Dental Implants and Abutments

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Ditron Dental LTD Tali Hazan RA Consultant M.P Upper Galilee Ramot-Naftali, 1383000 ISRAEL April 30, 2024 Re: K233231 Trade/Device Name: Dental Implants and Abutments Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: March 29, 2024 Received: April 1, 2024 Dear Tali Hazan: 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 (the 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 available 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}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. {2}------------------------------------------------ 3 For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K233231 Device Name Dental Implants and Abutments #### Indications for Use (Describe) Ditron's Dental Implants and Abutments are 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. · Two stage: MPI, ULT, API and CPI models - · One stage: OPI and TPI models The 3.3 and 3.0mm diameter models for One stage OPI and TPI, Two stage and API implants are intended only for the incisors and cuspids of the maxilla and mandible. They are also indicated for denture stabilization using multiple implants. Two stage and One stage implants for temporary or long-term use: MPI, ULT, API, CPI, OPI and TPI are self-tapping Titanium threaded screws indicated for long term intra bony applications. They permit immediate splint stability and longterm fixation of new or existing crown, bridge and prosthesis and protection of graft sites. MPI, ULT, API, CPI, OPI and TPI designs are indicated for immediate loading (except for MPI and API in 6.0mm length) when good primary stability is achieved and with appropriate occlusal loading. MPI, ULT, API, CPI, OPI and TPI are indicated for immediate loading (except for MPI and API in 6.0mm length) in single tooth restorations when good primary stability is achieved with appropriate occlusal loading. The 30-degree multi-unit abutments must be used within 45 degrees of parallelism for a splinted restoration. The 17-degree multi-unit abutments must be used within 32 degrees of parallelism for a splinted restoration. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|---------------------------------------------| | × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Ditron Dental. The logo consists of a green square with a white triangle cut out of the center on the left side. To the right of the square are the words "DITRON" on top of the word "DENTAL" in a sans-serif font. # 510(k) Summary for # Ditron's Dental Implants and Abutments ### Date Prepared: April 25, 2024 - 1. Submitter | Company name: | Ditron Precision Ltd. | |---------------|-----------------------------------| | Address: | 2 Haofe St Ashkelon, 78150 Israel | | Phone: | +972-8-6711841 | | E-mail: | ariel@ditronprecision.com | #### Contact person: | Name: | Ms. Tali Hazan – RA Consultant | | | |----------|---------------------------------------------------|--|--| | Address: | Ramot Naftali, M.P Upper Galilee, 1383000, Israel | | | | Phone: | +972-(0)50-5292-304 | | | | E-mail: | tali.hazan@talmed.co.il | | | - 2. Device Common or usual name: Dental Implants and Abutments Proprietary/Trade name: Dental Implants and Abutments Implants subtypes: TPI – Tissue Level (One Piece) Precision Implant Classification name: Endosseous Dental Implant (21 CFR 872.3640) Regulatory Class: II Product Code: Primary: DZE, Secondary: NHA #### 3. Predicate Device The devices within this submission are substantially equivalent to the following predicate/reference devices: - Primary Predicate Device: Ditron Precision Ltd's legally marketed Dental Implants and . Abutments, cleared under 510(k) number K140728. - Reference Device: Ditron Precision Ltd's legally marketed Dental Implants and Abutments, . cleared under 510(k) number K161497. - . Reference Device: TRI Dental Implants' legally marketed TRI-matrix® Tissue-Level implant, cleared under K203660. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Ditron Dental. The logo consists of a green abstract shape on the left, followed by the words "DITRON" and "DENTAL" stacked on top of each other. The word "DITRON" is on the top line, and the word "DENTAL" is on the bottom line. #### Device Description: 4. This submission covers changes related to Ditron's Dental implants and abutments. The inclusion of additional product variations aims to provide dental surgeons with a broader range of implant and abutment options for patient treatment. The requested additions to Ditron's Dental Implants and Abutments within this 510(k) are hereby described: . An additional implant type: TPI (Tissue Level (One Piece) Precision Implant) -The TPI design is based on Ditron's cleared MPI Implant model and the 3.0mm Straight Multi-Unit Abutment, creating a one-piece implant. The TPI's implant part is identical to the cleared MPI Implant model, and the 3.0mm MPI Straight Multi-unit part has minor dimensional modifications and color anodization for aesthetic purposes. The TPI compatible Cover and Prosthetic Screws are color anodized as well. An additional Abutment type: TPI Healing Caps Abutment -● The TPI Healing Caps design is based on Ditron's cleared Cylindered Healing Caps. The TPI Healing Caps are color-anodized for aesthetic purposes. The TPI Healing Caps