Pulpdent Solo Flowable Composite with MCP

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black against a white background. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 1, 2016 PULPDENT CORPORATION c/o Roger Mastrony MedTek LLC. 2516 Kettle Creek Court Lincolnton, North Carolina 28092 Re: K153249 Trade/Device Name: Pulpdent Solo Flowable Composite with MCP Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth-shade resin material Regulatory Class: Class II Product Code: EBF Dated: March 25, 2016 Received: March 28, 2016 Dear Mr. Roger Mastrony: 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 {1}------------------------------------------------ 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 device-related 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. 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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. **Tejashri Purohit-Sheth, M.D.** Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH 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}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: Pulpdent Solo Flowable Composite with MCP Indications for Use: Pulpdent Solo Flowable Composite with MCP is a fluoride, calcium and phosphate-releasing flowable composite used by dental professionals as a restorative, base and liner. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) {3}------------------------------------------------ # PULPDENT CORPORATION 80 Oakland Street Watertown, MA 02472 USA ### 510(k) SUMMARY DATE OF SUBMISSION: April 1, 2016 OWNER: Pulpdent Corporation 80 Oakland Street Watertown, MA 02472 USA CONTACT: Roger S. Mastrony 2516 Kettle Creek Court Lincolnton NC 28092 Tel: 1 203 640 5047 Email: rogermastrony@gmail.com TYPE OF SUBMISSION: Traditional 510(k). #### DEVICE: Trade Name: Pulpdent Solo Flowable Composite with MCP Device Class: II Classification Name: Tooth-shade resin material FDA Product Code: EBF #### PREDICATE DEVICE: Pulpdent ACTIVA BioACTIVE-RESTORATIVE, K130223 (Pulpdent RMGI Fill) NOTE: Pulpdent RMGI Fill was the working name for ACTIVA BioACTIVE-RESTORATIVE that was used during the design and development of the product before a marketing name was decided upon. It is the same exact formula. #### REFERENCE DEVICE: Bosworth AEGIS V with ACP, K103585 #### DESCRIPTION: Pulpdent Solo Flowable Composite with MCP is a light-cured, radiopaque, glass-filled resin with MCP (modified calcium phosphate filler) that releases calcium and phosphate ions into the oral environment and which may be formulated to release fluoride ions. Solo Flowable Composite with MCP contains no Bisphenol A, no BisGMA and no BPA derivatives. It is available in tooth shades, has low solubility, low water sorption and high physical properties. #### INTENDED USE: Pulpdent Solo Flowable Composite with MCP is a fluoride, calcium and phosphate-releasing flowable composite used by dental professionals as a restorative, base and liner. {4}------------------------------------------------ 80 Oakland Street Watertown, MA 02472 USA # BIOCOMPATIBILITY EVALUATION: Pulpdent Solo Flowable Composite with MCP was tested with a Cytotoxicity Test (ISO 10993-5.2009) and an Implantation Test (ANSI/ADA Specification 41 and ISO 7405) and found to be biocompatible. ### COMPARISON WITH PREDICATE AND REFERENCE PRODUCTS: | | Pulpdent Solo Flowable<br>Composite<br>K153249 / EBF | Predicate Product:<br>Pulpdent ACTIVA BioACTIVE<br>RESTORATIVE (RMGI Fill)<br>K130223 / EMA | Reference Product:<br>Bosworth AEGIS V with ACP<br>K103585 / EBF, EMA | | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--| | DESCRIPTION /<br>TECHNOLOGY | Light-cured, glass-filled resin<br>with modified calcium<br>phosphate | Dual-cure, resin-modified glass ionomer<br>with ion releasing resins and glass | Light-cured, glass-filled resin<br>with amorphous calcium<br>phosphate | | | INTENDED USE | Dental restorative, base and<br>liner | Dental restorative* | Dental restorative and liner | | | COMPOSITION | Diurethane dimethacrylate<br>Bis (2-(Methacryloyloxy) Ethyl)<br>Phosphate<br>Barium glass<br>Strontium glass<br>Camphorquinone<br>Sodium fluoride (optional)<br>MCP (Modified calcium<br>phosphate)<br>Colorants | Diurethane dimethacrylate<br>Bis (2-(Methacryloyloxy) Ethyl)<br>Phosphate<br>Barium glass<br>lonomer glass<br>Polyacrylic acid/maleic acid