MIS LOCKiT Abutments System, OT-Equators and Ball Attachments

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 28, 2019 MIS Implants Technologies Ltd. Arbel Shezaf RA Coordinator P.O. Box 7 Bar Lev Industrial Park, 2015600 ISRAEL Re: K18228 Trade/Device Name: MIS LOCKiT Abutments System, OT-Equators and Ball Attachments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: January 3, 2019 Received: January 3, 2019 Dear Arbel Shezaf: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ 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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, ## Andrew I. Steen -S 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}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K182228 Device Name MIS LOCKiT Abutments System, OT-Equators and Ball Attachments Indications for Use (Describe) MIS dental implant systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (03.3mm & UNO) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another. The long MIS (18 & 20 mm) implants can be used in a tilted manner. MIS short implants are to be used only with straight abutments. M4 short implants are indicated for delayed loading only. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for MIS Implants Technologies Ltd. The logo consists of the letters "MIS" in blue, with the "M" and "I" connected and the "S" stylized as a curved line. To the right of the letters, the words "Implants Technologies Ltd." are written in a smaller font size. ### 510(k) Summary #### 1. Submitter MIS Implants Technologies Ltd. P.O. Box 7, Bar Lev Industrial Park 2015600 ISRAEL Telephone: +972-4-9016802 Fax: +972-4-9918623 Contact: Arbel Shezaf Date Prepared: January 22, 2019 #### 2. US Agent: Motti Weisman - VP Marketing MIS Implants Technologies Inc. 18-00 Fair Lawn Ave Fair Lawn NJ 07410 Phone: (201) 797-9144 Fax: (201) 797-9145 #### 3. Device Identification | Trade/Proprietary Name: | MIS LOCKIT Abutments System, OT-Equators and Ball Attachments | |-------------------------|---------------------------------------------------------------| | Common/Usual Name: | Dental implant abutment | | Classification Name: | Endosseous dental implant abutment | | Regulation Number: | 872.3630 | | Product Code: | NHA | | Device Class: | Class II | | Classification Panel: | Dental Devices Panel | #### 4. Predicate Device(s) Primary predicate device: - . MIS Conical Connection Equators cleared under K163349 Reference devices: - . Zest Locator® Implants Attachments cleared under K072878 - MIS Conical Connection Equators cleared under K172505 - MIS Internal Hex Connection Equators cleared under K180282 ● - MIS CONNECT Conical Connection Abutment cleared under K173326 ● {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo features the letters "MIS" in a stylized, connected font, with the "I" appearing as a vertical line. To the right of the logo is the text "Implants Technologies Ltd." in a smaller, sans-serif font. - MIS Conical Connection Implants cleared under K112162 . - MIS Dental Implant System cleared under K040807 ● #### 5. Device Description #### a. MIS LOCKiT Abutments System MIS LOCKiT abutments system contains titanium abutments coated with titanium nitride (TiN). MIS LOCKIT abutments system is intended to be used in completely edentulous jaws and connects to an overdenture to allow its insertion and removal. MIS LOCKiT abutments connect directly to the implant by their threading. MIS LOCKiT abutments are available in three different platforms (narrow platform (NP), standard platform (SP) and wide platform (WP)) and two connection types (conical connection and internal hex connection). LOCKiT abutments system contains straight abutments only. MIS LOCKiT abutments are provided in the following gingival heights: - . Narrow platform: 1, 2, 3, 4, 5 mm - . Standard platform: 1, 2, 3, 4, 5 mm - Wide platform: . 