MRI Compatibility for Existing Zimmer Dental Implant Systems

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, layered on top of each other, creating a sense of depth and unity. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 17, 2017 Zimmer Dental, Inc. Christina Boydston Regulatory Affairs Manager 1900 Aston Ave. Carlsbad, California 92008 Re: K160398 Trade/Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: April 14, 2017 Received: April 17, 2017 Dear Christina Boydston: 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. 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 of medical devicerelated 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Image /page/1/Picture/7 description: The image shows the name "Michael J. Ryan -S" in a large, sans-serif font. The text is black and appears to be on a white background. The name is written in a clear and legible manner. for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a light blue circle with a stylized letter 'Z' inside. Below the circle, the word 'zimmer' is written in a similar light blue color, with the word 'dental' underneath in a smaller font. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Tapered Screw-Vent Zimmer Dental Implant Zimmer dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. × Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {3}------------------------------------------------ Image /page/3/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a stylized letter 'Z' in a light blue color, positioned above the words 'zimmer' and 'dental'. The word 'zimmer' is in a similar light blue color, while 'dental' is in a smaller font size and placed directly below 'zimmer'. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Zimmer One-Piece (ZOP) Dental Implant Zimmer One-Piece Implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the mandibular central incisor, and maxillary lateral incisor regions of partially edentulous jaws. The Zimmer One-Piece Implant must be splinted if two or more are used adjacent to each other. The Zimmer One-Piece Implant may be immediately restored with a temporary prosthesis that is not in functional occlusion × Prescription Use AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a stylized letter "Z" in a light blue color, positioned above the word "zimmer" in a smaller, sans-serif font, also in light blue. Below "zimmer" is the word "dental" in a smaller, italicized font, underlined with a thin line. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Screw-Vent Zimmer Dental Implant Zimmer Dental implant systems are designed for use in endentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {5}------------------------------------------------ Image /page/5/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a light blue circle with a stylized letter 'Z' inside. Below the circle, the word 'zimmer' is written in a similar light blue color, with the word 'dental' underneath in a smaller font. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Advent Zimmer Dental Implant Zimmer dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. × Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {6}------------------------------------------------ Image /page/6/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a light blue circle with a stylized "Z" inside. Below the circle, the word "zimmer" is written in a sans-serif font, also in light blue. Underneath "zimmer", the word "dental" is written in a smaller font size and is underlined. 510(k) Number (if known): _ K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: SwissPlus Dental Implant Zimmer Dental implant systems are designed for use in endentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. × Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {7}------------------------------------------------ Image /page/7/Picture/2 description: The image contains the logo for Zimmer Dental. The logo features a light blue circle with a stylized letter 'Z' inside. Below the circle, the word 'zimmer' is written in a similar light blue color, with the word 'dental' appearing in a smaller font size directly underneath. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Spline Twist Dental Implant Zimmer Dental implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. × Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {8}------------------------------------------------ Image /page/8/Picture/2 description: The image contains the logo for Zimmer Dental. The logo features a large, stylized letter 'Z' in a light blue color, positioned above the words 'zimmer' and 'dental'. The word 'zimmer' is in a similar light blue color and is placed above the word 'dental', which is in a smaller font size and underlined with a thin line. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Trabecular Metal Implant™ (Tapered Screw Vent® X Implant System) Zimmer Dental implant systems are (Tapered Screw Vent® X Implant System) designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. The 3.7mmD Trabecular Metal Implants should be splinted to additional implants when used in the pre- molar region and should not be used in the molar region. The 4.1mmD Trabecular Metal Implants should be splinted to additional implants when used in the molar region. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) #### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {9}------------------------------------------------ Image /page/9/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a blue letter Z inside of a circle. Below the circle are the words "zimmer" and "dental" in a smaller font size. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Zimmer 3.1mmD Dental Implants The 3.1mmD Eztetic Dental Implants are designed for use in the anterior maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. The 3.1mmD Eztetic Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to minimally support the implant (minimum 1mm circumferential and 2mm apical). The 3.1mmD Eztetic Dental Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region. × AND/OR Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {10}------------------------------------------------ Image /page/10/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a light blue circle with a stylized letter 'Z' inside. Below the circle, the word 'zimmer' is written in a similar light blue color, with the word 'dental' underneath in a smaller font. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Zimmer Dental Tapered Screw-Vent® T Implant, HA Coated & Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated Zimmer dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. × Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) #### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {11}------------------------------------------------ Image /page/11/Picture/2 description: The image contains the logo for Zimmer Dental. The logo features a stylized letter "Z" in a light blue color, positioned above the words "zimmer dental." The word "zimmer" is in a sans-serif font, and the word "dental" is in a smaller font size and placed directly below "zimmer." 