HyperFil-LV

{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 & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 14, 2018 Parkell, Inc. David Mott VP, Legal & Regulatory Affairs 300 Executive Drive Edgewood, New York 11717 Re: K182296 Trade/Device Name: HyperFil-LV Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: September 18, 2018 Received: September 20, 2018 Dear David Mott: 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/cdrl/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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ 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, Mary S. Digitally signed by Mary S. Runner -S3 Runner -S3 Date: 2018.12.14 20:03:41 -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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K182296 Device Name HyperFil®-LV Indications for Use (Describe) HyperFil®-LV is a dual-cure, tooth shade, resin composite which is indicated for Class I, II, III, IV, and V restorations, including root surface cavities, post cementing, and core build-ups. 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) # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {3}------------------------------------------------ ## 510(k) Summary #### 1. Submitter: Parkell, Inc. 300 Executive Drive Edgewood, NY 11717 #### 2. Submitter Parkell, Inc. 300 Executive Drive Edgewood, NY 11717 Phone: 631-389-1545 Fax: 631-389-1546 dmott@parkell.com Contact Person: David Mott, Vice President - Legal & Regulatory Date of Original Submission: August 23, 2018 Date of Latest Revision: December 13, 2018 #### 3. Type of Submission: Traditional 510(k). #### 4. Device | Device Proprietary Name: | HyperFil®-LV | |--------------------------|----------------------------| | Common or Usual Name: | Tooth shade resin material | | Classification Name: | Tooth shade resin material | | Regulation Number: | 21 CFR 872.3690 | | Product Code: | EBF | | Device Classification | II | #### 5. Primary Predicate Celerity (K062518, Parkell, Inc.) #### 6. Reference Device Composite Resin Core Material (K010475, Parkell, Inc.) (now marketed by Parkell under the trade name "Absolute Dentin®") #### 7. Device Description HyperFil®-LV is a dual-cure, highly radiopaque, flowable, bulk-fill composite restorative material suitable for direct and indirect restorations. HyperFil®-LV is light-curable to a depth of about 3-4 mm in 40 seconds with a dental curing light emitting at 430 - 480 nm with an intensity of >600 mW/cm². It will also self-cure to any depth in about 4-5 minutes at mouth temperature. HyperFil®-LV contains a combination of filling agents which give restorations constructed with HyperFil®-LV high compressive, tensile, and flexural strength. Image /page/3/Picture/17 description: The image displays the logo for "DirectaDentalGroup" in a large, white, sans-serif font. Below the main logo, there is a line and the text "STOCK SUMMARY". Underneath this, there are four smaller logos: "DIRECTA directa dental.com", "topdental", "ORSING", and "parkell". The background is a dark blue color. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "parkell" in a bold, sans-serif font. To the right of "parkell" is the word "inc." in a smaller, italicized font. The text is black and the background is white. HyperFil®-LV will be packaged in single dual-chamber 5 mL syringes. The device comprises catalyst and base components, which are combined just prior to use via a mixing tip which is affixed to the dual chamber syringe. ## 8. Indications for Use HyperFil®-LV is a dual-cure, tooth shade, resin composite which is indicated for Class I, III, IV, and V restorations, including root surface cavities, post cementing, and core build-ups. ## 9. Comparison of Technological Characteristics The standards applicable to the subject device and to the comparison of technological characteristics referenced within the submission, include: ADSI/ADA Specification No. 27: Resin-Based Filling Materials, ISO 4049:2009 Dentistry – Polymer Based Restorative Materials, ISO/TS 14569-1:1999 Dental Materials – Guidance on testing of wear resistance – Part 1: Wear by tooth brushing, and BS ISO 23317: 2014 Implants for Surgery – In vitro evaluation for apatite-forming ability of implant materials. Information provided in this 510(k) submission demonstrates that HyperFil®-LV is substantially equivalent to the Primary Predicate, Parkell's Celerity (K062518) (now marketed by Parkell under the trade name, HyperFil® dual-cure restorative composite) in terms of critical properties for restorative composites (e.g., compressive, tensile, and flexural strength), wherein HyperFil® LV differs from the Primary Predicate in that has a lower viscosity, making it more flowable than the Primary Predicate, and is bioactive as is demonstrated within this 510(k) submission. Any differences between the Device and the Primary Predicate, for purposes of this 510(k) submission, do not raise new questions of effectiveness or safety. Thus, this submission demonstrates the substantial equivalence of HyperFil®-LV to the Primary Predicate. A brief comparison of HyperFil®-LV to the Primary Predicate is provided in Table 5-A below. In addition, information has been included regarding a Reference Device (namely, "Composite Resin Core Material", K010475, Parkell, Inc., which is now marketed by Parkell under the trade name "Absolute Dentin®") in order to address any differences in water sorption and water solubility that may exist between the Device and Primary Predicate. | Property<br>(pass/fail criteria, if<br>applicable) | HyperFil®-LV<br>(Parkell, Inc.)