THE LF-P CERAMIC SYSTEM

{0}------------------------------------------------ MAY - 4 2005 ## Section E ## 510(k) SUMMARY Jensen Industries Submitted by: 50 Stillman Road North Haven CT 06473 (203) 239-2090 phone (203) 234-7630 fax Contact: Gary Phelps Date Prepared: March 3, 2005 The LF-P Ceramic System Device Name: Dental Porcelain Common Name: Classification: Class II Product Code: EIH Predicate Devices: Ceramco Finesse All Ceramic (K971869) Willi Geller Creation & LF (K002904) Device Description The LF-P Ceramic System is a ceramic material formed into pellets intended for pressing into full contour restorations (crowns, onlays, inlays and veneers) and substructures as well as pressing to conventional precious and non-precious metal substructures. The system also includes low fusion ceramics suitable for layering or stain / glaze finishing. Data has been presented to demonstrate that the mechanical properties, chemical qualities, and the indications for use make the LF-P Ceramic System substantially equivalent to the predicate devices Ceramco Finesse All Ceramic and Willi Geller Creation & LF. The safety and effectiveness of the LF-P Ceramic System, being determined by the chemical qualities, cytotoxicity test results and mechanical properties, is therefore equivalent to the predicate devices. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a circular seal or logo. The seal contains the symbol of the Department of Health and Human Services (HHS) in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY - 4 2005 Mr. Gary Phelps Quality Assurance Manager Jensen Industries, Incorporated 50 Stillman Road North Haven, Connecticut 06473 Re: K050838 Trade/Device Name: The LF-P Ceramic System Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: March 30, 2005 Received: April 06, 2005 Dear Mr. Phelps: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your books on (1) }) }) }) } }) } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the enotoure) to regist 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 have been receitive in accordination of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, manker the device, babyev we an emirements for annual registration, listing of devices, good controlly provisions of the 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 If your device to such additional controls. Existing major regulations affecting your device can be may of subject to ston additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {2}------------------------------------------------ ## Page 2 - Mr. Gary Phelps 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 that 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 laboring (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) rms letet notification. The FDA finding of substantial equivalence of your device to a legally prematics notification - 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 if you don't the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Owes Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosures {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known): Device Name: The LF-P Ceramic System Indications for Use: the LF-P Ceramic System is a ceramic material formed into pellets Indications for Use: the Lr-F Cerumic Systems onlays, inlays and veners) and intended for pressing into till conventional precious and non-precious metal substructures. substructures as well as pressing to conventional precious artin's laze finishing. substructures as well as pressing to conventional precious and not p The system also includes low fusion ceramics suitable for layering or stain / glaze finishing. AND/OR Prescription Use _X_ (Part 21 CFR 801 Subpart D) 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 Device Evaluation (ODE) Kein Mulvey for NSR Sign-Off) I ivision of Anesthesiology, General Hospital, Intection Control, Dental Devices :(k) Number. K050838 Page 1 of (Ref: DCF 3419)