SIMDA abutment

K232271 · Simda Co., Ltd. · NHA · Oct 26, 2023 · Dental

Device Facts

Record IDK232271
Device NameSIMDA abutment
ApplicantSimda Co., Ltd.
Product CodeNHA · Dental
Decision DateOct 26, 2023
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3630
Device ClassClass 2
AttributesTherapeutic

Intended 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.

Device Story

SIMDA Abutments are patient-specific dental implant abutments; used as support for single or multiple tooth prostheses. Device consists of Pre-Milled Blanks and Ti-Base abutments; manufactured from titanium alloy (Ti-6Al-4V ELI, ASTM F136). Workflow involves digital design of abutments by healthcare providers; files sent to SIMDA-validated milling center for production. Ti-Base supports CAD/CAM-designed zirconia superstructures. Components provided non-sterile; require sterilization after cementation of superstructure. Used in dental clinics; operated by dentists/prosthodontists. Output is a custom-milled abutment; provides functional and esthetic rehabilitation for edentulous patients.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including fatigue testing per ISO 14801, dimensional analysis, reverse engineering of implant-to-abutment connections, biocompatibility testing (ISO 10993), and steam sterilization validation (ISO 17665).

Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F136), Zirconia Oxide. Design: Pre-Milled Blanks and Ti-Base abutments. Dimensions: Cuff height 0.5-5mm, diameter 4.0-8.0mm, post height 4-8mm. Connectivity: CAD/CAM digital workflow for patient-specific design. Sterilization: Non-sterile, requires steam sterilization. Energy: None (mechanical).

Indications for Use

Indicated for use with dental implants as support for single or multiple tooth prostheses in maxilla or mandible of partially or fully edentulous patients.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Simda Co., Ltd. Cha Young Woo Regulatory Affairs Manager 156-4, Gamjeon-dong Busan, Sasang-gu REPUBLIC OF KOREA Re: K232271 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: July 28, 2023 Received: July 31, 2023 Dear Cha Young Woo: 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}------------------------------------------------ For comprehensive regulatory information about medical devices and radiation-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) K232271 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 | |-------------------------------------------------------|------------------------------|---------------------| | Dentium SuperLine<br>(K160965) | 3.6, 4.0, 4.5, 5.0, 6.0 | Regular | | Megagen AnyRidge®<br>(K140091) | 3.5, 4.0, 4.5, 5.0 | Regular | | Nobel Active 3.0<br>(K102436) | 3.0 | 3.0 | | Nobel Active Internal<br>Connection Implant (K071370) | 3.5 | NP | | Nobel Active Wide platform<br>(K133731) | 5.5 | WP | | Screw Vent® and Tapered<br>Screw Vent® (K013227) | 3.7, 4.1 | 3.5 | | | 4.7 | 4.5 | | | 6.0 | 5.7 | 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 style="font-size: 12px;"> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-size: 12px;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> | ### 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}------------------------------------------------ ### K 232271 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: | 10/25/2023 | | Subject Device | | | Trade Name: | SIMDA Abutment | | Common Name: | Abutment, Implant, Dental, Endosseous | | Classification Name | Endosseous dental implant abutment | | Product Code: | NHA | | Panel: | Dental | 21 CFR 872.3630 Class II ### Primary Predicate Device Class: Regulation Number: | Trade Name: | |----------------------| | Common Name: | | Classification Name: | | Product Code: | | Panel: | | Regulation Number: | | Device Class: | SIMDA Abutment (K223663) Abutment, Implant, Dental, Endosseous Endosseous dental implant abutment NHA Dental 21 CFR 872.3630 Class II ### Reference Device Trade Name: Common Name: Classification Name Product Code: Panel: Regulation Number: Device Class: Dentium Company Limited Implantium (K160965) by Dentium Co., Ltd. Abutment, Implant, Dental, Endosseous Endosseous dental implant abutment NHA Dental 21 CFR 872.3630 Class II {5}------------------------------------------------ # SIMD | Trade Name: | Xpeed AnyRidge Internal Implant System (K140091) by<br>MegaGen Implant Co., Ltd. | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Abutment, Implant, Dental, Endosseous | | Classification Name | Endosseous dental implant abutment | | Product Code: | NHA | | Panel: | Dental | | Regulation Number: | 21 CFR 872.3630 | | Device Class: | Class II | | Trade Name: | Nobelactive 3.0 (K102436) By Nobel Biocare<br>Nobelactive Internal Connection Implant (K071370) By Nobel<br>Biocare<br>Nobelactive Wide Platform (Wp) (K133731) By Nobel Biocare | | Common Name: | Abutment, Implant, Dental, Endosseous | | Classification Name | Endosseous dental implant abutment | | Product Code: | NHA | | Panel: | Dental | | Regulation Number: | 21 CFR 872.3630 | | Device Class: | Class II | | Trade Name: | Screw Vent® and Tapered Screw Vent® (K013227) by Sulzer<br>Dental Inc. | | Common Name: | Abutment, Implant, Dental, Endosseous | | Classification Name | Endosseous dental implant abutment | | Product Code: | NHA | | Panel: | Dental | | Regulation Number: | 21 CFR 872.3630 | | Device Class: | Class II | | Trade Name: | Nobel Active Wide Platform (K133731) by Sulzer<br>Dental Inc. | | Common Name: | Abutment, Implant, Dental, Endosseous | | Classification Name | Endosseous dental implant abutment | | Product Code: | NHA | | Panel: | Dental | | Regulation Number: | 21 CFR 872.3630 | | Device Class: | Class II | {6}------------------------------------------------ Trade Name: ### INCORIS ZI (K123664) Common Name: Classification Name Product Code: Panel: Regulation Number: Device Class: Powder, porcelain Porcelain powder of clinical use EIH Dental 21 CFR 872.6660 Class II Trade Name: Malta, 3M ESPE AG Dental Products (K100756) Common Name: Classification Name Product Code: Panel: Regulation Number: Device Class: Self adhesive cement Dental cement other zinc oxide-eugenol EMA Dental 21 CFR 872.3275 Class II {7}------------------------------------------------ ### Device Description SIMDA Abutment is made of titanium alloy (Ti-6Al-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 | Ø4.0~Ø8.0 | | 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. {8}------------------------------------------------ Image /page/8/Figure/1 description: The image shows a technical drawing of an abutment, including a top-down view and a cross-sectional side view with labeled dimensions. The drawing specifies 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. A table below the drawing lists design parameters and their limits, including an abutment angle of 0-15, a gingival cuff height of 0.5-5.0, an abutment post length of 4.0-6.0, a diameter at the abutment/implant interface of 5.0-8.0, and a wall thickness at the abutment/implant interface of 0.4. ### Design Limitation for Zirconia superstructure: 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. {9}------------------------------------------------ ### 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 Diameter(mm) | Implant Platform | |----------------------------------------------------|---------------------------|------------------| | Dentium SuperLine<br>(K160965) | 3.6, 4.0, 4.5, 5.0, 6.0 | Regular | | Megagen AnyRidge®<br>(K140091) | 3.5, 4.0, 4.5, 5.0 | Regular | | Nobel Active 3.0<br>(K102436) | 3.0 | 3.0 | | Nobel Active Internal Connection Implant (K071370) | 3.5 | NP | | Nobel Active Wide platform (K133731) | 5.5 | WP | | Screw Vent® and Tapered Screw Vent® (K013227) | 3.7, 4.1 | 3.5 | | | 4.7 | 4.5 | | | 6.0 | 5.7 | 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. {10}------------------------------------------------ ### 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 were 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 device. Clinical testing was not necessary to establish substantial equivalency of the device. {11}------------------------------------------------ ### Primary Predicate / Reference devices: The subject device is substantially equivalent to the following primary predicate and reference devices: - Primary Predicate - SIMDA Abutment (K223663) - - Reference devices - Dentium SuperLine (K160965) - - Megagen AnyRidge® (K140091) - - -Nobel Active 3.0 (K102436) - -Nobel Active Internal Connection Implant (K071370) - Nobel Active Wide Platform (WP) (K133731) - - Screw Vent® and Tapered Screw Vent® (K013227) - ### Comparison between Primary predicates ### Pre-Milled Blank | Feature | Proposed Device<br>SIMDA Abutment | Primary predicate<br>SIMDA Abutment | SE discussion | | | | | | | | | | |-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant | SIMDA Co., Ltd. | SIMDA Co., Ltd. | = | | | | | | | | | | | Part Name | Pre-Milled Blank | Pre-Milled Blank | = | | | | | | | | | | | 510(K) No. | - | K223663 | = | | | | | | | | | | | 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>It is compatible with the following<br>systems: | SIMDA Abutments are intended for<br>use with dental implants as a support<br>for single or multiple tooth prostheses<br>in the maxilla or mandible of a<br>partially or fully edentulous patient.<br>It is compatible with the following<br>systems: | 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 | | | | | | | | | | | | | Compatible System Implant Body<br>Diameter(mm) Implant<br>Platform Osstem TS (K121995) 3.5, 3.75<br>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 Mini<br>Regular Straumann Bone Level<br>(only the Roxolid® implants<br>from K140878) 3.3<br>4.1, 4.8 NC<br>RC | | | | | | | | | | 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 | {12}------------------------------------------------ # SIMI 14 | Feature | Proposed Device<br>SIMDA Abutment | | | Primary predicate<br>SIMDA Abutment | SE discussion | |------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Compatible System | Implant Body<br>Diameter(mm) | Implant<br>Platform | | | | | Dentium SuperLine<br>(K160965) | 3.6, 4.0, 4.5, 5.0, 6.0 | Regular | All digitally designed abutments for<br>use with SIMDA Abutments are<br>intended to be sent to a SMIDA<br>validated milling center for<br>manufacture. | 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 and the new<br>compatibilities have been<br>verified via reverse engineering<br>and performance testing. | | | Megagen AnyRidge®<br>(K140091) | 3.5, 4.0, 4.5, 5.0 | Regular | | | | | Nobel Active 3.0<br>(K102436) | 3.0 | 3.0 | | | | | Nobel Active Internal<br>Connection Implant (K071370) | 3.5 | NP | | | | | Nobel Active Wide platform<br>(K133731) | 4.3, 5.0 | RP | | | | | | 5.5 | WP | | | | | | 3.7, 4.1 | 3.5 | | | | | Screw Vent® and Tapered<br>Screw Vent® (K013227) | 4.7 | 4.5 | | | | | | 6.0 | 5.7 | | | | | All digitally designed abutments for use<br>with SIMDA Abutments are intended to<br>be sent to a SMIDA validated milling<br>center for manufacture. | | | | | | Dimension of<br>Pre-milled<br>Blank | Total length (mm) : 28.05, 28.25, 28.37, 28.4,<br>28.45, 28.6, 28.65, 28.9, 28.92<br>Diameter (mm) : 10, 14 | | | Total length (mm) : 27.88, 28.92, 30.8,<br>28.9, 28.92<br>Diameter (mm) : 10, 14 | The minor difference between<br>the two products in the total<br>length are as follow.<br>The total length of predicate<br>device is 27.88, 28.92, 30.8, 28.9,<br>28.92, while the subject device is<br>28.05, 28.25, 28.37, 28.4, 28.45,<br>28.6, 28.65, 28.9, 28.92 . | | 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 : 0.39~0.55mm<br>Minimum Post Height : 4~6mm | | | 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 | The minor difference between<br>the two products in the design<br>parameters are as follow.<br>The minimum thickness of the<br>primary predicate device is 0.4,<br>while the subject device can be<br>designed up to 0.39~0.55. This<br>change in technological<br>characteristics was evaluated as<br>part of the performance testing<br>and was determined to not<br>impact the performance of the<br>device." | | Surface<br>Treatment | None | | | None | - | | Sterile | Non-sterile | | | Non-sterile | - | {13}------------------------------------------------ # SIM く ### Ti Base | Feature | Proposed Device<br>SIMDA Abutment | Primary predicate<br>SIMDA Abutment | SE discussion | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|---------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant | SIMDA Co., Ltd. | SIMDA Co., Ltd. | - | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Part Name | Ti-Base | Ti-Base | - | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 510(K) No. | - | K223663 | - | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Classification<br>Name | Endosseous Dental Implant Abutments<br>(872.3630) | Endosseous Dental Implant<br>Abutments (872.3630) | Identical | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Product Code | NHA | NHA | Identical | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Material | Ti-6Al-4V ELI<br>(ASTM F136)<br>Zirconia Oxide | Ti-6Al-4V ELI<br>(ASTM F136)<br>Zirconia Oxide | 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>It is compatible with the following<br>systems:<br>Compatible System Implant Body<br>Diameter(mm) Implant<br>Platform Dentium SuperLine<br>(K160965) 3.6, 4.0, 4.5, 5.0, 6.0 Regular Megagen AnyRidge®<br>(K140091) 3.5, 4.0…
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