparing chemical solubility results from the white and shaded materials. {7}------------------------------------------------ # 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 the ArgenZ Liquids to the predicate device.