IBOND NEXT GENERATION

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings. JUN 7 - 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Cheryl V. Zimmerman Director, Quality Operations and Compliance Heraeus Kulzer, Incorporated 4315 South Lafayette Boulevard South Bend, Indiana 46614 Re: K051006 R051000 Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: April 15, 2005 Received: May 10, 2005 Dear Ms. Zimmerman: We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) premaited is substantially equivalent (for the indications for referenced above and nave determined the devices marketed in interstate comments on merce use stated in the enclosure) to legally market a lieving Amarketed in the devices th use stated in the enclosure) to legally manked Device Amendments, or to devices that prior to May 28, 1976, the enactified with the provisions of the Featural Food, Drug, and Cosmetic have been reclassified in accordance with the provisions of the Featuration have been reclassified in accordance with the provisions wal application (PMA). You may, Act (Act) that do not require approval of a premarket approval application of the ge Act (Act) that do not require approval of a premainco apovisions of the Act. The general therefore, market the device, subject to mir general son al registration, listing of devices, good controls provisions of the Act include requirements for anising and adulter controls provisions of the Act mercuse requirement solinst misbranding and adulteration. manufacturing practice, labeling, and prohibitions against misbranding and adulterati If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mo elise enajor regulations affecting your device can be may be subject to such additional controls. The 2004 - 100 - 100 may publish may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may publish found in the Code of Federal Regulations, Title 21, Parts 800 to 898tes found in the Code of I cacral regar. further announcements concerning your device in the Federal Register. {1}------------------------------------------------ ## Page 2 – Ms. Cheryl V. Zimmerman Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's Issualice of a substance equirements of the Act or that FDA has made a determination that your device complies with with that FDA has made a determination that your accuration of the Federal are in . You must comply with any Federal statutes and regulations administration and issimon on Listing any Federal statutes and regulations administered by one ristian and listing (21 CFR Part 807); all the Act's requirements, including, but not limited to: registration in the all the Act's requirements, including but norminated to: requirements as services and the quality labeling (21 CFR Part 801); good manufacturing practice requirements as esta labeling (21 CFR Part 801); good manuzaccumng production in electronic product radiation systems (QS) regulation (21 CFR Part 820); and if applices 1000, 100 systellis (QS) regulation (21 CF C-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) . The success of the consisted on the besting tight squirelevice to legal This letter will allow you to begin maketing your active as uslence of your device to a legally premarket notification. The FDA finding of substantial equivale of the permit premarket notification. The FDA Inding of Substantial equilt of 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 rs of the may on any and 11, 2011 5: All any descreate the regulation entit If you desire specific advice for your ac vice on our sa Also, please note the regulation entitled. Contact the Office of Compliance at (240) 276-0115. Also, please note the contact the Other of Compilance at (210) 210 of 2019 12:30 Part 807.97). You may obtain other "Misbranding by reference to premarket notification' (21 CFR Part Division of S "Misbranding by relefence to premailities under the Act from the Division of Small general information on your responsibilities under the Act from the 1900 6 general information on your responsibilities are at its toll-fire number (800) 638-2041 or Manufacturers, international and Collsaner Absocures and Collectivindustry/support/index.html. Sincerely yours, Quattie Y. Michie Davis. 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 Enclosure {2}------------------------------------------------ ## Indications for Use 105/006 510(k) Number (if Known): Device Name: ___iBond™ Next Generation________________________________________________________________________________________________________________________________________ Indications for Use: - Bonding of direct composite restorations (including Polyglas® and Compomer) Composite of the collections its and into light suring luting comport . - Bonding of direct composite restoration with a light-curing luting cement: Bonding of indirect restoration in combination with a light-cenent: crow - . Bonding of indirect restoration in combination with a light only only of the growns). Porcelain, Polyglas®, and composite restorations (inlays, onlays, veneers, crowns). - Sealing hypersensitive areas of teeth. . 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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) and to complete the couple partistic development contraster common valle comments welchines in Susan Runoen (Division Sign-Off), Division of Anesthesiology, General Hospital, Infection Control, Dental Dev Page _1_ of __ 1_ 510(k) Number ._