(168 days)
No
The summary describes a physical dental abutment and its components, materials, and testing. There is no mention of software, algorithms, or any functionality that would suggest the use of AI or ML. The "digitally designed abutments" are sent to a milling center, indicating a CAD/CAM process, not an AI/ML-driven design process.
No.
The device is an abutment for dental implants, intended to support prostheses for cosmetic and functional restoration of missing teeth, not to treat a disease or medical condition.
No
The device description indicates that SIMDA Abutments are used as a support for single or multiple tooth prostheses in dental implant procedures, making them a restorative device rather than one designed for diagnosis.
No
The device description clearly states it is made of titanium alloy and consists of physical components (Pre-Milled Blank and Ti-Base abutment). It also mentions manufacturing processes like milling and cementation, which are hardware-related.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the SIMDA Abutments are for use with dental implants as a support for dental prostheses in the mouth (maxilla or mandible). This is a direct medical device used within the body for structural support.
- Device Description: The description details the materials (titanium alloy, zirconia) and the physical components of the abutment, which are designed to be physically placed in the mouth and connect to a dental implant.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided text contains no mention of analyzing biological samples or providing diagnostic information.
The device described is a dental prosthetic component, specifically a dental implant abutment, which is a type of medical device used for structural support in dental restorations.
N/A
Intended Use / Indications 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
NHA
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.
Pre-Milled Blank Design Limitation for Patient-specific abutment:
| Design parameter (Patient-specific abutment) | Subject System Design Limit |
|---|---|
| Minimum and Maximum Gingival (Cuff) Height | 0.5~5mm |
| Minimum and Maximum diameter at abutment/implant interface | ⌀4.0~⌀8.0 |
| 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 |
| 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:
- Post Angle (°): 0~15
- 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla or mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
authorized healthcare provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 equivalence 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.
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.)
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
SIMDA Co., Ltd. Young Woo Cha Regulatory Affairs Manager 156-4, Gamjeon-dong Busan, Sasang-gu REPUBLIC OF KOREA
Re: K223663
Trade/Device Name: SIMDA Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 26, 2023 Received: April 26, 2023
Dear Young Woo Cha:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223663
Device Name SIMDA Abutments
Indications for Use (Describe)
SIMDA Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
It is compatible with the following systems:
| Compatible System | Implant Body
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.
| 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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3
K 223663 510(k) Summary
Applicant
| Name: | SIMDA Co., Ltd. |
|---|---|
| Address: | 156-4, Gamjeon-dong, Sasang-gu, Busan, South Korea |
| Phone: | +82 70 4256 2855 |
| Contact: | Young Woo, Cha |
| Email: | Email: chassi0406@gmail.com |
| Date Prepared: | 05/23/2023 |
SIMDA Abutment Dental implant abutment
21 CFR 872.3630
NHA Dental
Class II
Endosseous dental implant abutment
Subject Device
Primary Predicate
| Trade Name: | TiGEN Abutment, ZrGEN Abutment and Scan Healing |
|---|---|
| Common Name: | Abutment (K220562) |
| Classification Name | Endosseous dental implant abutment Abutment |
| Product Code: | NHA |
| Panel: | Dental |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | Class II |
Reference Device
Trade Name:
OSSTEM TS Fixture System, OSSTEM Implant Co., Ltd. (K121995)
Common Name: Classification Name Product Code: Panel: Regulation Number: Device Class:
Dental implant abutment Endosseous dental implant abutment DZE, NHA Dental 21 CFR 872.3640 Class II
4
Image /page/4/Picture/0 description: The image shows the word "SIMDA" in large, bold, blue letters. The letters are sans-serif and appear to be a uniform thickness. The word is centered and takes up most of the frame. The background is plain white.
Trade Name:
Straumann® Bone Level Tapered Implants (K140878)
Common Name: Classification Name Product Code: Panel: Regulation Number: Device Class:
Dental implant abutment Endosseous dental implant abutment NHA Dental 21 CFR 872.3630 Class II
Trade Name: Common Name: Classification Name
Product Code: Panel: Regulation Number: Device Class:
DD Solid Connect® CAD/CAM AbutmentsAbutment (K19111) Endosseous dental implant abutment Abutment
NHA Dental 21 CFR 872.3630 Class II
5
Device Description
SIMDA Abutment is made of titanium alloy (Ti-6A1-4V ELI. ASTM F136) intended for use as an aid in prosthetic restoration. It consists of Pre-Milled Blank and Ti-Base abutment. It has a premanufactured connection interface that fits directly to an endosseous dental implant.
| Design parameter (Patient-specific abutment) | Subject System
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 | 4.513mm |8mm |
| 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° |
Pre-Milled Blank Design Limitation for Patient-specific abutment:
Ti Base consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM-designed zirconia superstructure (the second part of the two-piece abutment) that composes the final abutment.
Pre-Milled Blank and Ti Base are provided non-sterile therefore must be sterilized after the cementation of the patient-specified superstructure.
Raw material blanks
- InCoris Zi (ZrO2) by Sirona Dental Systems GmbH, L size blanks, cleared under K123664. ●
Cement
- . RelyX Unicem 2Automix by 3M ESPE, cleared under K100756.
