(168 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.
It is compatible with the following systems:
Compatible System Implant Body Diameter(mm) Implant 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 (only the Roxolid® implants from K140878) 3.3 NC
Straumann Bone Level (only the Roxolid® implants 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.
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.
Pre-Milled Blank Design Limitation for Patient-specific abutment:
Design parameter (Patient-specific abutment) Subject System Design Limit
Minimum and Maximum Gingival (Cuff) Height 0.55mm⌀8.0
Minimum and Maximum diameter at abutment/implant interface ⌀4.0
Minimum and Maximum length of abutment 4.513mm8mm
Minimum and Maximum length of abutment post (length above the abutment collar/gingival height) 4
Minimum wall thickness at abutment/implant interface 0.4mm
Minimum and Maximum abutment angle 0~25°
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.
Design Limitation for Zirconia superstructure:
Design Limits for Zirconia top-half (Min. ~ Max.)
- Post Angle (°): 0~15
- Cuff Height (mm): 0.5
5.06.0
-Post Length (mm): 4.0
-Diameter (Ø, mm): 5.0~8.0
-Thickness (mm): 0.4
This FDA 510(k) summary (K223663) concerns a dental implant abutment, not an AI/ML medical device. Therefore, the information required to populate the fields related to AI/ML model performance, such as test set sample size, expert ground truth establishment, MRMC studies, and training set information, is not available in the provided document.
The document discusses the substantial equivalence of the SIMDA Abutment to existing predicate devices based on non-clinical testing for mechanical properties (fatigue), sterilization, and biocompatibility.
Here's an attempt to answer the relevant sections based on the provided text, and noting where information is not applicable or unavailable for an AI/ML device:
Acceptance Criteria and Device Performance for SIMDA Abutment
Since this is a non-AI/ML device (a dental abutment), the "acceptance criteria" are related to mechanical and biological performance rather than AI/ML algorithm metrics. The study described is a non-clinical study to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Parameter (Acceptance Criteria) | Reported Device Performance / Evaluation |
|---|---|---|
| Mechanical Performance | Fatigue testing (ISO 14801, FDA Special Controls Guidance) for worst-case scenarios of assembled implant/abutment systems. | "The results of the above tests have demonstrated the substantial equivalence with the primary predicate." (Implies meeting or exceeding predicate performance/safety). |
| Material Composition | Ti-6Al-4V ELI (ASTM F136) for Pre-Milled Blank and Ti-Base abutment. | "SIMDA Abutment is made of titanium alloy (Ti-6A1-4V ELI. ASTM F136)..." and "Material: Ti-6Al-4V ELI (ASTM F136) Zirconia" |
| Sterilization | End User Steam Sterilization Test (ISO 17665-1:2006, 17665-2:2009, ANSI/AAMI ST79:2010). | "The results of the above tests have demonstrated the substantial equivalence with the primary predicate." (Implies effective and compliant sterilization). "Pre-Milled Blank and Ti Base are provided non-sterile therefore must be sterilized after the cementation of the patient-specified superstructure." and "Sterile: steam sterilized before use" |
| Biocompatibility | Biocompatibility tests (ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010). | "The results of the above tests have demonstrated the substantial equivalence with the primary predicate." (Implies biocompatibility). |
| Dimensional Compatibility | Dimensional analysis and reverse engineering of critical features and tolerances of the implant-to-abutment connection platform (OEM implant body, abutment, screw). Cross-sectional images. | "Cross sectional images wre provided to demonstrate substantially equivalent compatibility." and "The testing aided implant to abutment compatibility and has established substantial equivalency of the proposed device with the predicate devices." |
| MR Environment Compatibility | Evaluation of metallic components in MR environment using scientific rationale and published literature per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." | "Non-clinical worst-case MRI review was performed to evaluate the metallic SIMDA abutment in the MRI environment using scientific rationale and published literature..." |
| Design Limits | Specific ranges for gingival cuff height, diameter at interface, length of abutment, post length, wall thickness, and abutment angle must fall within established safe/effective ranges relative to predicates. | The document provides design limits for "Patient-specific abutment" and "Zirconia superstructure" and compares them to predicate devices, discussing minor differences and concluding that performance testing demonstrated substantial equivalence. (e.g., "Even though there are some minor differences in dimensions, performance testing demonstrated that the subject device has substantially equivalent fatigue performance.") |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated in the document. Non-clinical mechanical fatigue testing typically uses a small number of samples (e.g., 5-10 per test condition) to demonstrate compliance with standards.
- Data Provenance: The tests are non-clinical (laboratory) studies. The manufacturer is SIMDA Co., Ltd. from REPUBLIC OF KOREA. The studies are prospective in the sense that they were designed and conducted to evaluate the device for this submission.
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 for this type of device/study. This section typically applies to AI/ML devices where human expert consensus is used to label medical images for ground truth. For a dental abutment, "ground truth" is established by engineering and material science standards, measurements, and physical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for resolving discrepancies in human expert labeling of data, which is not part of the non-clinical testing for a dental abutment.