copolymer<br>Dual-cure chemistry<br>Sodium fluoride<br>Colorants. | BisGMA (Bis [4-2 (hydroxy-3-<br>methacryloxy propyl) phenyl]<br>propane-2)<br>Barium glass<br>Camphorquinone<br>ACP (Amorphous Calcium<br>phosphate) | | | PHYSICAL PROPERTIES | | | | | | Light cure set time | 20 seconds | 20 seconds | 20 seconds | | | Depth of cure | 2.84 mm | 2.80 mm | | | | Appearance | Tooth-shade paste | Tooth-shade paste | Paste | | | Odor | Mild, characteristic | Mild, characteristic | Mild, characteristic | | | Specific gravity | 1.810 ± 0.03 g /ml | Part A: 1.580 ± 0.02 g/mL<br>Part B: 1.620 ± 0.02 g/mL | 1.46 g/ml | | | Flexural strength (MPa) | 129 ± 18.7 | 108.4 ± 14.7 | | | | Flexural modulus GPa | 8.0 | ---- | | | | Compressive strength<br>(MPa) | 330 ± 47.9 | 270 ± 14 | | | | Diametral tensile<br>strength | 46.5 MPa | 44.4 ± 2.7 | | | | | Pulpdent Solo Flowable<br>Composite<br>K153249 / EBF | Predicate Product:<br>Pulpdent ACTIVA BioACTIVE<br>RESTORATIVE (RMGI Fill)<br>K130223 / EMA | Reference Product:<br>Bosworth AEGIS V with ACP<br>K103585 / EBF, EMA | | | Polymerization<br>shrinkage | 2.1 % | 1.7 % | | | | Water absorption | 1.73% | 1.77% | | | | Water solubility | 0.09 % | 0.25 % | | | | Fluoride releasing | Yes (optional) | Yes | No | | | Calcium releasing | Yes | Yes | Yes | | | Phosphate releasing | Yes | Yes | Yes | | {5}------------------------------------------------ # PULPDENT CORPORATION 80 Oakland Street Watertown, MA 02472 USA * Note: Although the intended use of Solo Flowable and ACTIVA RESTORATIVE are not identical, in dentistry, products are often used for multiple purposes. The inclusion of the indications for use does not change the intended use of the device because placing a "base' is one step in the process of cavity restoration. The device is placed in the same location for the purpose of filling a dental cavity and restoring function. The difference between a 'base' and a 'restorative' is the amount of the device material used. ## Similarities Pulpdent Solo Flowable Composite, ACTIVA BioACTIVE-RESTORATIVE and Bosworth Aeqis V with ACP are all glass-filled resin composites that release ions into the oral environment. All the devices have the same basic structure, i.e., glass-filled resin. Solo Flowable Composite, ACTIVA BioACTIVE-RESTORATIVE and Bosworth Aegis V with ACP are all intended to be used as dental restoratives; Solo Flowable Composite and AEGIS may also be used as a base and/or liner under cavity restorations. Solo Flowable Composite, ACTIVA and AEGIS all release calcium and phosphate ions. Solo Flowable may be formulated to release fluoride ions like ACTIVA does. Solo Flowable Composite and ACTIVA contain the same monomers, i.e., diurethane dimethacrylate and Bis (2-(methacryloyloxy) ethyl) phosphate. Solo Flowable Composite and AEGIS are one-part light-cured materials. Solo Flowable Composite, ACTIVA and AEGIS all light cure in 20 seconds. The predicate and reference medical devices have been found substantially equivalent under the 510(k) Premarket Notification process as Class II Dental Devices under CFR 872.3690 and 872.3275. ## Differences Solo Flowable Composite and ACTIVA are formulated with urethane dimethacrylate and Bis(2-(Methacryloyloxy) Ethyl) Phosphate. Bosworth Aegis V with ACP is formulated with BisGMA (Bis [4-2 (hydroxy-3-methacryloxy propyl) phenyl] propane-2). The difference is not significant because both monomers have an established history of use in dental materials and no substantial history of adverse reactions. ACTIVA is a two-part, resin-modified glass ionomer composite that has three setting mechanisms: light cure, self-cure resin chemistry, and acid-base glass ionomer reaction. Solo Flowable Composite and AEGIS are one-part, light-cured materials. This difference in curing chemistry is not significant because they are both used extensively in dental composites, have no substantial history of adverse events, and give the dentists a choice of curing method based on the clinical situation. {6}------------------------------------------------ 80 Oakland Street Watertown, MA 02472 USA # Conclusion Taking into account the above similarities and differences, Pulpdent Solo Flowable Composite with MCP is substantially equivalent in design, composition, performance and intended use to ACTIVA BioACTIVE-RESTORATIVE and Bosworth Aegis V with ACP.