1, 3, 5 mm MIS LOCKIT internal hex connection abutments are compatible with MIS internal hex implants cleared under K040807 and K180282 (M4, LANCE and SEVEN Systems). MIS LOCKiT conical connection abutments are compatible with MIS implants cleared under K112162, K163349 and K172505 (C1 and V3 Systems). #### b. OT-Equators and Ball Attachments Ball Attachments and OT-Equators are used to connect to an overdenture bar to allow its insertion and removal. They are connected directly to the implant by their distal threading, and are mostly used in complete edentulous jaws. The main difference between them is that ball attachments have a higher profile and ball shaped head, while the OT-equators have a lower profile and a truncated head. Both are made from Titanium 6Al-4V ELI and feature a Titanium Nitride (TiN) coating for increased resistance to wear. Internal hex OT-Equators and Ball Attachments are available in three different platforms (narrow platform (NP), standard platform (SP) and wide platform (WP) and are available in the following gingival heights: - . Narrow platform: 1, 2, 3, 4, 5 mm - . Standard platform: 1, 2, 3, 4, 5 mm - Wide platform: 1, 3, 5 mm . MIS Internal hex OT-Equators and Ball Attachments are compatible with MIS internal hex implants cleared under K040807 and K180282 (M4, LANCE and SEVEN Systems). {5}------------------------------------------------ # s Technologies Ltd. #### 6. Indications for Use MIS dental implant systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm & UNO) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another. The long MIS (18 & 20 mm) implants can be used in a tilted manner. MIS short implants are to be used only with straight abutments. M4 short implants are indicated for delayed loading only. #### 7. Substantial Equivalence Discussion #### a. MIS LOCKiT Abutments System: The predicate device for the Conical Connection MIS LOCKiT abutments is MIS Conical Connection Equators cleared under K163349 and K172505, while the predicate device for the Internal Hex Connection MIS LOCKiT abutments is the MIS Internal Hex Connection Equators recently cleared under K180282. Two reference devices for MIS LOCKIT abutments are also included, specifically, the Zest Locator® Implants Attachments (K072878) and MIS CONNECT Concal Connection Abutment (K173326). All devices have identical intended use. The indications listed for the LOCKiT are identical to the indications for MIS Equators and do not meaningfully differ from the Zest Locator. All abutments are made from titanium or its alloy, and undergo TiN coating. In regards to the distal geometry, the conical implant connection geometry for the Conical Connection MIS LOCKIT is identical to the MIS Conical Connection Equators while the internal hex connection is equivalent to MIS Internal Hex Connection Equators. The subject and the predicate devices are available in the same gingival heights - 1, 2, 3, 4, 5 mm (both conical and internal hex connection, narrow and standard platform) and 1, 3, 5 mm (both conical and internal hex connections, wide platform). MIS CONNECT Conical Connection Abutments and Zest Locator® Implants Attachments were chosen as a reference device in terms of fatigue limit. MIS LOCKIT abutment (internal hexagon connection, NP and SP) were tested in order to determine the fatigue limit value of an implant-abutment assembly. The endurance limit for the LOCKiT assembly was compared with the corresponding worst case for CONNECT and Zest Locator® systems. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "mis" in blue. The letters are connected and stylized, with the "m" having a wavy appearance, the "i" having a dot above it, and the "s" having a curved shape. The text is simple and clean, with a focus on readability. #### Implants Technologies Ltd. | Trade Name | MIS LOCKIT<br>Abutments (conical<br>and internal hex<br>connection)<br>New device | MIS Equators<br>(conical and internal<br>hex connection)<br>Primary predicate | MIS CONNECT<br>Conical Connection<br>Abutments<br>Reference device<br>(fatigue strength) | ZEST Locator ®<br>Implants Attachments<br>Reference device<br>(proximal connection) | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | Subject | Conical<br>Connection:<br>K163349, K172505<br>Internal Hex<br>Connection:<br>K180282 | K173326 | K072878 | | Manufacturer | MIS Implants<br>Technologies Ltd. | MIS Implants<br>Technologies Ltd. | MIS Implants<br>Technologies Ltd. | Zest Anchors LLC. | | Device Class | Class II | Class II | Class II | Class II | | Product Code(s) | NHA | NHA | NHA | NHA | | Regulation | Endosseous dental | Endosseous dental | Endosseous dental | Endosseous dental | | Description | implant abutment | implant abutment | implant abutment | implant abutment | | Regulation | 872.3630 | 872.3630 | 872.3630 | 872.3630 | | Number | | | | | | Intended use: | Dental implant<br>abutments are<br>intended to be used<br>in the upper or lower<br>jaw and used for<br>supporting tooth<br>replacements to<br>restore chewing<br>function. The<br>abutments in<br>combination with<br>endosseous implants<br>are used as the<br>foundation for<br>anchoring tooth<br>replacements in<br>either jaw. Intended<br>for fully edentulous<br>jaw retaining a tissue<br>supported<br>overdenture. | Dental implant<br>abutments are<br>intended to be used<br>in the upper or lower<br>jaw and used for<br>supporting tooth<br>replacements to<br>restore chewing<br>function. The<br>abutments in<br>combination with<br>endosseous implants<br>are used as the<br>foundation for<br>anchoring tooth<br>replacements in<br>either jaw. Intended<br>for fully edentulous<br>jaw retaining a tissue<br>supported<br>overdenture. | Dental implant<br>abutments are<br>intended to be used<br>in the upper or lower<br>jaw and used for<br>supporting tooth<br>replacements to<br>restore chewing<br>function. The<br>abutments in<br>combination with<br>endosseous implants<br>are used as the<br>foundation for<br>anchoring tooth<br>replacements in<br>either jaw. Intended<br>for fully edentulous<br>jaw retaining a tissue<br>supported<br>overdenture. | Dental implant<br>abutments are intended<br>to be used in the upper<br>or lower jaw and used<br>for supporting tooth<br>replacements to restore<br>chewing function. The<br>abutments in<br>combination with<br>endosseous implants are<br>used as the foundation<br>for anchoring tooth<br>replacements in either<br>jaw. Intended for fully<br>edentulous jaw<br>retaining a tissue<br>supported overdenture. | | Indications for<br>use: | MIS dental implant<br>systems are intended<br>to be surgically<br>placed in the bone of<br>the upper or lower<br>jaw arches to provide<br>support for prosthetic<br>devices, such as<br>artificial teeth, in<br>order to restore<br>masticatory function.<br>When a one-stage<br>surgical procedure is | MIS dental implant<br>systems are intended<br>to be surgically<br>placed in the bone of<br>the upper or lower<br>jaw arches to provide<br>support for prosthetic<br>devices, such as<br>artificial teeth, in<br>order to restore<br>masticatory function. | MIS Dental Implant<br>Systems are intended<br>to be surgically<br>placed in the bone of<br>the upper or lower<br>jaw arches to provide<br>support for prosthetic<br>devices, such as<br>artificial teeth, in<br>order to restore<br>masticatory function. | The Locator® Implant<br>Attachment System is<br>designed for use with<br>overdentures or partial<br>dentures, retained in<br>whole or in part, by<br>endosseous implants in<br>the mandible or<br>maxilla. | | Trade Name | MIS LOCKIT<br>Abutments (conical<br>and internal hex<br>connection)<br>New device | MIS Equators<br>(conical and internal<br>hex connection)<br>Primary predicate | MIS CONNECT<br>Conical Connection<br>Abutments<br>Reference device<br>(fatigue strength) | ZEST Locator ®<br>Implants Attachments<br>Reference device<br>(proximal connection) | | | applied, the implant<br>may be immediately<br>loaded when good<br>primary stability is<br>achieved and the<br>occlusal load is<br>appropriate.