P1145 Dental Restorative

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, stacked on top of each other, with flowing lines beneath them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 7, 2016 Kerr Corporation % Mohammad Ansari Regulatory Affairs Specialist Sybron Dental Specialties 1717 W. Collins Ave Orange, California 92867 Re: K162257 Trade/Device Name: P1145 Dental Restorative Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: August 5, 2016 Received: August 11, 2016 Dear Mohammad Ansari: 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ 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, Susan Russo, DDS, MA 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) (Not yet assigned) Device Name P1145 Dental Restorative ### Indications for Use (Describe) P 1145, a nanohybrid dental restorative, is indicated for direct placement in all cavity classes in anterior and posterior teeth. Additional indications include: repair of enamel defects, repair of provisionals, repair of porcelain restorations, minor occlusal build-ups, core build-ups and incisal abrasions. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Below the letters is the text "Sybron Dental Specialties" in a smaller, less bold, blue font. ## 510(k) SUMMARY for P1145 Dental Restorative In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided: - 1. Submitter Information: Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92867 | Contact Person: | Wendy Garman | |-------------------|--------------| | Telephone Number: | 909-962-5666 | | Fax Number: | 909-962-5694 | Date Prepared: November 7, 2016 - 2. Device Name: ● - Proprietary Name: P1145 Dental Restorative ● - Classification Name: Tooth Shade Resin Material - CFR Number: . - 872.3690 2 - Device Class: . Product Code: EBF . - 3. Predicate Device: The P1145 product line is substantially equivalent to the legally marketed device Herculite Ultra (K082671) cleared on December 11, 2008, product code EBF. #### 4. Description of Device: P1145 is a light-cured, esthetic, resin-based nanohybrid dental restorative designed for direct placement in both anterior and posterior restorations. It is designed to be used after placement of a dental adhesive. Once placed, the composite can be easily sculpted to the desired shape, and after curing, can easily be finished and polished to achieve a highly esthetic restoration. - న. Indications for Use: P1145, a nanohybrid dental restorative, is indicated for direct placement in all cavity classes in anterior and posterior teeth. Additional indications include: repair of enamel defects, repair of provisionals, repair of porcelain restorations, minor occlusal build-ups, core build-ups and incisal abrasions. {4}------------------------------------------------ #### Description of Safety and Substantial Equivalence: 6. ## Technological Characteristics The technological characteristics of P1145 are virtually identical to those of the predicate device, Herculite Ultra (K082671). Both formulas mostly contain solid filler-particles, mixed with a resin system, in order to form a high viscosity paste which can be directly applied into a restoration preparation. The filler systems in predicate Herculite Ultra (K082671) and P1145 are formulated in order to provide the composites its mechanical strength and durability, while maintaining excellent handling and esthetic characteristics. Additionally, the composites are formulated with methacrylate-based resin systems in combination with a photo-initiation system, which results in a polymerization of the composite when irradiated using a dental curing light. ## Non-Clinical Performance Data Non-clinical performance data included testing for mechanical strength (flexural strength, compressive strength, diametral tensile strength, Rockwell hardness), polishability, water sorption and solubility, depth of cure, light sensitivity, radiopacity, volumetric shrinkage, and color stability. Working time and gloss were also performed. The data analyzed from the various tests substantiate that P1145 is safe and effective as the predicate Herculite Ultra (K082671). The following standards were utilized for non-clinical performance testing of P1145: - . Guidance for Industry and FDA Staff: Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions, November 27, 1998 - ISO 10993-1: 2009 Biological evaluation of medical devices - . ISO 10993-3:2003 Biological Evaluation of Medical Devices- Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity - . ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for in Vitro Cytotoxicity - . ISO 10993-6:2007 Biological Evaluation of Medical Devices- Part 6: Tests for Local Effects after Implantation - . ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization - . ISO 10993-11:2011 Biological Evaluation of Medical Devices- Part 11: Tests for Systemic Toxicity - . ISO 14971:2007 Risk Management - . ISO 4049:2009 Dentistry- Polymer based Filling, Restorative, and Luting Materials. {5}------------------------------------------------ | Element | Predicate | Proposed | |-------------------------------|---------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Herculite Ultra | P1145 | | 510(k) | K121824 | To be assigned | | Trade Name | Herculite Ultra | P1145 | | Target Users | Licensed dental professionals | Licensed dental professionals | | Device Description | Herculite Ultra is a light-<br>cured, esthetic, resin-based<br>dental restorative. | P1145 is a light-cured, esthetic, resin-<br>based nanohybrid dental restorative<br>designed for direct placement in both<br>anterior and posterior restorations. It is<br>designed to be used after placement of<br>a dental adhesive. Once placed, the<br>composite can be easily sculpted to the<br>desired shape, and after curing, can<br>easily be finished and polished to<br>achieve a highly esthetic restoration. | | Intended Use | Dental Restorative | Dental Restorative | | Common Name | Dental Composite Restorative<br>Material | Dental Composite Restorative Material | | Classification Name | Tooth Shade Resin Material | Tooth Shade Resin Material | | Class | 2 | 2 | | Product Code | EBF | EBF | | Storage | Store at room temperature. | Store at room temperature. | | Indications for Use | Herculite Ultra is a dental<br>composite restorative material<br>intended to be used in all<br>classes of cavities. | P1145, a nanohybrid dental restorative,<br>is indicated for direct placement in all<br>cavity classes in anterior and posterior<br>teeth. Additional indications include:<br>repair of enamel defects, repair of<br>provisionals, repair of porcelain<br>restorations, minor occlusal build-ups,<br>core build-ups and incisal abrasions. | | Curing Mechanism | Photo-initiation | Photo-initiation | | Material<br>Compatibility | Meets Biocompatibility<br>Requirements | Meets Biocompatibility Requirements | | Shelf Life | Minimum 36 months based on<br>real time data | Minimum 24 months based on<br>accelerated data | | Particle Size<br>Distribution | Nanohybrid:<br>Proprietary formulation of<br>nano and non-nano particle<br>sizes of filler | Nanohybrid:<br>Same | # Table 5.1: Predicate and Proposed Device Comparison Table {6}------------------------------------------------ ## Clinical Performance Data Clinical performance testing has not been performed for P1145. Conclusion as to Substantial Equivalence The technological characteristics of P1145 are virtually identical to the predicate Herculite Ultra (K082671). These proposed P1145 has similarities in select performance characteristics as compared to the predicate. The proposed P1145 is substantially equivalent to the predicate Herculite Ultra (K082671) based on the similarities in the two products in design, device performance, biocompatibility testing, and the same intended use. The proposed product P1145 and Herculite Ultra (K082671) have the same intended use and are to be used in dental restorative procedures. The proposed device P1145 has more specific indications, as compared to Herculite Ultra (K082671), to clearly define and describe the device applications and types of restorative procedures as well as describe the nanohybrid filler composition. Any noted differences in technological characteristics between the proposed and predicate products do not raise new questions of safety and effectiveness and demonstrate the proposed product is at least as safe and effective as the legally marketed predicate device. Both Herculite Ultra (K082671) and P1145 utilize a nanohybrid filler system and a similar methacrylate-based resin system to achieve the same function. Herculite Ultra (K082671) and P1145. Based on this reasoning and the results of ISO 4049:2009 performance testing, including mechanical strength, depth of cure, shrinkage, polishability, color stability, and biocompatibility testing, P1145 is substantially equivalent to the predicate Herculite Ultra (K082671).