ITI DENTAL IMPLANT SYSTEM

{0}------------------------------------------------ 031055 # ATTACHMENT 6 ### 510(k) Summary JUL 0 7 2003 #### 1. Applicant's Name and Address Straumann USA (on behalf of Institut Straumann AG) Reservoir Place 1601 Trapelo Road Waltham, MA 02451 Telephone Number: 800-448-8168 Fax Number: 781-890-0791 Linda Jalbert Contact Person: Director, Requlatory Affairs #### 2. Name of the Device Trade Name: ITI® DENTAL IMPLANT SYSTEM Common Name: Endosseous dental implants Classification Name: Endosseous dental implants 21 CFR 872.3640 ### 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) ITI Dental Implant System Implant Innovations Inc. Osseotite Dental Implants(K013570) #### Description of the Device 4. ITI implants have an anchorage surface that is grit blasted then acid etched (SLA surface) or titanium plasma-sprayed (TPS surface). The implants are composed of Grade 4 titanium, cold worked. The neck of the implant, intended to remain above the crest of the bone on implantation, is a smooth machined surface to allow for the attachment of epithelial tissue. ITI implants are available in a range of endosseous diameters (3.3 to 4.8 mm) and lengths. #### 5. Indications for Use ITI implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The ITI Dental Implants are for single-stage or twostage surgical procedures. {1}------------------------------------------------ #### Basis for Substantial Equivalence 6. The subject ITI® dental implants are identical in intended use to currently marketed ITI® dental implants. As with the predicate device, Implant Innovations Inc. Osseotite Dental Implants, the contraindication regarding tobacco use has been removed. The subject ITI® implants are identical in all respects to previously cleared ITI implants. There has been no change in material, surface treatment, design, or operating principle. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The caduceus is composed of three curved lines that resemble a human profile. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 0 7 2003 Ms. Linda Jalbert Director, Regulatory Affairs Straumann USA Reservoir Place 1601 Trapelo Road Waltham, Massachusetts 02451 Re: K031055 Trade/Device Name: ITI® Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: April 2, 2003 Received: April 9, 2003 Dear Ms. Jalbert: 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. 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 affecting vour 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. Jalbert 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 Office of Compliance at (301) 594-4613. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely vours. Susan Puarer Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ Enclosure {4}------------------------------------------------ # ATTACHMENT 8 ## Indications for Use Statement ### Device Name: ITI® Dental Implant System ### Indications for Use: ITI implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The ITI Dental Implants are for single-stage or two-stage surgical procedures. Kim Rudy for MSN (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number:________________________________________________________________________________________________________________________________________________________________ ity A