<br>Narrow implants<br>(Ø3.3mm & UNO)<br>are indicated for use<br>in surgical and<br>restorative<br>applications for<br>placement only in the<br>mandibular central,<br>lateral incisor and<br>maxillary lateral<br>incisor regions of<br>partially edentulous<br>jaws, to provide<br>support for prosthetic<br>devices such as<br>artificial teeth.<br>Mandibular central<br>and lateral incisors<br>must be splinted if<br>using two or more<br>narrow implants<br>adjacent to one<br>another.<br>The long MIS (18 &<br>20 mm) implants can<br>be used in a tilted<br>manner.<br>MIS short implants<br>are to be used only<br>with straight<br>abutments.<br>M4 short implants<br>are indicated for<br>delayed loading only. | When a one-stage<br>surgical procedure is<br>applied, the implant<br>may be immediately<br>loaded when good<br>primary stability is<br>achieved and the<br>occlusal load is<br>appropriate.<br>Narrow implants<br>("3.3mm & UNO)<br>are indicated for use<br>in surgical and<br>restorative<br>applications for<br>placement only in the<br>mandibular central,<br>lateral incisor and<br>maxillary lateral<br>incisor regions of<br>partially edentulous<br>jaws, to provide<br>support for prosthetic<br>devices such as<br>artificial teeth.<br>Mandibular central<br>and lateral incisors<br>must be splinted if<br>using two or more<br>narrow implants<br>adjacent to one<br>another.<br>For the internal hex<br>connection MIS<br>Equators, there is a<br>following addition to<br>the indications for<br>use:<br>The long MIS (18 &<br>20 mm) implants can<br>be used in a tilted<br>manner.<br>MIS short implants<br>are to be used only<br>with straight<br>abutments.<br>M4 short implants<br>are indicated for | When a one-stage<br>surgical procedure is<br>applied, the implant<br>may be immediately<br>loaded when good<br>primary stability is<br>achieved and the<br>occlusal load is<br>appropriate.<br>Narrow implants<br>(Ø3.3mm) are<br>indicated for use in<br>surgical and<br>restorative<br>applications for<br>placement only in the<br>mandibular central,<br>lateral incisor and<br>maxillary lateral<br>incisor regions of<br>partially edentulous<br>jaws, to provide<br>support for prosthetic<br>devices such as<br>artificial teeth, in<br>order to restore the<br>patient chewing<br>function. Mandibular<br>central and lateral<br>incisors must be<br>splinted if using two<br>or more narrow<br>implants adjacent to<br>one another. | | | Trade Name | MIS LOCKIT<br>Abutments (conical<br>and internal hex<br>connection)<br>New device | MIS Equators<br>(conical and internal<br>hex connection)<br>Primary predicate | MIS CONNECT<br>Conical Connection<br>Abutments<br>Reference device<br>(fatigue strength) | ZEST Locator ®<br>Implants Attachments<br>Reference device<br>(proximal connection) | | | | delayed loading only. | | | | Material(s) | Ti 6A1 4V ELI | Ti 6A1 4V ELI | Ti 6A1 4V ELI | Ti 6A1 4V ELI | | Surface<br>Treatment | TiN coating, SP and<br>WP also color<br>anodized | TiN coating, SP and<br>WP also color<br>anodized | Anodized | TiN coating | | Connection of the<br>Abutment to the<br>Implant | • Conical<br>Connection<br>without indexes<br>• Internal Hex<br>Connection | • Conical<br>Connection<br>without indexes<br>• Internal Hex<br>Connection | • Conical<br>Connection<br>without indexes | • Conical<br>Connection<br>without indexes<br>• Internal Hex<br>Connection | | Gingival height | NP / SP (both<br>connections): 1, 2, 3,<br>4, 5 mm<br>WP (both<br>connections): 1, 3, 5<br>mm | NP / SP: 1, 2, 3, 4, 5<br>mm<br>WP: 1, 3, 5 mm | NP: 2, 3 mm<br>SP: 1.5, 2, 3, 4 mm<br>WP: 1.5, 2, 3, 4 mm | NP / SP (conical<br>connection ): 1, 2, 3, 4,<br>5 mm<br>NP / SP / WP (internal<br>hex connection ): 0, 1,<br>2, 3, 4, 5, 6 mm | | Platform | NP / SP / WP (both<br>connections) | NP / SP / WP | NP / SP / WP | Conical Connection:<br>NP / SP<br>Internal Hex<br>Connection: NP / SP /<br>WP | | Abutment<br>Angulation | 0° | 0° | 0°…