JENSEN ZIRCONIA

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Jensen Dental. The logo consists of a stylized graphic to the left of the text "JENSEN" in large, bold, sans-serif font. Below the word "JENSEN" is the word "DENTAL" in a smaller, thinner, sans-serif font. The graphic to the left appears to be an abstract representation of a tooth or a dental-related symbol. Section E K112806 #### Submitted by: Jensen Industries 50 Stillman Road North Haven CT 06473 (203) 239-2090 phone (203) 234-7630 fax Contact: Gary Phelps Date Prepared: September 19, 2011 Device Name: Jensen Zirconia Common Name: Dental Ceramic Classification Name: Porcelain powder for clinical use (21 CFR 872,6660) Classification: Class II Product Code: EIH Predicate Devices Lava Frame: 510(k) number K011394 510(k) SUMMARY ### Device Description Jensen Zirconia ceramic is pressed and sintered blocks of Yttria stabilized Zirconia used to make copings and full contour crowns for dental restorations. Restorations are fabricated according to a dental impression scanned into a computing device. By CAD/CAM technology, the blocks are machined in an automated milling machine. After machining, the units are heat treated. Full contour units may then be stained and glazed with available finishing materials. Coping units can be completed by conventional veneering with available Zr compatible dental porcelains and stained and glazed. ## Indications for use Jensen Zirconia ceramic consists of pressed Zirconia Yttrium blocks for milling full contour crowns, crown and bridge substructures suitable for veneering to produce finished prostheses and implant superstructures for replacement of missing / damaged dentition ### Comparison to predicate device Data has been presented to demonstrate that the respective mechanical properties, chemical qualities, and the indications for use make Jensen Zirconia substantially equivalent to the predicate device LAVA Frame. The safety and effectiveness of Jensen Zirconia, being determined by the shared chemical qualities and mechanical properties, is therefore equivalent to the predicate device. (3) 50 Stillman Road, North Haven, CT 06473 JENSEN DENTAL {1}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element on the left and a stylized symbol on the right. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The symbol on the right features three curved shapes stacked on top of each other, resembling a stylized human figure or abstract design. #### Public Health Service Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Mr. Gary Phelps Quality Assurance Manager Jensen Industries, Inc. 50 Stillman Road North Haven, CT 06473 DEC - 1 2011 Re: K112806 Trade/Device Name: Jensen Zirconia Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: September 19, 2011 Received: September 28, 2011 Dear Mr. Phelps: 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. {2}------------------------------------------------ Page 2 - Mr. 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 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 vours. Anthony v. nuan 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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known): K | | 2806 Device Name: Jensen Zirconia Indications for Use: Jensen Zirconia consists of pressed Zirconia – Yttrium blocks intended for milling of full contour crowns, crown and bridge substructures and implant super structures to produce prostheses for replacement of missing / damaged dentition. Prescription Use X AND/OR (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) Susan Romer (Division Sign-Off) ് nvision of Anesthesiology, General Hospital Infection Control, Dental Devices 10(k) Number: K112806 Page 1 of 1 (2)