CFS FLEXIBLE

{0}------------------------------------------------ K0815537 JAN 22 2009 # 510(k) Summary As Required by 21 section 807.92 ( c ) | 1-Submitter Name: | Angel L. Fernandez dba Comfort and Flexible Systems | |----------------------------|-----------------------------------------------------| | 2-Address: | 8223 Santa Fe Spring Road | | | Whittier, CA 90606 | | 3-Phone: | 562 693 3858 | | 4-Fax: | 562 745 5607 | | 5-Contact Person: | Mr Angel L Fernandez (President) | | 6-Date summary prepared: | May 16th, 2008 | | 7- Official Correspondent: | Mansour Consulting LLC | | 8- Address: | 845 Aronson Lake Court. Roswell, GA 30075 USA | | 9- Phone: | 678-908-8180 | | 10- Fax: | 678-623-3765 | | 11- Contact Person: | Jay Mansour, President | 12-Device Trade or Proprietary Name: CFS FLEXIBLE™ 13-Device Common or usual name: Denture Relining, Repairing, or Rebasing resin 14-Device Classification Name: Denture Relining, Repairing, or Rebasing resin 15-Substantial Equivalency is claimed against TCS® Unbreakable, cleared under K0530160 ### 16-Description of the Device: CFS FLEXIBLE™ is an injection moldable, flexible, thermoplastic nylon with trace amouni: of colorant added. CFS FLEXIBLE™ is used for fabricating removable dental prosthetic appliances such as in and partial dentures, orthodontics devices, occlusal splints and night guards both permanes and temporary. Because it can be used to create completely non-metallic prosthetics, 1 : perfect for making removable dental prosthetic @pliances for metal-allergic patients. ## 17 Intended use of the device: (refer to FDA form attached) CFS FLEXIBLE™ is a break resistant material used in the fabrication and repair of base plati for removable dental prosthetic appliances where superior flexibility and patient comfort for t lifetime of the prosthetic are significant concerns. This includes, but not limited to, full as partial dentures, orthodontic devices, occlusal splints, and night guards. ### 18-Safety and Effectiveness of the device: CFS FLEXIBLE™ is safe: and effective as the predicate device cited above. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The eagle is depicted in a simple, black and white design. The text is also in black and white and is written in all capital letters. Public Health Service JAN 2 2 2009 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Angel L Fernandez dba Comfort and Flexible Systems C/O Mr Jay Mansour President Mansour Consulting, L L C 845 Aronson Lake Court Roswell, Georgia 30075 Re K081537 > Trade/Device Name CFS FLEXIBLETM Regulation Number 21 CFR 872 3760 Regulation Name Denture Relining, Repairing, or Rebasing Resin Regulatory Class II Product Code EBI Dated December 8, 2008 Received January 21, 2009 Dear Mr Mansour We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantually 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 If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls Existing major regulations affectung 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 ... under in and the manus more to manages to com and contract and more of the comments of the comments of the comments of the comments of the comments of the comments of th ) {2}------------------------------------------------ Page 2 - Mr Mansour 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), 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 This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the DIVISIOn of Surveillance Systems at 240-276-3464 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 (240) 276-3150 or at its Internet address http //www fda gov/cdrh/industry/support/index html IPESA Fri TV LA SALES CONTRACT AND LA CART THE ART ART ART ART ART ART ART ART ART ART ART ART ART ART ART ART ART AND A CONSTITUTION CONSTITUTION CONSTITUTION CONSTITUTION Sincerely vours. Anthony V. Ansteen for Ginette Y Michaud, M D Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure ) {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) 50815337 Device Name CFS FLEXIBLE™ Indications For Use CFS FLEXIBLE™ is a break resistant material used in the fabrication and repar of base a CFS FLEXIBLE™ a a break resident material need in the rainment of the mortent combrition of the mort of the more plates for removed by and services where superor flexibility plates for removable dential prosthent concerns This includes, but not limited to, full for the lifetime of the prosthent are significant concerns This includes, but not l for the lifetime of the prosthetic are Significant Cornisher and partial dentures, orthodontic devices, occlusal splints, and night guards Prescription Use (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 Lievice Evaluation (ODE) Susan Rino (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number K081537 Page 1 of ____________________________________________________________________________________________________________________________________________________________________ PACI 14