Abutments are available in several Gingival height dimensions of 3.5, 4.5 and 5.5mm. - . Modification to Cleared Titanium Abutments – Addition of color anodization as an option for all of the Ditron Dental System Titanium Alloy Grade 23 (Ti 6Al-4V ELI) Abutments cleared under K140727 and K161497, to enhance the aesthetic outcome of the dental prosthetics. - An additional Abutment type: TPI Titanium Coping Abutments The TPI Titanium ● Coping Abutment design is based on Ditron's cleared Temporary Abutment. The TPI Titanium Coping Abutments are directly connected to the endosseous dental implant and are intended to provide a basis for prosthetic restoration of single (Crown) or multiple teeth (Bridge). The TPI Titanium Coping Abutment is available in several lengths and restoration options: 11.0mm Bridge, 11.0 Crown, 4.5mm Bridge, 4.5mm Crown. - An additional Abutment type: TPI Overdenture Liberator Abutment The TPI ● Overdenture Liberator Abutment design is based on Ditron's cleared Liberator Abutment. The Liberator Abutment is available in several length dimensions of 2.0, 3.0, 4.0 and 5.0mm. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Ditron Dental. The logo consists of a green letter D on the left and the words "DITRON DENTAL" in black on the right. The letter D is stylized with a white line running through it. #### 5. Indications for Use: Ditron's Dental Implants and Abutments are 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. - . Two stage: MPI, ULT, API and CPI models - . One stage: OPI and TPI models The 3.3 and 3.0mm diameter models for One stage OPI and TPI, Two stage and API implants are intended only for the incisors and cuspids of the maxilla and mandible. They are also indicated for denture stabilization using multiple implants. Two stage and One stage implants for temporary or long-term use: MPI, ULT, API, CPI, OPI and TPI are self-tapping Titanium threaded screws indicated for long term intra bony applications. They permit immediate splint stability and long-term fixation of new or existing crown, bridge and prosthesis and protection of graft sites. MPI, ULT, API, CPI, OPI and TPI designs are indicated for immediate loading (except for MPI and API in 6.0mm length) when good primary stability is achieved and with appropriate occlusal loading. MPI, ULT, API, CPI, OPI and TPI are indicated for immediate loading (except for MPI and API in 6.0mm length) in single tooth restorations when good primary stability is achieved with appropriate occlusal loading. The 30° multi-unit abutments must be used within 45 degrees of parallelism for a splinted restoration. The 17° multi-unit abutments must be used within 32 degrees of parallelism for a splinted restoration. #### Technological Characteristics and Substantial Equivalence: 6. The subjected devices are substantially equivalent to Ditron's Dental Implants and Abutments that were cleared under K140728 and K161497, and with TRI Dental Implants' TRI-matrix® Tissue-Level implant cleared under K203660, as identified above under the 'predicate devices' section. The indications for use are identical between the primary predicate and subject device indications for use statement, except for the addition of the TPI model. The additional TPI dental implants and abutments and Ditron's cleared predicate devices have the same indications for use, same shape, design and characteristics. The only characteristics that are not covered by the Ditron cleared predicates is the color anodization of the tissue level part of subject implant and abutments. This characteristic is equivalent to the TRI-matrix® Tissue-Level implant. All of the changes that differentiate the additional TPI dental implants and abutments from the predicate devices were addressed and evaluated. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for Ditron Dental. The logo consists of a green square with a white "V" shape inside, followed by the text "DITRON" in black, and "DENTAL" in black below it. The logo is simple and modern, with a focus on the company name. ### Table 1: Substantial Equivalence Table - Intended use | - Subject Device -<br>TPI Implant | - Primary Predicate Device -<br>Ditron's Dental Implants and<br>Abutments [MPI, OPI and Multi-Unit<br>Abutment] Cleared under K140728 | - Reference Device -<br>Ditron's Dental Implants and<br>Abutments [MPI L6.0mm and<br>Liberator] Cleared under K161497 | - Reference Device -<br>TRI Dental Implants'<br>TRI-matrix® Implant<br>Line [TRI-matrix®<br>Tissue-Level]<br>Cleared under<br>K203660 | Substantial<br>Equivalence<br>Discussion | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Ditron's Dental Implants and Abutments<br>are indicated for use in surgical and<br>restorative applications for placement in<br>the bone of the upper or lower jaw to<br>provide support for prosthetic devices,<br>such as artificial teeth, in order to restore<br>the patient's chewing function.<br>•Two stage: MPI, ULT, API and CPI<br>models<br>• One stage: OPI and TPI models<br>The 3.3 and 3.0mm diameter models for<br>One stage OPI and TPI, Two stage MPI,<br>Two stage and API implants are intended<br>only for the incisors and cuspids of the<br>maxilla and mandible. They are also<br>indicated for denture stabilization using<br>multiple implants.