MISTRAL - ONE STAGE SCREW-TYPE DENTAL IMPLANT, MODEL MF9

{0}------------------------------------------------ K070022 Image /page/0/Picture/1 description: The image shows the word "mis" in a stylized font. The letters are connected and have a rounded appearance. The "i" in "mis" is a simple vertical line with a dot above it, and the "s" is a curved shape. APR 2 0 2007 510(k) Summary: Mistral one stage screw-type dental implant Company Name: MIS Implant Technologies Ltd. # Contact Person: Iman Khorshid Quality Manager Telephone: +972-4-980-9966 +972-4-980-9944 Fax: E-mail: iman@mis-implants.com ### Authorized US Agent: Motti Weisman - VP Marketing MIS Implants Technologies Inc. 278 Broadway Elmwood Park, NJ 07407 Phone: (201) 797-9144 Fax: (201) 797-9145 E-mail: mis.service@verizon.net Date prepared: October 26, 2006 Trade Name: Mistral One Stage Screw-type Dental Implant #### Classification: Classification name: Endosseous Dental Implant Common/usual name: Endosseous Dental Implant Product Code: DZE Regulation No .: 872.3640 Class: II Panel identification: Dental Devices Panel {1}------------------------------------------------ # Predicate Device: One stage implant as part of MIS Dental Implant System, MIS Implant Technologies, Shlomi, Israel, cleared under 510(k) no. K040807. #### Description of the device: The Mistral is a one stage, screw-type, internal octagon dental implant and is provided in the following range of dimensions: - Diameters: 3.75. 4.10 and 4.80 mm - - -Length: 8, 10, 11.50, 13 and 16 mm All implants are manufactured from medical grade 5 pure titanium, which meets requirements of standard ASTM F136. The required surface roughness and microgeometry of the implants is achieved by blasting sand particles and acid etching. Blasted surfaces archive more bone contact with the implant surface. #### Indications for Use: The Mistral one stage screw-type dental implant is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. #### Substantial Equivalence: The Mistral single stage screw-type dental implant has the same intended use as the original one stage implant, cleared as part of the MIS dental Implant System under 510(k) no. K040807 and has equivalent performance characteristics. It is therefore substantially equivalent to that device. #### Conclusion: The evaluation of the Mistral single stage screw-type dental implant does not raise any additional concerns regarding safety and effectivity and may therefore be considered substantially equivalent to the predicate device. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # APR 2 0 2007 MIS Implant Technologies, Limited C/O Mr. Motti Weisman Vice President Marketing 278 Broadway Elmwood Park, New Jersey 07407 Re: K070022 Trade/Device Name: Mistral One Stage Screw-Type Dental Implant Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: April 9, 2007 Received: April 19, 2007 Dear Mr. Weisman: 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 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 -Mr. Weisman 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 (240) 276-0115. 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/industry/support/index.html. Sincerely yours, Syrita Y. Michau Oms Chiu Lin, Ph.D. 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 510(k) Number (if known): Device Name: Mistral one stage screw-type dental implant Indications For Use: The Mistral one stage screw-type dental implant is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Prescription Use ﮯ (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) Suse Rusr CONDICION Conars trol, Dema. Devilo 510(k) Number: K072020 Page 1 of 11-2