<br>(K182296) | Primary Predicate<br>(Celerity)<br>(K062518, Parkell, Inc.) | |----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------| | Intended uses | A dual-cure, tooth shade, resin<br>composite which is indicated for<br>Class I, II, III, IV, and V restorations,<br>including root surface cavities, post<br>cementing, and core build-ups. | A dual-cure, tooth shade, resin<br>composite for the restoration of<br>Class I, II, III, IV, and V cavities in<br>permanent and deciduous teeth. | #### Table 5-A: {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "parkell" in bold, black letters. To the right of "parkell" and slightly below it, the word "inc." is written in a smaller font size. The font of the word "inc." is also more cursive than the font of the word "parkell." #### Table 5-A (continued): | | HyperFil®-LV | Primary Predicate | |------------------------------------|----------------------------------------------|--------------------------------------------------| | | (Parkell, Inc.)<br>(K182296) | (Celerity)<br>(K062518, Parkell, Inc.) | | Classification Product<br>Code | EBF | EBF | | Regulation Number | 21 CFR 872.3690 | 21 CFR 872.3690 | | Principle of operation | dual cured resin material | dual cured resin material | | Packaging | dual-barrel syringe (5mL) with<br>mixing tip | dual-barrel cartridge (10 mL) with<br>mixing tip | | Dual-cure | yes | yes | | Radiopaque | yes | yes | | Sterile | no | no | | Compressive Strength<br>(>300 MPa) | >300 MPa | >300 MPa | | Flexural Strength<br>(>100 MPa) | >100 MPa | >100 MPa | | Tensile Strength<br>(>40 MPa) | >40 MPa | >40 MPa | | Depth of Cure<br>(>1 mm) | >1 mm | >1 mm | | Modulus of Elasticity<br>(>10 GPa) | >10 GPa | >10 GPa | | Radiopacity (>200%) | >200% | >200% | | Water Sorption<br>(<40 µg/mm³) | <40 µg/mm³ | <40 µg/mm³ | | Water Solubility<br>(<7.5 µg/mm³) | <7.5 µg/mm³ | <7.5 µg/mm³ | | Chemical Components | EBPADMA | EBPADMA | | | TEGDMA | TEGDMA | | | UDMA | UDMA | | | 1,6-Hexanediol dimethacrylate | | | | | Tri-EDMA | | | Silica-barium Filler | Silica-barium Filler | As seen above, the differences between the Device and primary predicate are limited, e.g., to minor differences in chemical components and in packaging. These technological differences do not raise different questions of effectiveness or safety and are addressed by comparative performance data addressed within this submission. Minor differences also exist in the water solubility and water sorption values between the Device and Primary Predicate, though all values meet specifications defined for restoratives in ISO 4049:2009 and information is provided for the Reference Device which is directed to water solubility and sorption. In addition, minor differences exist in the indications-for-use language between the Device and primary predicate. Namely, the indications-for-use language for the Device identifies three common procedures {6}------------------------------------------------ (namely, root surfaces cavities, post cementing, and core build-ups) which are well known in the art to be encompassed or associated with Class I, II, III, IV, and V restorations (for which the primary predicate is cleared). As such, and for this reason, these differences do not impact the safety and effectiveness of the device. ## 10. Biocompatibility An evaluation of biocompatibility was conducted to determine the safety of HyperFil®-LV in accordance with ISO 10993-1: 2009, ISO 10993-5: 2009, ISO 10993-5: 2009, ISO 10993-11:2017, ISO 10993-12: 2012, and the Final FDA Guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (June 16, 2016). The conclusion of the evaluation is that HyperFil®-LV can be considered biocompatible. ## 11. Clinical Performance Data There was no clinical testing required to support the Device as the intended uses are equivalent to the Primary Predicate. These types of devices, including the Primary Predicate, have been on the market for many years with no reported adverse events. The non-clinical testing detailed in this submission supports the substantial equivalence of the Device. ## 12. Shelf Life An evaluation of the shelf life of the Device was conducted following real-time storage of the Device at room temperature, as well as after storage under accelerated aging conditions, via physical properties testing in accordance with ISO 4049:2009 Dentistry – Polymer Based Restorative Materials and ASTM D2583-95: Standard Test Method for Indentation Hardness of Rigid Plastics by Means of a Barcol Impressor. ## 13. Statement of Substantial Equivalence: The information provided above supports that HyperFil --LV is substantially equivalent to the primary predicate. Although minor differences in design and technology exist between the subject and primary predicate, the testing supports that these differences do not raise any new questions of effectiveness or safety. Therefore, it is concluded that HyperFil" -LV is substantially equivalent to the primary predicate.