PACSEAL PIT & FISSURE SEALANT

{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 abstract symbol that resembles a stylized human figure or a bird in flight. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 9, 2015 Pac-Dent International, Inc. Ms. Wenying Zhu Materials Engineer 21038 Commerce Point Dr. Walnut, California 91789 Re: K141717 > Trade/Device Name: Pacseal Pit & Fissure Sealant Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and fissure sealant and conditioner Regulatory Class: Class II Product Code: EBC Dated: January 29, 2015 Received: February 6, 2015 Dear Ms. Zhu: 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. {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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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. Sincerely yours, Image /page/1/Picture/8 description: The image contains a signature and the name "Tina Kiang". The signature is complex and illegible. There is also a small "-s" below the name. 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}------------------------------------------------ Image /page/2/Picture/0 description: The image is a logo for PacDent International, Inc. The logo is set against an orange background. The words "PacDent" are in a bold, black font, with the "R" in a circle next to it, indicating a registered trademark. Below "PacDent" is the text "International, Inc." in a smaller font, and below that is the phrase "passion for excellence..." Pac-Dent International, Inc. 21038 Commerce Pointe Dr. Walnut = California = 91789 t: 909.839.0888 f: 909.839.0881 www.pac-dent.com Section III # Indications for Use Statement 510(k) Number (if known): K141717 Device Name: _ PacSeal™ Pit & Fissure Sealant Indications for Use: PacSeal™ Pit & Fissure Sealant is intended for use as: - Seal the pits and fissures in teeth Prescription Use OR Over-The-Counter Use {3}------------------------------------------------ Image /page/3/Picture/0 description: The image is a logo for PacDent International, Inc. The logo is set against an orange background. The words "PacDent" are in a bold, black font, with a white swoosh underneath. Below that, the words "International, Inc." are in a smaller, white font, and below that, the words "passion for excellence..." are in a smaller, orange font. #### Pac-Dent International, Inc. 21038 Commerce Pointe Dr. Walnut = California = 91789 t: 909.839.0888 f: 909.839.0881 www.pac-dent.com Section IV # 510(k) Summary Submitter: Pac-Dent International, Inc. 21038 Commerce Point Dr. Walnut, CA91789 Contact Person: Wenying Zhu Materials Engineer 909-839-0888 ext.111 Date Summary Prepared: June 2014 ### Device Name Trade Name: PacSeal™ Pit & Fissure Sealant Common Name: Pit and Fissure Sealant Device Classification: Class II Classification Product Code: EBC Classification Name: Pit and Fissure Sealant and Conditioner per 21 CFR 872.3765 #### Predicate Device 3MTM Clinpro™ Sealant (K992326) Prevent Seal (K122521) #### Description of Device PacSeal™ Pit & Fissure Sealant is a fluoride releasing, light-cured acrylate resin designed to fill and seal the pits and fissures of teeth. #### Indications for Use Seal the pits and fissures in teeth #### Summary of Biocompatibility Tests The biocompatibility of PacSeal™ Pit & Fissure Sealant was found to be substantially equivalent to the predicate based on a risk assessment and the identification of legally marketed predicate devices for all ingredients in the chemical composition. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for PacDent International, Inc. The logo is set against an orange background. The words "PacDent" are in a bold, black font, with a curved white line underneath. Below this, the words "International, Inc." are in a smaller, white font, and below that, the words "passion for excellence..." are in a smaller, orange font. # Pac-Dent International, Inc. 21038 Commerce Pointe Dr. Walnut = California = 91789 t: 909.839.0888 f: 909.839.0881 www.pac-dent.com ## Comparison of Technological Characteristics and Performance | Descriptive<br>Information | Subject Device | Predicate Device | Predicate Device | |-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | PacSeal™ Pit & Fissure Sealant | 3M™ Clinpro™ Sealant (K992326) | Prevent Seal (K122521) | | Indication for<br>Use | Seal the pits and fissures in teeth | Pit and fissure sealant | To fill and seal pit and<br>fissure depressions of<br>teeth to prevent cavities<br>Covering layer or "initial<br>layer" in the fabrication<br>of esthetically<br>demanding composite<br>restorations<br>For repairs of composite<br>restorations | | Composition of<br>Materials | TEGDMA<br>BISGMA<br>UDMA<br>Glass particle filler (0.18µm -1.0µm)<br>Photoinitiator | TEGDMA<br>BISGMA<br>Glass particle filler (0.1µm -5.0µm)<br>Photoinitiator | UDMA<br>TEGDMA<br>HEMA<br>Glass particle filler<br>Photoinitiator | | Physical<br>Properties and<br>FDA-Recognized<br>Standards | Depth of Cure- ISO 6874-2005<br>: complies<br>Compressive Strength: 181 MPa<br>Diametral Tensile Strength: subject<br>device is equivalent to the predicate<br>device<br>Film Thickness: subject device is<br>equivalent to the predicate device<br>Flexural Strength- ISO 4049-2009:<br>complies<br>Light Curing Time- ISO 6874-2005<br>: 30 sec<br>Shear Bond Strength to Etched<br>Enamel: subject device is equivalent<br>to the predicate device | Depth of Cure- ISO 6874-2005<br>: 1.86 mm<br>Compressive Strength: 210 MPa<br>Diametral Tensile Strength: 37<br>MPa<br>Film Thickness: 10µm<br>Flexural Strength- ISO 4049-2009:<br>110 MPa<br>Light Curing Time- ISO 6874-2005<br>: 30 sec<br>Shear Bond Strength to Etched<br>Enamel: 8.12 MPa | N/A | | Delivery system | 1.2 mL pre-filled syringe | 1.2 mL pre-filled syringe<br>6 mL bottle | 1.2 mL pre-filled syringe | Based on the above comparisons and performance test results, Pac-Dent concludes that the subject device is substantially equivalent in intended use, composition, delivery system and performance to the predicate device. Physical properties evaluated include depth of cure, {5}------------------------------------------------ Image /page/5/Picture/0 description: The image is a logo for PacDent International, Inc. The logo is set against an orange background. The words "PacDent" are in a bold, sans-serif font, with a curved line underneath. Below that, the words "International, Inc." are in a smaller font. The tagline "passion for excellence..." is at the bottom of the logo. Pac-Dent International, Inc. 21038 Commerce Pointe Dr. Walnut = California = 91789 t: 909.839.0888 f: 909.839.0881 www.pac-dent.com > compressive strength, diametral tensile strength, film thickness, flexural strength, light curing time and shear bond strength to etched enamel. ### Substantial Equivalence In summary, this submission demonstrates that PacSeal™ Pit & Fissure Sealant is substantially equivalent to the identified predicate products for its intended use.