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:
- No, this was not done. An MRMC study is performed for AI/ML devices to assess the impact of AI assistance on human reader performance. This is not applicable to a physical dental abutment. The document explicitly states: "Clinical testing was not necessary to establish substantial equivalency of the device."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This pertains to AI/ML algorithm performance in isolation. The product is a physical dental abutment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering and material science standards, physical measurements, and established performance criteria. Ground truth is implicitly defined by the referenced ISO standards (e.g., ISO 14801 for fatigue testing, ISO 17665-1 for sterilization) and the performance characteristics of the predicate devices. The "worst-case scenarios" were tested to ensure safety and effectiveness.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set."
Summary of what the study did prove:
The study proved that the SIMDA Abutment is substantially equivalent to a legally marketed predicate device (TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment K220562, and others) by demonstrating comparable:
- Intended Use
- Material composition
- Mechanical properties (through fatigue testing)
- Sterilization efficacy
- Biocompatibility
- Dimensional compatibility with specified implant systems
- Safety in an MR environment
The conclusion is based on non-clinical testing, which was deemed sufficient by the FDA to demonstrate substantial equivalence without the need for clinical studies.
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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.
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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
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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 BodyDiameter(mm) | ImplantPlatform |
|---|---|---|
| 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(only the Roxolid® implantsfrom K140878) | 3.3 | NC |
| Straumann Bone Level(only the Roxolid® implantsfrom 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
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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
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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 SystemDesign Limit |
|---|---|
| Minimum and Maximum Gingival (Cuff) Height | 0.5~5mm |
| Minimum and Maximum diameter at abutment/implantinterface | ⌀4.0~⌀8.0 |
| 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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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.
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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 BodyDiameter(mm) | ImplantPlatform |
|---|---|---|
| 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(only the Roxolid® implantsfrom K140878) | 3.3 | NC |
| Straumann Bone Level(only the Roxolid® implantsfrom 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.
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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 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.
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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
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 Abutmentand Scan Healing Abutment | = | |||||||||||||||
| 510(K) No. | K223663 | K220562 | = | |||||||||||||||
| 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: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 RCAll digitally designed abutments for usewith SIMDA Abutments are intended tobe sent to a SIMDA validatedmilling center for manufacture. | The TiGEN Abutment, ZrGENAbutment and Scan HealingAbutment are intended for use onendosseous dentalimplants in the edentulous or partiallyedentulous maxilla or mandible, as anaid in prosthetic rehabilitation.For TiGEN Abutment and ZrGENAbutment, all digitally designedabutments for use with TiGENAbutment andZrGEN Abutment are intended to besent to a MegaGen-validated millingcenter for manufacture. | 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 edentulous |
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SIN く
| Feature | Proposed Device | Primary predicate | SE discussion |
|---|---|---|---|
| SIMDA Abutment | TiGEN Abutment | maxilla 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. | |
| Design Limitsfor patient-specificabutment(Min. ~ Max.) | Maximum Angulation : 0 | Standard typeMinimum wall thickness(mm): 0.47Maximum Angulation : 30°Minimum gingival collar height(mm) :2.0Minimum gingival collar height(mm) :5.0Minimum gingival collar(Ø) : 3.5,4.0,4.5Maximum gingival collar(Ø) : 9.5, 11.5Minimum post height : 4.0Maximum post height : 6.0, 6.5Octa level typeMinimum wall thickness(mm): 0.47Maximum Angulation : 30°Minimum gingival collar(Ø) : 4.0Maximum gingival collar(Ø) : 9.5, 11.5Minimum post height : 4.0Maximum post height : 6.0 | The minor difference betweenthe two products in the designparameters are as follow.The minimum diameter of theproduct compatible with thesubject device is larger than theprimary predicate device. Thediameter of the primarypredicate device is Ø3.5mm~Ø11.5mm, while the subjectdevice can be designed from Ø4.0mm up to Ø8.0mm. Themaximum angle of the productcompatible with the subjectdevice is smaller than theprimary predicate device. Theangle of the primary predicatedevice is 30°, while the subjectdevice can be designed up to25°.The minimum thickness of theprimary predicate device is0.47, while the subject devicecan be designed up to 0.4.The angle of the primarypredicate device is 30°, whilethe subject device can bedesigned up to 25°.The cuff height of the primarypredicate device is 2.0mm~5.0mm, while the subject devicecan be designed from 0.5mm upto 5.0mm.The post height of the primarypredicate device is 4.0mm~6.5mm, while the subject devicecan be designed from 4.0mm upto 6.0mm |
| Feature | Proposed DeviceSIMDA Abutment | Primary predicateTiGEN Abutment | SE discussion |
| to 6.0mm. Even though thereare some minor differences indimensions, performance testingdemonstrated that the subjectdevice has substantiallyequivalent fatigue performance. | |||
| SurfaceTreatment | None | None | - |
| Sterile | steam sterilized before use | steam sterilized before use | - |
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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.
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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 DeviceSIMDA Abutment | Primary predicateTiGEN Abutment | Reference DeviceDD Prefab | SE discussion |
|---|---|---|---|---|
| Applicant | SIMDA Co., Ltd. | MegaGen Co., Ltd. | Dental Direkt GmbH | - |
| Part Name | Ti-Base | TiGEN Abutment, ZrGEN Abutmentand Scan Healing Abutment | DD Ti-Base 2CUT | - |
| 510(K) No. | K223663 | K220562 | K191111 | - |
| ClassificationName | Endosseous Dental Implant Abutments(872.3630) | Endosseous Dental ImplantAbutments (872.3630) | Endosseous Dental ImplantAbutments (872.3630) | Identical |
| Product Code | NHA | NHA | NHA | Identical |
| Material | Ti-6Al-4V ELI(ASTM F136)Zirconia | Ti-6Al-4V ELI(ASTM F136)Zirconia | Ti-6Al-4V ELI(ASTM F136)Zirconia | Identical |
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| 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 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 for usewith SIMDA Abutments are intended tobe sent to a SIMDA validatedmilling center for manufacture. | The TiGEN Abutment, ZrGENAbutment and Scan HealingAbutment are intended for use onendosseous dental implants in theedentulous or partially edentulousmaxilla or mandible, as an aid inprosthetic rehabilitation.For TiGEN Abutment and ZrGENAbutment, all digitally designedabutments for use with TiGENAbutment andZrGEN Abutment are intended to besent to a MegaGen-validated millingcenter for manufacture. | DD Solid Connect® CAD/CAMAbutments are used to supportprosthetic restorations incombination with endosseousdental implants in the upperand/or lower jaw. DD Prefababutments, for the ZimmerBiomet 3i Certain 3.4mmimplant bodies, and DD Ti-Base2CUT abutments, for theAltatech Camlog ScrewLine3.3mm implant bodies, areindicated for maxillary lateraland mandibular central/lateralincisors only. All digitallydesigned custom abutments foruse with DD Solid Connect®CAD/CAM Abutments are to besent to a Dental Direkt validatedmilling center for manufacture. | 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 platformdiameter. | |||||||||||||||
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| 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 ofsubject devices, 3.8, 4.0, and4.5, primary predicate deviceshave various diameters forstandard type, C-type, and Octatype. | |
| Post height | 3.5, 5.5 | 1.2~8.0 | Not identified | While there are 2 types ofsubject devices, 3.5, and 5.5,primary predicate devices havevarious diameters for standardtype, C-type, and Octa type. | |
| Thickness | 0.16~0.87 | 0.12~1.35 | Not identified | The thickness of the primarypredicate device is 0.12mm~1.35mm, while the subjectdevice can be designed from0.16mm up to 0.87mm. | |
| Design Limitsfor Zirconiatop-half(Min. ~ Max.) | - Post Angle (°): 0 | Minimum wall thickness (mm) : 0.5Maximum angulation (°): 0Minimum gingival collar (Ø) : 8Maximum gingival collar (Ø): 10Minimum Gingival collar height(mm) : 2Maximum Gingival collar height(mm) : 5Minimum post height (mm) : 7Maximum post height (mm) : 15 | Minimum wall thickness (mm) :0.5Maximum angulation (°): 0~20Minimum gingival collar (Ø) :2.7Maximum gingival collar (Ø) : 7Minimum Gingival collar height(mm) : 0.5Maximum Gingival collarheight (mm) : 6Minimum post height (mm) : 4Maximum post height (mm) :6.5 | The minor difference betweenthe two products in the designparameters are as follow.The minimum diameter of theproduct compatible with thesubject device is larger than theprimary predicate device. Thediameter of the primarypredicate device is Ø8mm~Ø10mm, while the subjectdevice can be designed from Ø5.0mm up to Ø8.0mm.The angle of the referencedevice is 0~20°, while thesubject device can be designedup to 15°.The minimum thickness of theprimary predicate device is 0.5,while the subject device can bedesigned up to 0.4 | |
| The cuff height of the primarypredicate device is 2.0mm~5.0mm, while the subject devicecan be designed from 0.5mm upto 5.0mm.The post height of the primarypredicate device is 7.0mm~15mm, while the subject devicecan be designed from 4.0mm upto 6.0mm. | |||||
| ProthesisAttachment | Cement-retained, Screw-retained | Cement-retained, Screw-retained | Cement-retained, Screw-retained | Identical | |
| SurfaceTreatment | None | None | None | - | |
| Sterile | steam sterilized before use | steam sterilized before use | steam sterilized before use | Identical |
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Substantial Equivalence Discussion
SIMDA Abutment incorporates the same material, indication, 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, and identification of reference predicate for compatible implant bodies. Both the predicate and subject devices are intent-specific abutments using CAD/CAM technology under the manufacturing control of the sponsor.
Any differences in technology characteristics are accompanied by information that 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.
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.)