PROLINK ADHESIVES (PROLINK, PROLINK SE)

{0}------------------------------------------------ ## KINO3 ### 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: February 8, 2011 ### Company | Name | Silmet Ltd | |-----------|----------------------------------| | Address | 12 Hassadna St., Industrial Park | | | Or Yehuda 60200. Israel | | Telephone | 972 3 5331474 | | Fax | 972 3 5331581 | | Contact | Moshe Zalsman | | e-mail | moshe@silmet.co.il | ### Devices | Trade Name: | ProLink adhesives (ProLink, ProLink SE) | |----------------------|---------------------------------------------| | Classification Name: | Resin Tooth Bonding Agent (21 CFR 872.3200) | | Common Name: | Dental Adhesives | | Regulatory class: | Class II | ### Predicate Devices | Adper Single Bond Plus | (K962785, 3M Dental Products) | |------------------------|---------------------------------| | iBond Total Etch | (K083652, Heraeus Kulzer, GmbH) | | G-Bond | (K041471, GC America) | | Clearfil Tri-S Bond | (K042913, Kuraray Medical Inc.) | ### Description - ProLink is a 50 generation dentin/enamel single step bonding agent. The primer and adhesive are . combined into a single component for ease of application. ProLink delivers outstanding shear bonding values to dentin, enamel & all popular light, dual or auto-cure composites. - ProLink SE is a 7th generation light cured self etching dentin/enamel bonding agent. The etch, primer . and adhesive are combined into a single component for ease of application. Separate conditioning (etching) of the enamel and dentine is not required. File No. 102010 Profink/SE 510k ~ FDA SUMET LTD. 12 Hassaha St. Indostral Park. Or Yehub 60201 html. Tel. +972 3 5331551 e-mail.nifo@silmadema.com www.simulesun.html 11 {1}------------------------------------------------ . . . . : # SILME ### Device function, scientific concept, physical and performance characteristics ProLink adhesives establish a bond to both the filling material and the dental hard tissue, i.e. enamel and dentin. There has been dramatic progression in the adhesion of dental adhesives and resins to enamel and dentin in the 40 years since Buonocore introduced the technique of etching enamel with phosphoric acid to improve adhesion to enamel. ### Device components and technological characteristic Similar to all other dental adhesives ProLink adhesives typically contain resin monomers, curing initiators, inhibitors or stabilizers, solvents and inorganic filler. The resin matrix functions as a backbone providing structural continuity and thus physical - mechanical properties such as strength. ### Function Components Fillers Filler particles modify the viscosity of the adhesive, offer Fumed silica higher elasticity ProLink SE ProLink 3% Weight of filler: 5.5 % 0.4 microns Size of filler: 6 microns Resin components Cross linkers that directly provide mechanical strength to Triethyleneglycol dimethacrylate adhesive system by forming densely cross linked polymers, (TEDGMA) helps prevent substantial water uptake after curing Urethandimethacrylate (UDMA) Its hydrophilicity makes it an excellent adhesion promoting 2-Hydroxyethylmethacrylate (HEMA) monomer Multifunctional dimethacrylates enhance wetting of dentin and thus improves bond strength Photo initiators: set off radical polymerization reaction of monomer Camphoroquinone Ethyl 4-dimethylaminobenzoate Solvents: promote good penetration of monomers in the collagen network of the demineralized dentin Ethanol & Acetone ### Table 1. Device Composition File No 82010 Profilfilow 510k - FDA ¹ Buonocore MG. A simple method of increasing the adhesion of acrylic filling materials to enamel surfaces. J Dent Res. 1955;34:849-853. {2}------------------------------------------------ ### Indications for use | ProLink | ProLink SE | |-------------------------------------------|-------------------------------------------------------------------------| | Direct Composite or Compomer restorations | Bonding of composites to tooth structure | | Adhesive cementation | Core Build up | | Composite repair | Adhesive cementation of crown & bridges, including inlays<br>and onlays | ### Contraindications Patients with a history of hypersensitivity to methacrylate monomers. Pulp capping ### Performance characteristics In addition to withstanding mechanical forces, and in particular shrinkage stress, the ProLink adhesives feature the following characteristics. - . high bond strength - a thin film thickness to ensure easy and complete seating of restorations . - . shelf stability - post placement stability. . {3}------------------------------------------------ Image /page/3/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 sections, one white and one black. The rest of the image is blurry and difficult to make out, but it appears to be more text. ### Summary of Physical Tests This 510(k) submission includes data from bench testing to evaluate the performance of the ProLink adhesives (ProLink, ProLink SE) compared to the following predicate devices: | Adper Single Bond Plus | (K962785) | |------------------------|-----------| | iBond Total Etch | (K083652) | | G-Bond | (K041471) | | Clearfil Tri-S Bond | (K042913) | Properties evaluated include: - 1. Shear Bond strength to etched enamel and to etched dentin - 2. Marginal integrity ### Substantial Equivalence Discussion The information provided in this 510(k) submission shows that the ProLink adhesives are substantially equivalent to: | Adper Single Bond Plus | (K962785, 3M Dental Products) | |------------------------|---------------------------------| | iBond Total Etch | (K083652, Heraeus Kulzer, GmbH) | | G-Bond | (K041471, GC America) | | Clearfil Tri-S Bond | (K042913, Kuraray Medical Inc.) | 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 | ProLink<br>Adhesives | Adper<br>Single<br>Bond<br>Plus | iBond<br>Total Etch | G-Bond | Clearfil<br>Tri-S<br>Bond | |-----------------------------------------------|----------------------|---------------------------------|---------------------|--------|---------------------------| | Camphorquinone/amine<br>photoinitiator system | X | X | X | X | X | | Methacrylate-based resin matrix | X | X | X | X | X | | Silane treated fillers | X | X | X | X | X | | Forms essential hybrid zone | X | X | X | X | X | | High Hydrophilicity | X | 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 ProLink adhesives 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 ProLink Adhesives are safe and effective and substantially equivalent to the predicate devices described herein. SILMET LTD. 8 February 2011 CEO: Moshe Zalsman Image /page/3/Picture/21 description: The image shows the word "Signature:" on the left side of the image. To the right of the word signature is a rectangular box with a star inside of an oval. There is a number 2 and some lines drawn on the box. . : File No. 82010 Profilfiew 510k - FDA 14 {4}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. Public Health Service 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 Hassadna Street Or Yehuda Isreal 60200 SEP - 8 2011 Re: K110403 Trade/Device Name: ProLink Adhesive (ProLink, ProLink SE) Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: September 4, 2011 Received: September 7, 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 ffor 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 (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 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.html 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 ### Enclosure {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 four smaller squares, with each square having a different pattern of black and white. To the right of the square is a series of blurry, illegible text. 4. Indications for Use Statement KI10403 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: ProLink adhesives (ProLink, ProLink SE) | Products | Indications for Use | |------------|--------------------------------------------------------------------------------------------------------------------------------------| | ProLink | Direct Composite or Compomer restorations<br>Adhesive cementation<br>Composite repair | | ProLink SE | Bonding of composites to tooth structure<br>Core Build up<br>Adhesive cementation of crown & bridges, including<br>inlays and onlays | Prescription Use __ V (Part 21 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 Ruon (Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K110403 File No. 82010 Profil/flow 510k - FIDA 10