THE STRAUMANN ORTHO IMPLANT SYSTEM

{0}------------------------------------------------ K04 0469 ## ATTACHMENT 8 ## 510(k) Summary ### Applicant's Name and Address 1 . Straumann USA (on behalf of Institut Straumann AG) Reservoir Place 1601 Trapelo Road Waltham, MA 024511 Telephone Number: 781-890-000 1 Fax Number: 781-890-6464 Contact Person: Carolyn Bitetti Associate Director, Regulatory Affairs #### 2. Name of the Device Trade Name: Common Name: Classification Name: Straumann Ortho implant Endosseous dental implants Endosseous dental implants 21 CFR 872.3640 ### 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) Straumann Ortho System (K982509) ### র্ব . Description of the Device The Ortho implant is a solid, one-piece, threaded, self-tapping design made from CP Grade 4 titanium. It has a sand-blasted, acid etched (SLA) rough surface on the endossous portion of the implant. The transmucosal section of the implant has a smooth machined surface to allow for the attachment of epithelial tissue. The coronal portion of the implant is internally threaded and has a hex head. - Indications for Use 5. CONFIDENTIAL 510(k) Straumann Ortho Implant Page 33 February 17, 2004 {1}------------------------------------------------ The Ortho implant of the Straumann Ortho system is an endosseous implant intended for placement in the mid-sagittal area of the hard palate or in retromolar positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed. ### Basis for Substantial Equivalence 6. The subject Ortho implants are substantially equivalent in intended use to the currently marketed Straumann Ortho implants. The subject Straumann Ortho implants have the same design as the previously cleared Straumann Ortho implants. There has been no change in material, surface treatment, design, or operating principle. CONFIDENTIAL 510(k) Straumann Ortho Implant Page 34 February 17, 2004 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL - 2 2007 Ms. Carolyn Bitetti Associate Director, Regulatory Affairs The Straumann Company Reservoir Place 1601 Trapelo Road Waltham, Massachusetts 02451 Re: K040469 Trade/Device Name: The Straumann Ortho Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: OAT Dated: February 20, 2004 Received: February 24, 2004 Dear Ms. Bitetti: This letter corrects our substantially equivalent letter of April 30, 2004. 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 (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 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. {3}------------------------------------------------ Page 2 - Ms. Bitetti 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 continue 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 Office of Compliance at (240) 276-__(see http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure). Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html. Sincerely yours, Sutte y. Mchier Cus 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 {4}------------------------------------------------ # Indications for Use K040469 510(k) Number (K982509): Device Name: Straumann Ortho Implant Indications for Use: The Ortho implant of the Straumann Ortho system is an endosseous implant intended for placement in the mid-sagittal or paramedian area of the hard palate or in retromolar positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed. Ortho implants can be used in adults and juveniles (age 12 and older). In case of patients who have not yet completed skeletal growth (e.g. as shown by radiographic analysis of the hand/wrist), the ortho implant should be placed off the mid-line in the paramedian region of the palate in order to avoid the midpalatal suture. 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 Device Evaluation (ODE) Robert Betz, DNSL, & Susan Runner Page 1 of 1 (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices CONFIDENTIAL 510(k) Straumann Ortho Implang10(k) Number: 510(k) Straumann Ortho Implang10(k) Number: Bago 38 Page 38 February 17, 2004 Page 38