CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a black triangle on the left and the company name on the right. The company name is written in a bold, sans-serif font. . ## 005-510(k) Summary-807.92(c) This 510(k) summary is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92. . ### SUBMITTER INFORMATION A. | Company Name: | Prismatik Dentalcraft, Inc. | |-------------------------------|------------------------------------------------------------| | Company Address: | 2212 Dupont Dr., Suite IJK,<br>Irvine, CA 92612 | | Company Phone: | 949-225-1269 | | Company FAX: | 949-553-0924 | | Facility Registration Number: | 3005477956 | | Primary Contact Person: | Armin Zehtabchi, (949) 225-1234<br>Senior RA | | Secondary Contact Person | Marilyn Pourazar, (949) 225-1269<br>Senior Director, RA/QA | | Date Summary Prepared: | June 3, 2014 | ### DEVICE IDENTIFICATION B. | Trade/Proprietary Name: | Camouflage NanoHybrid Composite (Universal and<br>Flowable) | |-------------------------|-------------------------------------------------------------| | 21 CFR Reference: | 21 CFR 872.3690 | | 21 CFR Common Name: | Tooth shade resin material | | Classification: | Class II | | Product Code: | EBF | | Panel: | Dental | {1}------------------------------------------------ #### C. IDENTIFICATION OF PREDICATE DEVICE Trade/Proprietary Name: Composite 168 Restorative System (EsthetXHD/Flow) Dentsply-K973221 ### DEVICE DESCRIPTION D. The Camouflage Nanohybrid Composite (Universal and Flowable) is a light cured resin-based composite restorative. It is offered in High Viscosity ("Camouflage Universal" paste) and Low Viscosity (Camouflage Flowable), and is recommended for direct and indirect placement in all caries classes (both anterior and posterior restorations, including occlusal surfaces). It is available in multiple shades and opacities, and is radioopaque. It is composed of methacrylate monomers, Initiators, inhibitors, stabilizers, pigments, and inorganic fillers coated with a coupling agent. The Camouflage Nanohybrid Composite (Universal and Flowable) cures with light in the wavelength range of 400-500nm, and a dental adhesive is used to permanently bond the restoration to the tooth structure. ### INDICATIONS FOR USE E. The Camouflage NanoHybrid Composite (Universal and Flowable) are indicated for cavity classes I, II, III, IV, V, and VI in anterior and posterior teeth. · May be used as a direct restorative material · May be used for fabrication of inlays and onlays ## F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE PROPOSED DEVICE AND THE PREDICATE DEVICES Prismatik utilized the FDA's Guidance for Industry and FDA Staff - Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions for comparing its Camouflage NanoHybrid Composite (Universal and Flowable) with the Composite 168 Restorative System (EsthetXHD/Flow) Dentsply-K973221, The following comparison table of the technological characteristics of the proposed device and the predicate device outlines and provides the similarities and the substantial equivalency of the Camoutlage NanoHybrid Composite (Universal and Flowable) and the Composite 168 Restorative System (EsthetXHD/Flow) Dentsply-K973221. {2}------------------------------------------------ | | Predicate Device:<br>Composite 168<br>Restorative System<br>(EsthetXHD/Flow)<br>Dentsply<br>510(k)-K973221 | Proposed Device:<br>Camouflage Nanohybrid<br>Composite<br>(Universal and Flowable) | Similarities<br>and<br>Difference<br>Between the<br>Predicate and<br>the Subject<br>Device | |-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------| | Classification of<br>Polymer | Per ISO 4049<br>Type-1<br>Class-2<br>Group- 1&2<br>(Per ISO 4049) | Per ISO 4049<br>Type-1<br>Class-2<br>Group- 1&2<br>(Per ISO 4049) | Same | | Intended Uses Per<br>FDA Regulation | Intended to restore carious<br>lesions or structural defects<br>in teeth | Intended to restore carious<br>lesions or structural defects in<br>teeth | Same | | Indications for use<br>per 510k<br>Clearance Letter | • Indicated for cavity<br>classes I, II, III, IV, V, and<br>VI in anterior and posterior<br>teeth.<br>• May be used as a direct<br>restorative material<br>• May be used for<br>fabrication of inlays and<br>onlays | • Indicated for cavity classes I,<br>II, III, IV, V, and VI in<br>anterior and posterior teeth.