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Zimmer Dental Tapered Screw-Vent® T Implant & Zimmer Dental Tapered Screw-Vent® M Implant Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. × Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {12}------------------------------------------------ Image /page/12/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a stylized letter 'Z' in a light blue circle. Below the circle, the word 'zimmer' is written in lowercase, also in light blue, and below that, the word 'dental' is written in a smaller font size and gray color. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Zimmer Contour Hex-Lock Abutment, Straight Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. Abutment can be used for a single or multiple-unit restoration. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {13}------------------------------------------------ Image /page/13/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a stylized letter "Z" in a light blue color, positioned above the words "zimmer" and "dental," also in light blue. The word "zimmer" is in a larger, bolder font compared to "dental," which is placed directly underneath it. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Zimmer Contour Hex-Lock Abutment, 17° Abutment is used as a terminal or intermediate abutment for a cemented prosthesis where the angle needs to be offset by 17°. Abutment can be used for a single or multiple-unit restoration. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {14}------------------------------------------------ Image /page/14/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a stylized letter "Z" in a light blue color, positioned above the words "zimmer" and "dental," also in light blue. The word "zimmer" is in a larger, bolder font compared to "dental," which is placed directly underneath it. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Zimmer Dental Inc. Hex-Lock Abutment Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. Abutment can be used for a single or multiple-unit restoration. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {15}------------------------------------------------ Image /page/15/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a stylized letter "Z" in a light blue color, positioned above the words "zimmer" and "dental," also in light blue. The word "zimmer" is in a larger, bolder font compared to "dental," which is placed directly underneath it. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Hex-Lock Short Abutments Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. Abutment can be used for a single or multiple-unit restoration. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {16}------------------------------------------------ Image /page/16/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a stylized letter 'Z' in a light blue color, positioned above the words 'zimmer' and 'dental'. The word 'zimmer' is in a similar light blue color, while 'dental' is in a smaller font size and placed directly below 'zimmer'. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Zimmer Dental Inc. 20° Angled Abutment Zimmer Dental Implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {17}------------------------------------------------ Image /page/17/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a stylized letter 'Z' in a light blue color, positioned above the words 'zimmer' and 'dental'. The word 'zimmer' is in a similar light blue color, while 'dental' is in a smaller font size and placed directly below 'zimmer'. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: "Cast-To" Gold Abutments, Engaging Zimmer Dental Implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. × Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {18}------------------------------------------------ Image /page/18/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a light blue circle with a stylized letter 'Z' inside. Below the circle, the word 'zimmer' is written in a bold, sans-serif font, and below that, the word 'dental' is written in a smaller, lighter font. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Zimmer Cast-To Gold Abutment for the 3.1mmD Dental Implant System, Engaging The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System, Engaging is intended for use in the creation of a customized abutment for a cement-retained crown or bridge, or a customized screw-retained restoration. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use_ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {19}------------------------------------------------ Image /page/19/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a light blue circle with a stylized "Z" inside. Below the circle, the word "zimmer" is written in a lowercase, sans-serif font, also in light blue. Underneath "zimmer", the word "dental" is written in a smaller font size and is underlined. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: "Cast-To" Gold Abutments, Non-Engaging Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. × Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {20}------------------------------------------------ Image /page/20/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a large, light blue letter Z above the words "zimmer" and "dental", which are stacked on top of each other. The word "zimmer" is in a larger, bolder font than the word "dental". 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Zimmer Cast-To Gold Abutment for the 3.1mmD Dental Implant System. Non-Engaging The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System. Non-Engaging, is intended for use in the creation of customized multiple-unit restorations on implants (e.g., bars and bridges), when anti-rotation of the abutment is not necessary. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) #### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {21}------------------------------------------------ Image /page/21/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a large, stylized letter "Z" in a light blue color. Below the "Z", the word "zimmer" is written in a smaller, lowercase font, also in light blue. Underneath "zimmer", the word "dental" is written in an even smaller font, with a line above it. