SIMDA Abutment

{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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. SIMDA Co., Ltd. Young Woo Cha Regulatory Affairs Manager 156-4, Gamjeon-dong Busan, Sasang-gu REPUBLIC OF KOREA Re: K223663 Trade/Device Name: SIMDA Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 26, 2023 Received: April 26, 2023 Dear Young Woo Cha: 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/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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K223663 Device Name SIMDA Abutments #### Indications for Use (Describe) SIMDA Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. It is compatible with the following systems: | Compatible System | Implant Body<br>Diameter(mm) | Implant<br>Platform | |----------------------------------------------------------------------|-------------------------------------------------------------------------|---------------------| | Osstem TS (K121995) | 3.5, 3.75 | Mini | | Osstem TS (K121995) | 3.75, 3.77, 4.2, 4.25, 4.4,<br>4.6, 4.63, 4.65, 4.9, 5.05,<br>5.08, 5.1 | Regular | | Straumann Bone Level<br>(only the Roxolid® implants<br>from K140878) | 3.3 | NC | | Straumann Bone Level<br>(only the Roxolid® implants<br>from K140878) | 4.1, 4.8 | RC | All digitally designed abutments for use with SIMDA Abutments are intended to be sent to a SIMDA validated milling center for manufacture. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> | CONTINUE ON A SEPARATE PAGE IF NEEDED#### 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." {3}------------------------------------------------ #### K 223663 510(k) Summary #### Applicant | Name: | SIMDA Co., Ltd. | |----------------|----------------------------------------------------| | Address: | 156-4, Gamjeon-dong, Sasang-gu, Busan, South Korea | | Phone: | +82 70 4256 2855 | | Contact: | Young Woo, Cha | | Email: | Email: chassi0406@gmail.com | | Date Prepared: | 05/23/2023 | SIMDA Abutment Dental implant abutment 21 CFR 872.3630 NHA Dental Class II Endosseous dental implant abutment #### Subject Device #### Primary Predicate | Trade Name: | TiGEN Abutment, ZrGEN Abutment and Scan Healing | |---------------------|-------------------------------------------------| | Common Name: | Abutment (K220562) | | Classification Name | Endosseous dental implant abutment Abutment | | Product Code: | NHA | | Panel: | Dental | | Regulation Number: | 21 CFR 872.3630 | | Device Class: | Class II | Reference Device Trade Name: OSSTEM TS Fixture System, OSSTEM Implant Co., Ltd. (K121995) Common Name: Classification Name Product Code: Panel: Regulation Number: Device Class: Dental implant abutment Endosseous dental implant abutment DZE, NHA Dental 21 CFR 872.3640 Class II {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "SIMDA" in large, bold, blue letters. The letters are sans-serif and appear to be a uniform thickness. The word is centered and takes up most of the frame. The background is plain white. #### Trade Name: #### Straumann® Bone Level Tapered Implants (K140878) Common Name: Classification Name Product Code: Panel: Regulation Number: Device Class: Dental implant abutment Endosseous dental implant abutment NHA Dental 21 CFR 872.3630 Class II Trade Name: Common Name: Classification Name Product Code: Panel: Regulation Number: Device Class: DD Solid Connect® CAD/CAM AbutmentsAbutment (K19111) Endosseous dental implant abutment Abutment NHA Dental 21 CFR 872.3630 Class II {5}------------------------------------------------ #### Device Description SIMDA Abutment is made of titanium alloy (Ti-6A1-4V ELI. ASTM F136) intended for use as an aid in prosthetic restoration. It consists of Pre-Milled Blank and Ti-Base abutment. It has a premanufactured connection interface that fits directly to an endosseous dental implant. | Design parameter (Patient-specific abutment) | Subject System<br>Design Limit | |---------------------------------------------------------------------------------------------------|--------------------------------| | Minimum and Maximum Gingival (Cuff) Height | 0.5~5mm | | Minimum and Maximum diameter at abutment/implant<br>interface | ⌀4.0~⌀8.0 | | Minimum and Maximum length of abutment | 4.5~13mm | | Minimum and Maximum length of abutment post (length<br>above the abutment collar/gingival height) | 4~8mm | | Minimum wall thickness at abutment/implant interface | 0.4mm | | Minimum and Maximum abutment angle | 0~25° | Pre-Milled Blank Design Limitation for Patient-specific abutment: Ti Base consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM-designed zirconia superstructure (the second part of the two-piece abutment) that composes the final abutment. Pre-Milled Blank and Ti Base are provided non-sterile therefore must be sterilized after the cementation of the patient-specified superstructure. #### Raw material blanks - InCoris Zi (ZrO2) by Sirona Dental Systems GmbH, L size blanks, cleared under K123664. ● #### Cement - . RelyX Unicem 2Automix by 3M ESPE, cleared under K100756. {6}------------------------------------------------ Design Limitation for Zirconia superstructure: Image /page/6/Figure/2 description: The image shows a technical drawing of an abutment, along with a table outlining its design parameters and limits. The drawing includes dimensions such as a diameter of 5.0-8.0, a minimum thickness of 0.4, a cuff height of 0.5-5.0, and a post length of 4.0-6.0. The table specifies the minimum and maximum abutment angle as 0-15, the gingival cuff height as 0.5-5.0, the abutment post length as 4.0-6.0, the diameter at the abutment/implant interface as 5.0-8.0, and the minimum wall thickness at the abutment/implant interface as 0.4. SIMDA Abutment is a device that can only be sold, distributed, or used upon the order of an authorized healthcare provider, generally referred to as prescription (Rx) devices. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "SIMDA" in large, bold, blue letters. The letters are sans-serif and appear to be a uniform thickness. The word is presented against a white background, making the blue letters stand out prominently. The overall impression is clean and professional. #### Indication for Use SIMDA Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. | Compatible System | Implant Body<br>Diameter(mm) | Implant<br>Platform | |----------------------------------------------------------------------|-------------------------------------------------------------------|---------------------| | Osstem TS (K121995) | 3.5, 3.75 | Mini | | Osstem TS (K121995) | 3.75, 3.77, 4.2, 4.25, 4.4, 4.6, 4.63, 4.65, 4.9, 5.05, 5.08, 5.1 | Regular | | Straumann Bone Level<br>(only the Roxolid® implants<br>from K140878) | 3.3 | NC | | Straumann Bone Level<br>(only the Roxolid® implants<br>from K140878) | 4.1, 4.8 | RC | It is compatible with the following systems: All digitally designed abutments for use with SIMDA Abutments are intended to be sent to a SMIDA validated milling center for manufacture. #### Summary of Technological Characteristics The subject device and the primary predicate have the same intended use, similar technological characteristics, and are made of the same materials. The subject device and the primary predicate encompass the same range of physical dimensions, are packaged in similar materials, and are to be sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the primary predicate listed above. {8}------------------------------------------------ ### Non-clinical Testing #### MR Environment Condition Non-clinical worst-case MRI review was performed to evaluate the metallic SIMDA abutment in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque. Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalen ce included: - · Fatigue testing followed ISO 14801 and the FDA special controls guidance document. - · End User Steam Sterilization Test according to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010. - · Biocompatibility tests according to ISO 10993-1:2009. ISO 10993-5:2009. and ISO 10993-10:2010. Non-clinical test data was used to evaluate the proposed device's substantial equivalence compared to the primary predicate. The results of the above tests have demonstrated the substantial equivalence with the primary predicate. Non-clinical testing was conducted in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments'', and it consisted of testing finished assembled implant/abutment systems of the worstcase scenarios through fatigue testing. Dimensional analysis and reverse engineering of critical features of critical features and tolerances of the implant-to-abutment connection platform were performed on the OEM implant body, the OEM abutment, and the OEM abutment screw. Cross sectional images wre provided to demonstrate substantially equivalent compatibility. The testing aided implant to abutment compatibility and has established substantial equivalency of the proposed device with the predicate devices. Clinical testing was not necessary to establish substantial equivalency of the device. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the word "SIMDA" in a bold, sans-serif font. The letters are all capitalized and are a dark blue color. The word is centered and takes up most of the frame. ### Primary Predicate / Reference devices: The subject device is substantially equivalent to the following primary predicate and reference devices: - Primary Predicate - TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment (K220562) - - Reference devices - OSSTEM TS Fixture System (K121995) - - Straumann® Tapered Implant System (K140878) - - DD Solid Connect® CAD/CAM Abutments(K191111) - ### Comparison between Primary predicates #### Pre-Milled Blank | Feature | Proposed Device | Primary predicate | SE discussion | | | | | | | | | | | | | | | | |-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|---------------|--|--|--|--|--|--|--|--|--|--|--|--|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | SIMDA Abutment | TiGEN Abutment | = | | | | | | | | | | | | | | | | | Applicant | SIMDA Co., Ltd. | MegaGen Co., Ltd. | = | | | | | | | | | | | | | | | | | Part Name | Pre-Milled Blank | TiGEN Abutment, ZrGEN Abutment<br>and Scan Healing Abutment | = | | | | | | | | | | | | | | | | | 510(K) No. | K223663 | K220562 | = | | | | | | | | | | | | | | | | | Classification<br>Name | Endosseous Dental Implant Abutments<br>(872.3630) | Endosseous Dental Implant<br>Abutments (872.3630) | Identical | | | | | | | | | | | | | | | | | Product Code | NHA | NHA | Identical | | | | | | | | | | | | | | | | | Screw and<br>Abutment<br>Material | Ti-6Al-4V ELI<br>(ASTM F136) | Ti-6Al-4V ELI<br>(ASTM F136) | Identical | | | | | | | | | | | | | | | | | Indications<br>For Use | SIMDA Abutments are intended for use<br>with dental implants as a support for<br>single or multiple tooth prostheses in the<br>maxilla or mandible of a partially or<br>fully edentulous patient.<br><br>It is compatible with the following<br>systems:<br>Compatible System Implant Body<br>Diameter(mm) Implant<br>Platform Osstem TS (K121995) 3.5, 3.75 Mini 3.75, 3.77, 4.2, 4.25, 4.4,<br>4.6, 4.63, 4.65, 4.9, 5.05,<br>5.08, 5.1 Regular Straumann Bone Level<br>(only the Roxolid® implants<br>from K140878) 3.3 NC 4.1, 4.8 RC<br>All digitally designed abutments for use<br>with SIMDA Abutments are intended to<br>be sent to a SIMDA validated<br>milling center for manufacture. | | | | | | | | | | | | | | | | The TiGEN Abutment, ZrGEN<br>Abutment and Scan Healing<br>Abutment are intended for use on<br>endosseous dental<br>implants in the edentulous or partially<br>edentulous maxilla or mandible, as an<br>aid in prosthetic rehabilitation.<br>For TiGEN Abutment and ZrGEN<br>Abutment, all digitally designed<br>abutments for use with TiGEN<br>Abutment and<br>ZrGEN Abutment are intended to be<br>sent to a MegaGen-validated milling<br>center for manufacture. | The subject device is<br>substantially equivalent in<br>indications and design<br>principles to the primary<br>predicate device listed above.<br>Provided tables are comparing<br>the Indications for Use<br>Statements and the<br>technological characteristics of<br>the subject device, the primary<br>predicate device. The<br>Indications for Use Statement<br>(IFUS) for the subject device is<br>substantially equivalent in<br>intended use to the primary<br>predicate device. All are<br>intended for use with<br>endosseous dental implants in<br>the maxilla and mandible to<br>provide functional and esthetic<br>rehabilitation of the edentulous | {10}------------------------------------------------ ### SIN く | Feature | Proposed Device | Primary predicate | SE discussion | |------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | SIMDA Abutment | TiGEN Abutment | maxilla and mandible. Slight<br>differences in the language of<br>the subject device and primary<br>predicate is Indications for Use<br>statements do not affect the<br>intended use as an endosseous<br>dental implant abutment for<br>support of a prosthesis to restore<br>chewing function. The minor<br>differences between the subject<br>device and the primary<br>predicate device are related to<br>the compatible OEM implant<br>lines and the implant platform<br>diameter. | | Design Limits<br>for patient-<br>specific<br>abutment<br>(Min. ~ Max.) | Maximum Angulation : 0~25°<br>Maximum Cuff Height : 0.5~5mm<br>Minimum Diameter : Ø 4.0~ Ø 8.0mm<br>Minimum Thickness : 0.4mm<br>Minimum Post Height : 4~6mm | Standard type<br>Minimum wall thickness(mm): 0.47<br>Maximum Angulation : 30°<br>Minimum gingival collar height(mm) :<br>2.0<br>Minimum gingival collar height(mm) :<br>5.0<br>Minimum gingival collar(Ø) : 3.5,4.0,4.5<br>Maximum gingival collar(Ø) : 9.5, 11.5<br>Minimum post height : 4.0<br>Maximum post height : 6.0, 6.5<br>Octa level type<br>Minimum wall thickness(mm): 0.47<br>Maximum Angulation : 30°<br>Minimum gingival collar(Ø) : 4.0<br>Maximum gingival collar(Ø) : 9.5, 11.5<br>Minimum post height : 4.0<br>Maximum post height : 6.0 | The minor difference between<br>the two products in the design<br>parameters are as follow.<br>The minimum diameter of the<br>product compatible with the<br>subject device is larger than the<br>primary predicate device. The<br>diameter of the primary<br>predicate device is Ø3.5mm~<br>Ø11.5mm, while the subject<br>device can be designed from Ø<br>4.0mm up to Ø8.0mm. The<br>maximum angle of the product<br>compatible with the subject<br>device is smaller than the<br>primary predicate device. The<br>angle of the primary predicate<br>device is 30°, while the subject<br>device can be designed up to<br>25°.<br>The minimum thickness of the<br>primary predicate device is<br>0.47, while the subject device<br>can be designed up to 0.4.<br>The angle of the primary<br>predicate device is 30°, while<br>the subject device can be<br>designed up to 25°.<br>The cuff height of the primary<br>predicate device is 2.0mm~<br>5.0mm, while the subject device<br>can be designed from 0.5mm up<br>to 5.0mm.<br>The post height of the primary<br>predicate device is 4.0mm~<br>6.5mm, while the subject device<br>can be designed from 4.0mm up<br>to 6.0mm | | Feature | Proposed Device<br>SIMDA Abutment | Primary predicate<br>TiGEN Abutment | SE discussion | | | | | to 6.0mm. Even though there<br>are some minor differences in<br>dimensions, performance testing<br>demonstrated that the subject<br>device has substantially<br>equivalent fatigue performance. | | Surface<br>Treatment | None | None | - | | Sterile | steam sterilized before use | steam sterilized before use | - | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the word "SIMDA" in a sans-serif font. The letters are a dark blue color. The letters are evenly spaced and the word is centered in the image. The background is white. {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the word "SIMDA" in a sans-serif font. The letters are a dark blue color. The letters are evenly spaced and the word is centered in the image. The background is white. ### Ti Base | Feature | Proposed Device<br>SIMDA Abutment | Primary predicate<br>TiGEN Abutment | Reference Device<br>DD Prefab | SE discussion | |------------------------|---------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------|---------------| | Applicant | SIMDA Co., Ltd. | MegaGen Co., Ltd. | Dental Direkt GmbH | - | | Part Name | Ti-Base | TiGEN Abutment, ZrGEN Abutment<br>and Scan Healing Abutment | DD Ti-Base 2CUT | - | | 510(K) No. | K223663 | K220562 | K191111 | - | | Classification<br>Name | Endosseous Dental Implant Abutments<br>(872.3630) | Endosseous Dental Implant<br>Abutments (872.3630) | Endosseous Dental Implant<br>Abutments (872.3630) | Identical | | Product Code | NHA | NHA | NHA | Identical | | Material | Ti-6Al-4V ELI<br>(ASTM F136)<br>Zirconia | Ti-6Al-4V ELI<br>(ASTM F136)<br>Zirconia | Ti-6Al-4V ELI<br>(ASTM F136)<br>Zirconia | Identical | {13}------------------------------------------------ | Indications<br>For Use | SIMDA Abutments are intended for use<br>with dental implants as a support for<br>single or multiple tooth prostheses in the<br>maxilla or mandible of a partially or<br>fully edentulous patient.<br><br>It is compatible with the following<br>systems:<br>Compatible System Implant Body<br>Diameter(mm) Implant<br>Platform Osstem TS (K121995) 3.5, 3.75 Mini 3.75, 3.77, 4.2, 4.25, 4.4,<br>4.6, 4.63, 4.65, 4.9, 5.05,<br>5.08, 5.1 Regular Straumann Bone Level<br>(only the Roxolid® implants<br>from K140878) 3.3 NC 4.1, 4.8 RC All digitally designed abutments for use<br>with SIMDA Abutments are intended to<br>be sent to a SIMDA validated<br>milling center for manufacture. | | | | | | | | | | | | | | | | The TiGEN Abutment, ZrGEN<br>Abutment and Scan Healing<br>Abutment are intended for use on<br>endosseous dental implants in the<br>edentulous or partially edentulous<br>maxilla or mandible, as an aid in<br>prosthetic rehabilitation.<br>For TiGEN Abutment and ZrGEN<br>Abutment, all digitally designed<br>abutments for use with TiGEN<br>Abutment and<br>ZrGEN Abutment are intended to be<br>sent to a MegaGen-validated milling<br>center for manufacture. | DD Solid Connect® CAD/CAM<br>Abutments are used to support<br>prosthetic restorations in<br>combination with endosseous<br>dental implants in the upper<br>and/or lower jaw. DD Prefab<br>abutments, for the Zimmer<br>Biomet 3i Certain 3.4mm<br>implant bodies, and DD Ti-Base<br>2CUT abutments, for the<br>Altatech Camlog ScrewLine<br>3.3mm implant bodies, are<br>indicated for maxillary lateral<br>and mandibular central/lateral<br>incisors only. All digitally<br>designed custom abutments for<br>use with DD Solid Connect®<br>CAD/CAM Abutments are to be<br>sent to a Dental Direkt validated<br>milling center for manufacture. | The subject device is<br>substantially equivalent in<br>indications and design<br>principles to the primary<br>predicate device listed above.<br>Provided tables are comparing<br>the Indications for Use<br>Statements and the<br>technological characteristics of<br>the subject device, the primary<br>predicate device. The<br>Indications for Use Statement<br>(IFUS) for the subject device is<br>substantially equivalent in<br>intended use to the primary<br>predicate device. All are<br>intended for use with<br>endosseous dental implants in<br>the maxilla and mandible to<br>provide functional and esthetic<br>rehabilitation of the edentulous<br>maxilla and mandible. Slight<br>differences in the language of<br>the subject device and primary<br>predicate is Indications for Use<br>statements do not affect the<br>intended use as an endosseous<br>dental implant abutment for<br>support of a prosthesis to restore<br>chewing function. The minor<br>differences between the subject<br>device and the primary<br>predicate device are related to<br>the compatible OEM implant<br>lines and the implant platform<br>diameter. | 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{14}------------------------------------------------ | Titanium base | Angulation | 0 | 0 | Not identified | Idential | |------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Gingival collar | 3.8, 4.0, 4.5 | 2.2~6.0 | Not identified | While there are 3 types of<br>subject devices, 3.8, 4.0, and<br>4.5, primary predicate devices<br>have various diameters for<br>standard type, C-type, and Octa<br>type. | | | Post height | 3.5, 5.5 | 1.2~8.0 | Not identified | While there are 2 types of<br>subject devices, 3.5, and 5.5,<br>primary predicate devices have<br>various diameters for standard<br>type, C-type, and Octa type. | | | Thickness | 0.16~0.87 | 0.12~1.35 | Not identified | The thickness of the primary<br>predicate device is 0.12mm~<br>1.35mm, while the subject<br>device can be designed from<br>0.16mm up to 0.87mm. | | Design Limits<br>for Zirconia<br>top-half<br>(Min. ~ Max.) | - Post Angle (°): 0~15<br>- Cuff Height (mm): 0.5~5.0<br>-Post Length (mm): 4.0~6.0<br>-Diameter (Ø, mm): 5.0~8.0<br>-Thickness (mm): 0.4 | Minimum wall thickness (mm) : 0.5<br>Maximum angulation (°): 0<br>Minimum gingival collar (Ø) : 8<br>Maximum gingival collar (Ø): 10<br>Minimum Gingival collar height<br>(mm) : 2<br>Maximum Gingival collar height<br>(mm) : 5<br>Minimum post height (mm) : 7<br>Maximum post height (mm) : 15 | Minimum wall thickness (mm) :<br>0.5<br>Maximum angulation (°): 0~20<br>Minimum gingival collar (Ø) :<br>2.7<br>Maximum gingival collar (Ø) : 7<br>Minimum Gingival collar height<br>(mm) : 0.5<br>Maximum Gingival collar<br>height (mm) : 6<br>Minimum post height (mm) : 4<br>Maximum post height (mm) :<br>6.5 | | The minor difference between<br>the two products in the design<br>parameters are as follow.<br>The minimum diameter of the<br>product compatible with the<br>subject device is larger than the<br>primary predicate device. The<br>diameter of the primary<br>predicate device is Ø8mm~<br>Ø10mm, while the subject<br>device can be designed from Ø<br>5.0mm up to Ø8.0mm.<br>The angle of the reference<br>device is 0~20°, while the<br>subject device can be designed<br>up to 15°.<br>The minimum thickness of the<br>primary predicate device is 0.5,<br>while the subject device can be<br>designed up to 0.4 | | | | | | The cuff height of the primary<br>predicate device is 2.0mm~<br>5.0mm, while the subject device<br>can be designed from 0.5mm up<br>to 5.0mm.<br>The post height of the primary<br>predicate device is 7.0mm~<br>15mm, while the subject device<br>can be designed from 4.0mm up<br>to 6.0mm. | | | Prothesis<br>Attachment | Cement-retained, Screw-retained | Cement-retained, Screw-retained | Cement-retained, Screw-<br>retained | Identical | | | Surface<br>Treatment | None | None | None | - |…