PROFIL COMPOSITES (PROFIL, PROFIL FLOW)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the word "SILMET" in bold, black letters. To the right of the word, there are three small, square images with a grainy texture. The first square is mostly white with some black speckles, the second is a mix of black and white, and the third is mostly black with some white speckles. The word "SILMET" is the most prominent feature of the image. #### 5. 510(k) Summary This summary of 510(k) safety and effectiveness is being submitted in accordance with requirements of 21 C.F.R. part 872.3690 Date prepared: January 24, 2011 #### Company | Name | Silmet Ltd | |-----------|-------------------------------------------------------------| | Address | 12 Hassadna St., Industrial Park<br>Or Yehuda 60200. Israel | | Telephone | 972 3 5331474 | | Fax | 972 3 5331581 | | Contact | Moshe Zalsman | | e-mail | moshe@silmet.co.il | FEB - 2 2011 FLA CDRIALAC Repaired - JAN 3 1 2011 #### Devices | Trade Name: | ProFil Composites (ProFil, ProFil Flow) | |----------------------|-----------------------------------------------| | Classification Name: | Tooth shade resin, material (21 CFR 872.3690) | | Common Name: | Dental Composites and Filling Materials | | Regulatory class: | Class II | #### Predicate Devices | GrandiO | (K051867, VOCO America) | |-------------------------------|------------------------------------| | Unifil Flow | (K020342, GC America) | | Filtek Supreme Ultra Flowable | (K100235, 3M ESPE Dental Products) | #### Description FENS, KIT - Pollusion (1981-149 SPORTED PORT PORTERS STORE STORE SERVER ASSEMBLE OF SEPT 1. The ProFil Composites are light cured restorative micro hybrid composite resins for use in both posterior and anterior restorations. The restoratives are available in a variety of tooth colored shades and are packaged in syringes and capsules. #### Device function, scientific concept, physical and performance characteristics ProFil Composites are a heterogeneous blend of organic filler. The proportion of these two components determines the physical properties of the restoration. The resin matrix contains bisphenol A glycidyl dimethacrylate( Bis-GMA) and triethylene glycol dimethacrylate (TEDGMA) is added to decrease the viscosity. The filler particles are silane-coated (for adhesion and coupling) barium silicate glass combined with 5 to 15 percent weight of very small-sized (0.04 micrometer) particles of colloidal silica. These Ight-cured composites include a photo-polymerizable synthetic organic resin matrix. A radiopaque oxide is added to make the composite fillings visible on radiographs. 11 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image contains the word "SILMET" in bold, black letters. To the right of the word are three squares with different textures. The first square has a light, speckled texture, the second square has a darker, more dense speckled texture, and the third square is almost completely black. # Device components Resin Matrix: BISGMA (bisphenol A-glycidyl methacrylate) and TEGDMA (Triethyleneglycol dimethacrylate) Filler particles: Silica filler Barium silicate glass combined with 5-15% weight of very small-sized (0.04 um) particles of colloidal silica. Filler type: Micro hybrid - the fillers are a mixture of different particle sizes all less than one micron (very fine colloidal silica particles, approx 0.04 microns). The extremely small filler particles lend superior polishability and allow for finer color characterization, while the composite, as a whole, remains about 70% -80% filled. The polymer materials are blended together with the finely divided inorganic material such as a barium aluminosilicate glass with a trace of radiopaque oxide that renders the resultant glass radiopaque to x-rays. Activation system: Light cured composites, photochemical initiation causes polymerization. The composites cure under halogen or LED lights (blue light)' # Indication for use | Products | Indications for Use | |-------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ProFil | Direct anterior & posterior restorations<br>Core Build ups<br>Splinting | | ProFil Flow | Class III, V & smaller Class IV restorations<br>Base/liner in Class I & Class II restorations<br>Repair resin, porcelain & acrylic temporary materials<br>Pit & fissure sealant<br>Undercut blockout<br>Restoration of minimally invasive cavity preparations | # Contraindications Patients with allergies to methacrylate monomers 1 See IFU curing time table 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the word "SILMET" in bold, black letters. To the right of the word, there are two squares filled with a grainy, speckled pattern. The pattern in the first square is lighter and more sparse, while the pattern in the second square is darker and more dense. # Table 1: Technological characteristics | Components | Function | | | | | | | | | | | | | |----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--------------------------------------------------------------------| | Fillers | | | | | | | | | | | | | | | Barium aluminosilicate<br>Fumed silica | Reduces thermal expansion coefficient and overall shrinkage. | | | | | | | | | | | | | | ProFil ProFil Flow Weight of filler: 78% 60% Volume of filler: 59% 42% Particle size 0.01-3µm 0.01-2.5µm | | | | | | | | | | | | | Improves handling and aesthetic results2<br>Provides radio-opacity | | Resin matrix | | | | | | | | | | | | | | | BIS-GMA (bisphenol glycidylmethacrylate) | These form highly cross linked polymer structures that results in a rigid resin matrix that is highly resistant to softening/degradation by heat and solvents. | | | | | | | | | | | | | | TEDGMA (Triethyleneglycol<br>dimethacrylate) | Diluent - Increases flow and handling characteristics or