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex are used for attachment of restorations requiring off-axis correction. The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex are designed to be used in edentulous or partially edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement. The 2.9mm Contour Abutment and the 2.9mm Contour Abutment, Straight Hex are used as a terminal or intermediate abutment for a cemented prosthesis. Abutment can be used for a singleor multiple-unit restoration. The 2.9mm Angled Contour Abutment and the 2.9mm Angled Contour Abutment, Straight Hex are designed to be used as a terminal or intermediate abutment for a cemented prosthesis where the angle needs to be offset by 17°. Abutment can be used for a single- or multiple-unit restoration. The 2.9mm Temporary Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The 2.9mm Temporary Abutment can be used for cementretained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) #### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {22}------------------------------------------------ Image /page/22/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a stylized letter 'Z' in a light blue circle. Below the circle, the word 'zimmer' is written in lowercase, also in light blue, and below that, the word 'dental' is written in a smaller font size and gray color. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Angled Tapered Abutments, 15° The Angled Tapered Abutment is used for a terminal or intermediate abutment for screwretained multiple-unit restorations. The 30° Angled Tapered Abutment must be used within 45° of parallelism for a splinted restoration. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {23}------------------------------------------------ Image /page/23/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a stylized letter 'Z' in a light blue color, positioned above the words 'zimmer' and 'dental'. The word 'zimmer' is in a similar light blue color, while 'dental' is in a smaller font size and placed directly below 'zimmer'. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Angled Tapered Abutments, 30° The Angled Tapered Abutment is used for a terminal or intermediate abutment for screwretained multiple-unit restorations. The 30° Angled Tapered Abutment must be used within 45°of parallelism for a splinted restoration. The 15° Angled Tapered Abutment must be used within 30° of parallelism for a splinted restoration. × Prescription Use AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {24}------------------------------------------------ Image /page/24/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a stylized letter "Z" in a light blue color, positioned above the words "zimmer" and "dental." The word "zimmer" is in a smaller, sans-serif font, and the word "dental" is in an even smaller font and is underlined. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Zimmer Dental Inc. Screw Vent Ball Abutment Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. × Prescription Use AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {25}------------------------------------------------ Image /page/25/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a blue circle with a stylized letter "Z" inside. Below the circle, the word "zimmer" is written in a sans-serif font, and below that, the word "dental" is written in a smaller, thinner font. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Spline Temporary Abutment Temporary Abutment, Engaging: Spline engaging titanium alloy cylinder with retentive parallel walls and a flared cuff. Attaches to the Spline Implant with a separate screw. For use when a temporary prosthesis for up to six weeks is desired. Single or multiple units. Do not use as a permanent abutment. Not to exceed six weeks of placement. Temporary Abutment, Non-Engaging: Adjustable titanium alloy cylinder with retentive parallel walls and a cuff. Attaches to the Spline Implant with a separate screw. Does not engage the tines. For use when a temporary prosthesis for up to six weeks is desired. Single or multiple units. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) #### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {26}------------------------------------------------ Image /page/26/Picture/2 description: The image contains the logo for Zimmer Dental. The logo features a light blue circle with a stylized letter 'Z' inside. Below the circle, the word 'zimmer' is written in a similar light blue color, with the word 'dental' appearing in a smaller font size directly underneath. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Spline Fixed Abutment For use as a terminal or intermediate abutment for cemented prosthesis. Abutments must be parallel to within 7.5° for Spline Implant or be prepped to be parallel. The Spline Abutments can be used for a single tooth or splinted to other abutments. Single use. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {27}------------------------------------------------ Image /page/27/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a light blue circle with a stylized "Z" inside. Below the circle, the word "zimmer" is written in a sans-serif font, also in light blue. Underneath "zimmer", the word "dental" is written in a smaller font size and is underlined. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Spline Fixed Abutment, 17° For use as a terminal or intermediate abutment for cemented prosthetics when long axis of abutment needs to be changed by 15°, 17° or 25°. Abutment can be used for single tooth or splinted restorations. Single use. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {28}------------------------------------------------ Image /page/28/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a stylized letter Z inside of a circle. Below the circle, the word "zimmer" is written in a lowercase sans-serif font, and below that, the word "dental" is written in a smaller font. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Zimmer Zfx Titanium Abutment for NobelActive Implant System The Zimmer Zfx Titanium Abutment for NobelActive Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with NobelActive and NobelReplace Conical Connection implants with a Narrow Platform (NP) Ø 3.5mm, or Regular Platform (RP) Ø 3.9mm. X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use_ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {29}------------------------------------------------ Image /page/29/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a light blue circle with a stylized letter 'Z' inside. Below the circle, the word 'zimmer' is written in a similar light blue color, with the word 'dental' underneath in a smaller font. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Zimmer Zfx Abutment for NobelReplace Implant System The Zimmer Zfx Abutment for NobelReplace Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with NobelReplace, Replace Select and NobelSpeedyReplace implants with a Narrow Platform (NP) Ø3.5 mm, Regular Platform (RP) Ø 4.3 mm, WidePlatform (WP) Ø 5.0 mm or 6.0 Platform (6.0) Ø 6.0mm. × Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {30}------------------------------------------------ Image /page/30/Picture/2 description: The image contains the logo for Zimmer Dental. The logo features a light blue circle with a stylized "Z" inside. Below the circle, the word "zimmer" is written in a sans-serif font, with the word "dental" written in a smaller font size directly underneath and separated by a horizontal line. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Zimmer Zfx Titanium Abutment for Straumann Bone Level Implant System The Zimmer Zfx Titanium Abutment for Straumann Bone Level Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with Straumann Bone Level implants with a Narrow CrossFit Platform Connection (NC) Ø 3.3mm or Regular CrossFit Platform Connection (RC) Ø 4.1mm or 4.8mm. × Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {31}------------------------------------------------ Image /page/31/Picture/2 description: The image contains the logo for Zimmer Dental. The logo features a light blue circle with a stylized letter 'Z' inside. Below the circle, the word 'zimmer' is written in a lowercase, sans-serif font, and below that, the word 'dental' is written in a smaller, sans-serif font with a line above it. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Zimmer Zfx Titanium Base Abutment for Tapered Screw Vent Implant System The Zimmer Zfx Titanium Base Abutment is a combination of a pre-manufactured (stock) abutment and Zimmer Zfx Abutment Coping or Crown as part of a straight or angled two piece abutment. The combination of the titanium base stock abutment and the abutment coping is designed for use as a terminal or intermediate abutment for cement or screw retained prostheses. The two-piece abutment is used for a single -unit or multi-unit(bridge) restoration. The Zimmer Zfx Abutment Coping shall be manufactured by an approved Zimmer Dental milling facility. Prescription Use AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {32}------------------------------------------------ Image /page/32/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a blue circle with a white "Z" inside. Below the circle, the word "zimmer" is written in blue, with the word "dental" written in a smaller font size below it. The logo is simple and clean, with a focus on the company name. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Zimmer Zfx Abutment for Biomet 3i Certain Implant System Titanium Abutment for Biomet 3i Certain Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with Biomet 3i internal connection implants with a 3.4mm, 4.1mm, 5.0mm, or 6.0mm Platform. × Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {33}------------------------------------------------ Image /page/33/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a blue circle with a stylized letter "Z" inside. Below the circle, the word "zimmer" is written in a sans-serif font, and below that, the word "dental" is written in a smaller, thinner font. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Zimmer® Patient Specific Abutment, Internal Hex, Titanium The Zimmer Patient Specific Abutment, Internal Hex, Titanium is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit restoration. × Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {34}------------------------------------------------ Image /page/34/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a stylized letter 'Z' in a light blue circle. Below the circle, the word 'zimmer' is written in lowercase, also in light blue, and below that, the word 'dental' is written in a smaller font size and gray color. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Tapered Screw-Vent Healing Collar The Healing Collar is used to assist in the forming of the soft tissue during healing before a final restoration is placed. The Healing Collar is for single use only. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {35}------------------------------------------------ Image /page/35/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a light blue circle with a stylized letter "Z" inside. Below the circle, the word "zimmer" is written in a lowercase, sans-serif font, and below that, the word "dental" is written in a smaller, sans-serif font. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: 2.9mm Healing Collar The Healing Collar is used to assist in the forming of the soft tissue during healing before a final restoration is placed. The Healing Collar is for single use only. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {36}------------------------------------------------ Image /page/36/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a stylized letter "Z" in a light blue color, positioned above the word "zimmer" in a smaller, sans-serif font, also in light blue. Below "zimmer" is the word "dental" in a smaller, italicized font, underlined with a thin line. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Zimmer Dental Surgical Cover Screw The Healing Screw is used to seal the implant internal connection and separate it from the soft tissue which is sutured over the implant during healing. The Healing Screw and Surgical Cover Screw are for single use only. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {37}------------------------------------------------ Image /page/37/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a stylized letter "Z" in a light blue color, positioned above the words "zimmer" and "dental," also in light blue. The word "zimmer" is larger and bolder than the word "dental," which is placed directly below it. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: 2.9mm Healing Screw The Healing Screw is used to seal the implant internal connection and separate it from the soft tissue which is sutured over the implant during healing. The Healing Screw is for single use only. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {38}------------------------------------------------ Image /page/38/Picture/2 description: The image contains the logo for Zimmer Dental. The logo features a light blue circle with a stylized letter 'Z' inside. Below the circle, the word 'zimmer' is written in a similar light blue color, with the word 'dental' appearing in a smaller font size directly underneath. 510(k) Number (if known): K160398 Device Name: MRI Compatibility for Existing Zimmer Dental Implant Systems Indications For Use: Retaining Screw The Retaining Screws are intended to be used for securing the temporary abutments, final abutments, and impression transfers to the implant analog. The long Retaining Screw is intended to be used with Temporary Abutments for fabrication of screw-retained provisional restorations and with Impression Transfers for direct impressions. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)