<br>• May be used as a direct<br>restorative material<br>• May be used for fabrication<br>of inlays and onlays | Same | | FDA Description<br>and Product Code<br>Information | EBF<br>21 CFR 872.3690<br>Tooth shade resin material | EBF<br>21 CFR 872.3690<br>Tooth shade resin material | Same | | General Material | Tooth shade resin material | Tooth shade resin material | Same | | Delivery | • Syringes | • Syringes | Same | | Method(s) | • Capsules Tips | • Capsules Tips | Same | | Biocompatibility | Biocompatible | Biocompatible | Same | | Sterility | Non-Sterile | Non-Sterile | Same | | Single or Multiple<br>Use | Single Patient, multiple use | Single Patient, multiple use | Same | | Prescription/OCT<br>Use | Prescription | Prescription | Same | # Comparison of the Technological Characteristics of the Proposed and the Predicate Devices ### G. DETERMINATION OF SUBSTANTIAL EQUIVALENCE The above comparison table of the technological characteristics of the proposed device and the predicate devices was provided for the substantial equivalency of the Camouflage NanoHybrid Composite (Universal and Fiowable) and the Composite 168 Restorative System (EsthetXHD/Flow) Dentsply-K973221. Prismatik believes that the comparative {3}------------------------------------------------ data presented, demonstrate that the Camouflage NanoHybrid Composite (Universal and Flowable) is essentially the same as currently marketed devices for the same indications for use, and supports our claim of substantial equivalence to predicate Class II devices under the classification of 21 CFR 872.3690 that have previously been found to be substantially equivalent. Both the proposed and the predicate device consist of the same Product Code: EBF, which is biocompatible for the same indications for use. #### H. SUMMARY OF NON-CLINICAL TESTING Non-clinical test data was used to support the substantial equivalency. Specifically, the Camouflage Nanohybrid Composite (Universal and Flowable) was evaluated using the relevant FDA recognized standard: ISO 4049: 2009 Dentistry - Polymer-based restorative materials. In addition, Prismatik utilized the FDA's Guidance for Industry and FDA Staff - Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions. To provide evidence, assurance for the device safety and meeting the ISO 4049 requirements. Prismatik performed various testing including the Sensitivity to Ambient Light, Depth of Cure, Flexural Strength/Elastic Modulus, Water Absorption, Water Solubility, Shade Match/Shade Stability and Radio Opacity. ### CONCLUSION FROM THE NON-CLINICAL TESTING I. The results of the above described studies demonstrate that the Camouflage NanoHybrid Composite (Universal and Flowable) is substantially equivalent to the cleared predicate device, the Composite 168 Restorative System (EsthetXHD/Flow) Dentsply-K973221. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. ### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002 June 4, 2014 Prismatik Dentalcraft, Inc. C/O Mr. Armin Zehtabchi Senior Regulatory Analyst 2212 Dupont Drive, Suite IJK Irvine, CA 92612 Re: K133850 Trade/Device Name: Camouflage Nanohybrid Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade, resin Regulatory Class: Il Product Code: EBF Dated: April 29, 2014 Received: April 30, 2014 Dear Mr. Zehtabchi: 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. {5}------------------------------------------------ Page 2 - Mr. Zehtabchi 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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance 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. Sincerely vours. MarylSTByner-S Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangle on the left and the company name on the right. The triangle is filled with a dark color and has a textured appearance. The company name is written in a bold, sans-serif font. Page 12 of 186 ## 004-Indications for Use Statement 510(k) Number (if known): To be determined Camouflage Nanol lybrid Composite (Universal and Flowable) Device Name: Indications for Use: The Camouflage NanoHybrid Composite (Universal and Flowable) are indicated for cavity classes I, II, III, IV. V, and VI in anterior and posterior teeth. · May be used as a direct restorative material · May be used for fabrication of inlays and onlays | Prescription Use: | Yes <span> <div style="display:inline-block; border: 1px solid black; width:10px; height:10px;"> <span style="position:relative; left:0; top:-2px;"><b>X</b></span> </div> </span> No <span> <div style="display:inline-block; border: 1px solid black; width:10px; height:10px;"></div> </span> | |-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | (Part 21 CFR 801 Subpart D) | Over-the-Counter Use: Yes | No Z (Part 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) Sheena A. Green:=S 2014.06.03 14:52:53-04'00'