HAPI Seal

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an emblem featuring a stylized depiction of three human profiles. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 23, 2017 Bisco, Inc. Ryan Hobson Regulatory Affairs Product Registration Coordinator 1100 West Irving Park Rd. Schaumburg, Illinois 60193 Re: K162598 Trade/Device Name: HAPI Seal Regulation Number: 21 CFR 872.3765 Regulation Name: Pit And Fissure Sealant And Conditioner Regulatory Class: Class II Product Code: EBC Dated: May 23, 2017 Received: May 23, 2017 Dear Ryan Hobson: 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, 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 devicerelated 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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. Image /page/1/Picture/6 description: The image shows the signature of Mary S. Runner -S, followed by the signature of Tina Kiang, Ph.D. Above the signature of Mary S. Runner -S, the word "Sincerely" is written. To the right of the signature is a digital signature with the date 2017.05.23 12:25:35-04'00'. 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) K162598 Device Name HAPI Seal Indications for Use (Describe) Pit and fissure sealant Type of Use (Select one or both, as applicable) > 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." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for BISCO. The logo consists of five connected hexagons, alternating between red and blue. Below the hexagons is the word "BISCO" in a bold, sans-serif font, with the letters in gray and black. ## K162598 # 510(k) SUMMARY Bisco, Inc. 1100 W. Irving Park Road Schaumburg IL, 60193 Contact Person: Applicant: Ryan Hobson Tel: 847-534-6143 Fax: 847-534-6143 Date Prepared: 19 May 2017 Trade Name: Common Name: Product Code: Classification/Name: HAPI Seal Pit & Fissure Sealant ЕВС Pit and fissure sealant and conditioner Class II per 21 CFR 872.3765 ### Predicate Devices: HAPI Seal is substantially equivalent to: Clinpro by 3M Company, K992326 ### Indications for Use: Pit and fissure sealant ### Description of Applicant Device: HAPI Seal is a light-cured, fluoride containing, resin-based pit & fissure sealant designed for sealing the enamel pits and fissures of teeth. ### Comparison of Technological Characteristics: #### Indications for use HAPI Seal indications for use are identical to that of the predicate device and summarized in the table below: | Clinpro<br>K992326 | HAPI Seal | |-------------------------|-------------------------| | Pit and fissure sealant | Pit and fissure sealant | All components of HAPI Seal are based upon industry standard chemistry. The chemical composition of HAPI Seal is similar to Clinpro, methacrylate based chemistry, and is summarized in the table below: 800-247-3368 or 847-534-6000 Fax: 847-891-5049 www.bisco.com {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the text 'K162598' in a bold, sans-serif font. The text is arranged horizontally, with each character clearly legible. The color of the text is black, contrasting with the white background. Image /page/4/Picture/1 description: The image shows the BISCO company logo. The logo consists of a row of five connected hexagons, with the two outer hexagons being red and the middle hexagon being blue. The word "BISCO" is written in large, bold letters below the hexagons, with the letters being gray and black. # 510(k) SUMMARY (continued) | Chemical Composition | Clinpro | HAPI Seal | |-----------------------|--------------------|--------------------| | | K992326 | | | Filler | Silica | Silica | | Resin composition | Methacrylate Resin | Methacrylate Resin | | Polymerization Method | light cured | light cured | | lons Released | Fluoride | Fluoride | | Physical Mechanical Property | Clinpro<br>K992326 | HAPI Seal | |------------------------------|----------------------|----------------------| | Depth of Cure | Meets ISO 6874:2015 | Meets ISO 6874:2015 | | lons Released | Fluoride releasing | Fluoride releasing | | Polymerization time | 20 second light cure | 20 second light cure | | Bonding | Bonds to enamel | Bonds to enamel | #### Performance Data: HAPI Seal meets ISO 6874:2015 "Dentistry - Polymer-based pit and fissure sealants." Shear bond strength was tested based upon ISO 29022:2013 Dentistry - Adhesion - Notched-edge shear bond strength test. - Additionally, Light Curability, Ambient Light Sensitivity, Depth of Cure, Flexural Strength, Flexural Modulus, Cumulative Fluoride Release, Compressive Strength, Surface Hardness, and Shrinkage were tested and demonstrate HAPI Seal is substantially equivalent to the predicate device. A comparison of the physical/mechanical properties of HAPI Seal to the predicate device is provided in the table below. | Physical / Mechanical Property | HAPI Seal | |-----------------------------------------------------------|-----------------------------------------------------------------------------| | Shear Bond Strength<br>(Modified ISO 29022) | HAPI Seal is equivalent to the predicate. | | Light Curability (Cure time)<br>Ambient Light Sensitivity | HAPI Seal is equivalent to the predicate. | | Depth of Cure<br>(ISO 6874:2015) | HAPI Seal meets the requirements of ISO 6874:2015. | | Flexural Strength<br>(ISO 4049:2009) | HAPI Seal meets the requirements of ISO 4049:2009 for<br>Flexural Strength. | | Flexural Modulus<br>(ANSI/ADA Spec No. 27) | HAPI Seal is equivalent to the predicate | | Cumulative Fluoride Release | HAPI Seal is equivalent to the predicate. | | Compressive Strength<br>(ANSI/ADA Spec No. 27) | HAPI Seal is equivalent to the predicate. | | Surface Hardness<br>(Barcol-Colman 934-1) | HAPI Seal is equivalent to the predicate. | | Shrinkage (Volumetric) | HAPI Seal is equivalent to the predicate. | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the text 'K162598' in a bold, sans-serif font. The text is black against a light, slightly textured background. The numbers and letters are evenly spaced and clearly legible. Image /page/5/Picture/1 description: The image shows the logo for BISCO. The logo consists of a series of connected hexagons in red and blue. Below the hexagons is the word "BISCO" in large, bold, gray letters. # 510(k) SUMMARY (continued) ### Biocompatibility: An evaluation of biocompatibility was conducted using ISO 7405:2008 and ISO 10993-1 to determine the biocompatibility of HAPI Seal. Cytotoxicity and Oral Toxicity testing was completed. It is concluded from the biocompatibility evaluation and the results of Oral Toxicity Study (10 mice, 14 days) that HAPI Seal was not toxic in this test. ### Conclusion: It is concluded from review of the predicate device indications, chemical composition, biocompatibility, and physical properties that HAPI is substantially equivalent to the predicate devices. 800-247-3368 or 847-534-6000 Fax: 847-891-5049 www.bisco.com