<br>Two stage and One stage implants for<br>temporary or long-term use: MPI, ULT,<br>API, CPI, OPI, and TPI are self-tapping<br>Titanium threaded screws indicated for<br>long term intra bony applications. They<br>permit immediate splint stability and long-<br>term fixation of new or existing crown, | Ditron's Dental Implants and<br>Abutments are indicated for use in<br>surgical and restorative applications<br>for placement in the bone of the<br>upper or lower jaw to provide support<br>for prosthetic devices, such as<br>artificial teeth, in order to restore the<br>patient's chewing function.<br>• Two stage: MPI, and CPI models<br>• One stage: OPI model<br>One stage and One piece OPI 3.3 and<br>3.0 mm diameter implants are<br>intended only for the incisors and<br>cuspids of the maxilla and mandible.<br>They are also indicated for denture<br>stabilization using multiple implants.<br>Two stage and One stage implants for<br>temporary or long-term use: MPI,<br>CPI, OPI are self-tapping Titanium<br>threaded screws indicated for long<br>term intra bony applications. They<br>permit immediate splint stability and<br>long-term fixation of new or existing<br>crown, bridge and prosthesis and<br>protection of graft sites. | Ditron's Dental Implants and Abutments are<br>indicated for use in surgical and restorative<br>applications for placement in the bone of the<br>upper or lower jaw to provide support for<br>prosthetic devices, such as artificial teeth, in<br>order to restore the patient's chewing<br>function.<br>• Two stage: MPI, ULT, API and CPI<br>models<br>• One stage: OPI model<br>The 3.3 and 3.0mm diameter models for One<br>stage OPI, Two stage MPI, Two stage and<br>API implants are intended only for the<br>incisors and cuspids of the maxilla and<br>mandible. They are also indicated for<br>denture stabilization using multiple<br>implants.<br>Two stage and One stage implants for<br>temporary or long-term use: MPI, ULT,<br>API, CPI, OPI are self-tapping Titanium<br>threaded screws indicated for long term intra<br>bony applications. They permit immediate<br>splint stability and long-term fixation of new<br>or existing crown, bridge and prosthesis and<br>protection of graft sites. | The TRI-matrix®<br>Implant Line is intended<br>for placement in the bone<br>of the maxillary or<br>mandibular arch for the<br>rehabilitation of<br>edentulous and partially<br>edentulous patients.<br>TRI-matrix® Implant<br>Line allows for one and<br>two stage surgical<br>procedures. When a one<br>stage surgical procedure<br>is applied, the implant<br>may be immediately<br>loaded when good<br>primary stability is<br>achieved and with<br>appropriate occlusal<br>loading. TRI-matrix®<br>Implant Line 6.5 mm<br>implants are intended for<br>delayed loading only.<br>The TRI-matrix® Crown | Same.<br>All predicate<br>devices<br>(primary and<br>references),<br>have the same<br>indications for<br>use. The MPI<br>length<br>dimensions<br>greater than<br>6.0mm, multi-<br>unit abutments,<br>and the One-<br>Piece design<br>concept were<br>leveraged from<br>510(k) K14072<br>and the 6.0mm<br>lengths of the<br>TPI together<br>with the<br>modified<br>Liberator, were | | | | | | Abutment is intended for | leveraged from | | | - Subject Device -<br>TPI Implant | - Primary Predicate Device -<br>Ditron's Dental Implants and<br>Abutments [MPI, OPI and Multi-Unit<br>Abutment] Cleared under K140728 | - Reference Device -<br>Ditron's Dental Implants and<br>Abutments [MPI L6.0mm and<br>Liberator] Cleared under K161497 | - Reference Device -<br>TRI Dental Implants'<br>TRI-matrix® Implant<br>Line [TRI-matrix®<br>Tissue-Level]<br>Cleared under<br>K203660 | Substantial<br>Equivalence<br>Discussion | | | bridge and prosthesis and protection of | MPI, CPI, and OPI designs are | MPI, ULT, API, CPI and OPI designs are | use with an endosseous | 510(k) K161497 | | | graft sites. | indicated for immediate loading when | indicated for immediate loading (except for | implant to function as a | for the addition | | | MPI, ULT, API, CPI, OPI and TPI designs | good primary stability is achieved | MPI and API in 6.0mm length) when good | substructure that also | TPI model. | | | are indicated for immediate loading | and with appropriate occlusal | primary stability is achieved and with | serves as the final | The TRI | | | (except for MPI and API in 6.0mm length) | loading. MPI, CPI and OPI are | appropriate occlusal loading. | restoration, in a partially | reference device | | | when good primary stability is achieved | indicated for immediate loading in | MPI, ULT, API, CPI and OPI are indicated | or completely edentulous | includes a | | | and with appropriate occlusal loading. | single tooth restorations when good | for immediate loading (except for MPI and | patient. The abutment | crown that is not | | | MPI, ULT, API, CPI, OPI and TPI are | primary stability is achieved with | API in 6.0mm length) in single tooth | screw is intended to | part of the | | | indicated for immediate loading (except | appropriate occlusal loading. | restorations when good primary stability is | secure the TRI-matrix® | subject device | | | for MPI and API in 6.0mm length) in | The 30-degree multi-unit abutments | achieved with appropriate occlusal loading. | Crown Abutment to the | and therefore | | | single tooth restorations when good | must be used within 45 degrees of…