provide cross linking for improved strength | | | | | | | | | | | | | | Butylated hydroxytoluence | Stabilizer:Controls the reaction of activators and resin mixtures, added to avoid spontaneous polymerization<br>Extend storage lifetime<br>Ensure sufficient working time | | | | | | | | | | | | | | Camphoroquinone | Photochemical initiator: interact with the amine to form free radicals that initiate polymerization | | | | | | | | | | | | | # Summary of Physical Tests This 510(k) submission includes data from bench testing to evaluate the performance of the ProFil Composites compared to predicate devices GrandiO, Unifil Flow and Filtek Supreme Ultra Flowable. Properties evaluated include: Compressive Strength Flexural Strength Surface Hardness Water sorption Polymerization shrinkage Diametral Tensile Strength Flexural Modulus Radiopacity Water solubility ² The clinical choice of a composite must consider priority should be given to mechanical or aestheic requirements: if mechanical considerations are paramount the material with the greatest volume of fiesthetic considerations predominate, particle size will be the nost important factor. {3}------------------------------------------------ # Substantial Equivalence The information provided in this 510(k) submission shows that the ProFil Composites are substantially equivalent to: # GrandiO (K051867, VOCO America) Unifil Flow (K020342, GC America) Filtek Supreme Ultra Flowable (K100235, 3M ESPE Dental Products) The equivalence is in terms of intended use, indications for use, composition, physical properties and technological characteristics. A comparison of technological characteristics is provided below. | | | Table 2: Similarity of Technological properties to predicate devices | |--|--|----------------------------------------------------------------------| | | | | | Technological property | ProFil<br>Composites | GrandiO<br>(VOCO)<br>K051867 | UniFil Flow<br>(GC America)<br>K020342 | Filtek Supreme<br>Ultra Flowable<br>(3M ESPE)<br>K100235 | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|------------------------------|----------------------------------------|----------------------------------------------------------| | Camphorquinone/amine photoinitiator system | X | X | X | X | | Mehtacrylate-based resin matrix | X | X | X | X | | Silane treated fillers | X | X | X | X | | Bonded with a permanent dental adhesive | X | X | X | X | | When irradiated by light, the mehtacrylate<br>functionalities of the resins and surface<br>treated fillers undergo, in conjunction with<br>the photointitiator system, a light induced<br>polymerization to form a hard composite<br>that is bonded to the tooth structure with a<br>permanent dental adhesive | X | X | X | X | The prior use of all the components in the legally marketed predicate devices supports our decision that additional testing for bio-compatibility with the final formulation are not necessary. We believe that the prior use of these components in legally marketed devices and the performance data and results support the safety and effectiveness of ProFil Composites for the intended use. # Conclusion In accordance with 21 C.F.R. part 807 and FDA's " Guidance for the preparation of Premarket Notifications for Dental Composites" and based on the information provided in this premarket notification, Silmet Ltd. concludes that ProFil Composites are safe and effective and substantially equivalent to the predicate devices described herein. SILMET LTD. 24 January 2011 CEO: Moshe Zalsman Signature Image /page/3/Picture/17 description: This image shows a rectangular shape with the number '#2' written on the left side. To the right of the number is an oval shape with a star inside. There is a line that goes through the number and the oval shape. 12. Section of the consisted by the first ・・・・ 3 may be man and the became the contraction the titler canom and the subscription of the submit of the submit of the county of stress and the superior and sound to comments {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 or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609. Silver Spring, MD 20993-0002 Mr. Moshe Zalsman CEO SILMET Limited 12 Hasadna Or Yehuda ISRAEL 60200 FEB - 2 201 Re: K103190 Trade/Device Name: ProFil Composites (ProFil, ProFil Flow) Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin, Material Regulatory Class: II Product Code: EBF Dated: January 31, 2011 Received: January 31, 2011 Dear Mr. Zalsman: 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. Zalsman 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 yours, Wh for Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "SILMET" in bold, black letters. To the right of the word is a square that is divided into two smaller squares. The square on the left is lightly shaded, while the square on the right is more darkly shaded. 4. Indications for Use Statement 510(k) Number (if known): | (ס3196 Device Name: ProFil Composites (ProFil, ProFil Flow) | Products | Indications for Use | |-------------|-------------------------------------------------------| | ProFil | Direct anterior & posterior restorations | | | Core Build ups | | | Splinting | | ProFil Flow | Class III, V & smaller Class IV restorations | | | Base/liner in Class I & Class II restorations | | | Repair resin, porcelain & acrylic temporary materials | | | Pit & fissure sealant | | | Undercut blockout | | | Restoration of minimally invasive cavity preparations | Prescription Use _ V ("pri /i CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page of Susan Pinson (Division Sign-Off) (Division Sign-Off) Division of Anesthesiology, General Hospital Division of Anesthesiology, General Devices Division of Anesthesion 97. Infection Control, Dental Devices 510(k) Number: