(87 days)
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.
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.
This FDA 510(k) summary describes a dental device, the SIMDA Abutment. However, it does not include information that directly addresses the specific questions you've asked about acceptance criteria and a study proving a device meets them, particularly for an AI/ML powered device.
Here's why and what information is provided:
The document is a premarket notification for a Class II medical device, specifically dental implant abutments. These are physical components used in dental restorations, not an AI/ML powered diagnostic or therapeutic device. Therefore, the concepts of "acceptance criteria for an AI model," "test set," "ground truth," "MRMC studies," "effect size of human readers with AI assistance," or "standalone algorithm performance" are not applicable to this submission.
The "studies" mentioned are non-clinical (mechanical, biological) tests demonstrating the physical safety and performance of the abutments and their compatibility with existing dental implant systems.
Here's a breakdown of the relevant information provided, framed as closely as possible to your request, but acknowledging the device type:
Device: SIMDA Abutments (K232271)
Device Type: Endosseous Dental Implant Abutment (physical medical device, not AI/ML powered)
1. A table of acceptance criteria and the reported device performance
The document sets design limits and then demonstrates conformity through non-clinical testing. The "acceptance criteria" here are rather design specifications and performance standards for dental abutments.
| Acceptance Criteria (Design Parameters/Limitations) | Reported Device Performance (Demonstrated through testing) |
|---|---|
| Pre-Milled Blank (for Patient-specific abutment): | |
| - Minimum and Maximum Gingival (Cuff) Height: 0.5~5mm | "The minor difference between the two products in the design parameters [...] was evaluated as part of the performance testing and was determined to not impact the performance of the device." - Implies device meets these parameters and performs acceptably. |
| - Minimum and Maximum diameter at abutment/implant interface: Ø4.0~Ø8.0 | |
| - Minimum and Maximum length of abutment: 4.5~13mm | |
| - Minimum and Maximum length of abutment post (length above the abutment collar/gingival height): 4~8mm | |
| - Minimum wall thickness at abutment/implant interface: 0.4mm (Predicate: 0.4mm, Proposed: 0.39~0.55mm) | "This change in technological characteristics [minimum thickness] was evaluated as part of the performance testing and was determined to not impact the performance of the device." - Indicates the slightly wider range for the proposed device (0.39-0.55mm) still met performance requirements. |
| - Minimum and Maximum abutment angle: 0~25° | |
| Ti-Base (for Zirconia top-half): | |
| - Post Angle (°): 0~15 | Identical to predicate. Non-clinical testing results "demonstrated the substantial equivalence with the primary predicate." |
| - Cuff Height (mm): 0.5~5.0 | |
| - Post Length (mm): 4.0~6.0 | |
| - Diameter (Ø, mm): 5.0~8.0 | |
| - Thickness (mm): 0.4 | |
| General Performance: | |
| - Fatigue Resistance: Must meet ISO 14801 and FDA special controls guidance. | Fatigue testing followed ISO 14801 and the FDA special controls guidance document. Results "demonstrated the substantial equivalence with the primary predicate." |
| - Sterilization Efficacy: Must meet ISO 17665-1:2006, 17665-2:2009, ANSI/AAMI ST79:2010. | End User Steam Sterilization Test according to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010. Results "demonstrated the substantial equivalence with the primary predicate." |
| - Biocompatibility: Must meet ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010. | Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010. Results "demonstrated the substantial equivalence with the primary predicate." |
| - MRI Safety: Must address magnetically induced displacement force and torque (per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment"). | "Non-clinical worst-case MRI review was performed... using scientific rationale and published literature... Rationale addressed parameters per the FDA guidance... including magnetically induced displacement force and torque." - Implies the device is deemed safe in the MR environment based on this review. |
| - Compatibility with OEM Implant Systems: Precision implant/abutment interface. | Dimensional analysis and reverse engineering of critical features... 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. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided. For physical tests (fatigue, biocompatibility, sterilization), sample sizes would typically be determined by the relevant ISO standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. "Ground truth" in the context of AI/ML is not relevant here. The "truth" is established by physical measurement, adherence to material standards, and documented mechanical performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically for subjective assessments, whereas these are objective physical tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a physical dental device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical dental device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For physical tests, the "ground truth" is defined by the ISO standards and FDA guidance documents to which the device is tested. This includes established methods for fatigue testing, biocompatibility evaluation, and sterilization efficacy. For compatibility, it's about precise dimensional matching and mechanical fit to existing OEM implant systems.
8. The sample size for the training set
- Not applicable. This is a physical dental device, not an AI/ML powered device that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
In summary, this document is for a traditional medical device (dental abutments), and thus the questions formulated for an AI/ML device do not directly apply. The acceptance criteria are based on established engineering and materials standards, and performance is demonstrated through non-clinical laboratory testing rather than clinical or observational studies on diagnostic performance.
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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.
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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.
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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
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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 BodyDiameter(mm) | ImplantPlatform |
|---|---|---|
| Dentium SuperLine(K160965) | 3.6, 4.0, 4.5, 5.0, 6.0 | Regular |
| Megagen AnyRidge®(K140091) | 3.5, 4.0, 4.5, 5.0 | Regular |
| Nobel Active 3.0(K102436) | 3.0 | 3.0 |
| Nobel Active InternalConnection Implant (K071370) | 3.5 | NP |
| Nobel Active Wide platform(K133731) | 5.5 | WP |
| Screw Vent® and TaperedScrew 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
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SIMD
| Trade Name: | Xpeed AnyRidge Internal Implant System (K140091) byMegaGen 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 BiocareNobelactive Internal Connection Implant (K071370) By NobelBiocareNobelactive 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 SulzerDental 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 SulzerDental 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 |
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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
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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 SystemDesign Limit |
|---|---|
| Minimum and Maximum Gingival (Cuff) Height | 0.5~5mm |
| Minimum and Maximum diameter at abutment/implantinterface | Ø4.0~Ø8.0 |
| Minimum and Maximum length of abutment | 4.5~13mm |
| Minimum and Maximum length of abutment post (lengthabove 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.
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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.
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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(K160965) | 3.6, 4.0, 4.5, 5.0, 6.0 | Regular |
| Megagen AnyRidge®(K140091) | 3.5, 4.0, 4.5, 5.0 | Regular |
| Nobel Active 3.0(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.
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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.
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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
Comparison between Primary predicates
Pre-Milled Blank
| Feature | Proposed DeviceSIMDA Abutment | Primary predicateSIMDA Abutment | SE discussion | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Applicant | SIMDA Co., Ltd. | SIMDA Co., Ltd. | = | |||||||||
| Part Name | Pre-Milled Blank | Pre-Milled Blank | = | |||||||||
| 510(K) No. | - | K223663 | = | |||||||||
| ClassificationName | Endosseous Dental Implant Abutments(872.3630) | Endosseous Dental ImplantAbutments (872.3630) | Identical | |||||||||
| Product Code | NHA | NHA | Identical | |||||||||
| Screw andAbutmentMaterial | Ti-6Al-4V ELI(ASTM F136) | Ti-6Al-4V ELI(ASTM F136) | Identical | |||||||||
| IndicationsFor Use | SIMDA Abutments are intended for usewith dental implants as a support forsingle or multiple tooth prostheses in themaxilla or mandible of a partially orfully edentulous patient.It is compatible with the followingsystems: | SIMDA Abutments are intended foruse with dental implants as a supportfor single or multiple tooth prosthesesin the maxilla or mandible of apartially or fully edentulous patient.It is compatible with the followingsystems: | The subject device issubstantially equivalent inindications and designprinciples to the primarypredicate device listed above.Provided tables are comparingthe Indications for UseStatements and the | |||||||||
| Compatible System Implant BodyDiameter(mm) ImplantPlatform Osstem TS (K121995) 3.5, 3.753.75, 3.77, 4.2, 4.25, 4.4,4.6, 4.63, 4.65, 4.9, 5.05,5.08, 5.1 MiniRegular Straumann Bone Level(only the Roxolid® implantsfrom K140878) 3.34.1, 4.8 NCRC | technological characteristics ofthe subject device, the primarypredicate device. TheIndications for Use Statement(IFUS) for the subject device issubstantially equivalent inintended use to the primarypredicate device. All are |
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SIMI 14
| Feature | Proposed DeviceSIMDA Abutment | Primary predicateSIMDA Abutment | SE discussion | ||
|---|---|---|---|---|---|
| Compatible System | Implant BodyDiameter(mm) | ImplantPlatform | |||
| Dentium SuperLine(K160965) | 3.6, 4.0, 4.5, 5.0, 6.0 | Regular | All digitally designed abutments foruse with SIMDA Abutments areintended to be sent to a SMIDAvalidated milling center formanufacture. | intended for use withendosseous dental implants inthe maxilla and mandible toprovide functional and estheticrehabilitation of the edentulousmaxilla and mandible. Slightdifferences in the language ofthe subject device and primarypredicate is Indications for Usestatements do not affect theintended use as an endosseousdental implant abutment forsupport of a prosthesis to restorechewing function. The minordifferences between the subjectdevice and the primarypredicate device are related tothe compatible OEM implantlines and the implant platformdiameter and the newcompatibilities have beenverified via reverse engineeringand performance testing. | |
| Megagen AnyRidge®(K140091) | 3.5, 4.0, 4.5, 5.0 | Regular | |||
| Nobel Active 3.0(K102436) | 3.0 | 3.0 | |||
| Nobel Active InternalConnection Implant (K071370) | 3.5 | NP | |||
| Nobel Active Wide platform(K133731) | 4.3, 5.0 | RP | |||
| 5.5 | WP | ||||
| 3.7, 4.1 | 3.5 | ||||
| Screw Vent® and TaperedScrew Vent® (K013227) | 4.7 | 4.5 | |||
| 6.0 | 5.7 | ||||
| All digitally designed abutments for usewith SIMDA Abutments are intended tobe sent to a SMIDA validated millingcenter for manufacture. | |||||
| Dimension ofPre-milledBlank | Total length (mm) : 28.05, 28.25, 28.37, 28.4,28.45, 28.6, 28.65, 28.9, 28.92Diameter (mm) : 10, 14 | Total length (mm) : 27.88, 28.92, 30.8,28.9, 28.92Diameter (mm) : 10, 14 | The minor difference betweenthe two products in the totallength are as follow.The total length of predicatedevice is 27.88, 28.92, 30.8, 28.9,28.92, while the subject device is28.05, 28.25, 28.37, 28.4, 28.45,28.6, 28.65, 28.9, 28.92 . | ||
| Design Limitsfor patient-specificabutment(Min. ~ Max.) | Maximum Angulation : 0 | Maximum Angulation : 0 | The minor difference betweenthe two products in the designparameters are as follow.The minimum thickness of theprimary predicate device is 0.4,while the subject device can bedesigned up to 0.39~0.55. Thischange in technologicalcharacteristics was evaluated aspart of the performance testingand was determined to notimpact the performance of thedevice." | ||
| SurfaceTreatment | None | None | - | ||
| Sterile | Non-sterile | Non-sterile | - |
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SIM く
Ti Base
| Feature | Proposed DeviceSIMDA Abutment | Primary predicateSIMDA Abutment | SE discussion | |||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Applicant | SIMDA Co., Ltd. | SIMDA Co., Ltd. | - | |||||||||||||||||||||||||||||||||||||||||||||
| Part Name | Ti-Base | Ti-Base | - | |||||||||||||||||||||||||||||||||||||||||||||
| 510(K) No. | - | K223663 | - | |||||||||||||||||||||||||||||||||||||||||||||
| ClassificationName | Endosseous Dental Implant Abutments(872.3630) | Endosseous Dental ImplantAbutments (872.3630) | Identical | |||||||||||||||||||||||||||||||||||||||||||||
| Product Code | NHA | NHA | Identical | |||||||||||||||||||||||||||||||||||||||||||||
| Material | Ti-6Al-4V ELI(ASTM F136)Zirconia Oxide | Ti-6Al-4V ELI(ASTM F136)Zirconia Oxide | Identical | |||||||||||||||||||||||||||||||||||||||||||||
| IndicationsFor Use | SIMDA Abutments are intended for usewith dental implants as a support forsingle or multiple tooth prostheses in themaxilla or mandible of a partially orfully edentulous patient.It is compatible with the followingsystems:Compatible System Implant BodyDiameter(mm) ImplantPlatform Dentium SuperLine(K160965) 3.6, 4.0, 4.5, 5.0, 6.0 Regular Megagen AnyRidge®(K140091) 3.5, 4.0, 4.5, 5.0 Regular Nobel Active 3.0(K102436) 3.0 3.0 Nobel Active InternalConnection Implant (K071370) 3.5 NP Nobel Active Wide platform(K133731) 4.3, 5.0 RP 5.5 WP Screw Vent® and TaperedScrew Vent® (K013227) 3.7, 4.1 3.5 4.7 4.5 6.0 5.7 All digitally designed abutments for usewith SIMDA Abutments are intended tobe sent to a SIMDA validated millingcenter for manufacture. | SIMDA Abutments are intended foruse with dental implants as a supportfor single or multiple tooth prosthesesin the maxilla or mandible of apartially or fully edentulous patient.It is compatible with the followingsystems:Compatible System Implant BodyDiameter(mm) ImplantPlatform Osstem TS (K121995) 3.5, 3.75 Mini 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(only the Roxolid® implantsfrom K140878) 3.3 NC 4.1, 4.8 RC All digitally designed abutments foruse with SIMDA Abutments areintended to be sent to a SIMDAvalidated milling center formanufacture. | The subject device issubstantially equivalent inindications and designprinciples to the primarypredicate device listed above.Provided tables are comparingthe Indications for UseStatements and thetechnological characteristics ofthe subject device, the primarypredicate device. TheIndications for Use Statement(IFUS) for the subject device issubstantially equivalent inintended use to the primarypredicate device. All areintended for use withendosseous dental implants inthe maxilla and mandible toprovide functional and estheticrehabilitation of the edentulousmaxilla and mandible. Slightdifferences in the language ofthe subject device and primarypredicate is Indications for Usestatements do not affect theintended use as an endosseousdental implant abutment forsupport of a prosthesis to restorechewing function. The minordifferences between the subjectdevice and the primarypredicate device are related tothe compatible OEM implantlines and the implant platform |
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| Feature | Proposed DeviceSIMDA Abutment | Primary predicateSIMDA Abutment | SE discussion | |
|---|---|---|---|---|
| Titanium base | Angulation | 0 | 0 | Idential |
| Gingival collar | 3.5, 3.8, 4.0, 4.3,4.5, 5.0, 6.5 | 3.8, 4.0, 4.5 | The minor difference betweenthe two products in the gingivalcollar are as follow.The gingival collar of predicatedevice is 3.8, 4.0, 4.5, while thesubject device is 3.5, 3.8, 4.0,4.3, 4.5, 5.0, 6.5. | |
| Post height | 3.5, 5.5 | 3.5, 5.5 | Idential | |
| Thickness | 0.16~0.87 | 0.16~0.87 | Idential | |
| Design Limitsfor Zirconiatop-half(Min. ~ Max.) | - Post Angle (°): 0 | - Post Angle (°): 0 | Idential | |
| ProthesisAttachment | Cement-retained, Screw-retained | Cement-retained, Screw-retained | Identical | |
| SurfaceTreatment | None | None | ||
| Sterile | Non-sterile | Non-sterile | Identical |
Substantial Equivalence Discussion
SIMDA Abutment incorporates the same material, indications for use, dimension, design, abutment seat, screw seat, anatomical site, connection, type of retention and technological characteristics as the primary predicate.
The Indications for Use of the subject and primary predicate are identical other than the compatible implant bodies. This difference is mitigated by fatigue testing, reverse engineering, dimensional analysis, and identification of reference predicate for compatible implant bodies. Both the predicate and subject devices are intended to be milled into patient-specific abutments using CAD/CAM technology under the manufacturing control of the sponsor.
Any differences in technology characteristics are accompanied by information that demonstrated the device is substantially equivalent as the predicate and do not raise different questions of safety and effectiveness than the predicate.
SIMDA Abutments are compatible with reference devices (K121995 and K140878). Each SIMDA Abutment platform has a precision implant/abutment interface corresponding to the implant system predicate for that platform.
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Conclusion
SIMDA Abutments constitute a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its primary predicate. Therefore, SIMDA Abutment and its predicate are substantially equivalent.
§ 872.3630 Endosseous dental implant abutment.
(a)
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.(b)
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.)