6
Design Limitation for Zirconia superstructure:
Image /page/6/Figure/2 description: The image shows a technical drawing of an abutment, along with a table outlining its design parameters and limits. The drawing includes dimensions such as a diameter of 5.0-8.0, a minimum thickness of 0.4, a cuff height of 0.5-5.0, and a post length of 4.0-6.0. The table specifies the minimum and maximum abutment angle as 0-15, the gingival cuff height as 0.5-5.0, the abutment post length as 4.0-6.0, the diameter at the abutment/implant interface as 5.0-8.0, and the minimum wall thickness at the abutment/implant interface as 0.4.
SIMDA Abutment is a device that can only be sold, distributed, or used upon the order of an authorized healthcare provider, generally referred to as prescription (Rx) devices.
7
Image /page/7/Picture/0 description: The image shows the word "SIMDA" in large, bold, blue letters. The letters are sans-serif and appear to be a uniform thickness. The word is presented against a white background, making the blue letters stand out prominently. The overall impression is clean and professional.
Indication for Use
SIMDA Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
| Compatible System | Implant Body
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 |
It is compatible with the following systems:
All digitally designed abutments for use with SIMDA Abutments are intended to be sent to a SMIDA validated milling center for manufacture.
Summary of Technological Characteristics
The subject device and the primary predicate have the same intended use, similar technological characteristics, and are made of the same materials. The subject device and the primary predicate encompass the same range of physical dimensions, are packaged in similar materials, and are to be sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the primary predicate listed above.
8
Non-clinical Testing
MR Environment Condition
Non-clinical worst-case MRI review was performed to evaluate the metallic SIMDA abutment in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalen ce included:
- · Fatigue testing followed ISO 14801 and the FDA special controls guidance document.
- · End User Steam Sterilization Test according to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010.
- · Biocompatibility tests according to ISO 10993-1:2009. ISO 10993-5:2009. and ISO 10993-10:2010.
Non-clinical test data was used to evaluate the proposed device's substantial equivalence compared to the primary predicate. The results of the above tests have demonstrated the substantial equivalence with the primary predicate.
Non-clinical testing was conducted in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments'', and it consisted of testing finished assembled implant/abutment systems of the worstcase scenarios through fatigue testing.
Dimensional analysis and reverse engineering of critical features of critical features and tolerances of the implant-to-abutment connection platform were performed on the OEM implant body, the OEM abutment, and the OEM abutment screw. Cross sectional images wre provided to demonstrate substantially equivalent compatibility. The testing aided implant to abutment compatibility and has established substantial equivalency of the proposed device with the predicate devices.
Clinical testing was not necessary to establish substantial equivalency of the device.
9
Image /page/9/Picture/0 description: The image shows the word "SIMDA" in a bold, sans-serif font. The letters are all capitalized and are a dark blue color. The word is centered and takes up most of the frame.
Primary Predicate / Reference devices:
The subject device is substantially equivalent to the following primary predicate and reference devices:
- Primary Predicate
- TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment (K220562) -
- Reference devices
Comparison between Primary predicates
Pre-Milled Blank
| Feature | Proposed Device | Primary predicate | SE discussion | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SIMDA Abutment | TiGEN Abutment | = | ||||||||||||||||
| Applicant | SIMDA Co., Ltd. | MegaGen Co., Ltd. | = | |||||||||||||||
| Part Name | Pre-Milled Blank | TiGEN Abutment, ZrGEN Abutment | ||||||||||||||||
| and Scan Healing Abutment | = | |||||||||||||||||
| 510(K) No. | K223663 | K220562 | = | |||||||||||||||
| Classification | ||||||||||||||||||
| Name | Endosseous Dental Implant Abutments | |||||||||||||||||
| (872.3630) | Endosseous Dental Implant | |||||||||||||||||
| Abutments (872.3630) | Identical | |||||||||||||||||
| Product Code | NHA | NHA | Identical | |||||||||||||||
| Screw and | ||||||||||||||||||
| Abutment | ||||||||||||||||||
| Material | Ti-6Al-4V ELI | |||||||||||||||||
| (ASTM F136) | Ti-6Al-4V ELI | |||||||||||||||||
| (ASTM F136) | Identical | |||||||||||||||||
| Indications | ||||||||||||||||||
| 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. |
It is compatible with the following
systems:
Compatible System Implant Body
Diameter(mm) Implant
Platform 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® implants
from K140878) 3.3 NC 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. | | | | | | | | | | | | | | | | The TiGEN Abutment, ZrGEN
Abutment and Scan Healing
Abutment are intended for use on
endosseous dental
implants in the edentulous or partially
edentulous maxilla or mandible, as an
aid in prosthetic rehabilitation.
For TiGEN Abutment and ZrGEN
Abutment, all digitally designed
abutments for use with TiGEN
Abutment and
ZrGEN Abutment are intended to be
sent to a MegaGen-validated milling
center for manufacture. | The subject device is
substantially equivalent in
indications and design
principles to the primary
predicate device listed above.
Provided tables are comparing
the Indications for Use
Statements and the
technological characteristics of
the subject device, the primary
predicate device. The
Indications for Use Statement
(IFUS) for the subject device is
substantially equivalent in
intended use to the primary
predicate device. All are
intended for use with
endosseous dental implants in
the maxilla and mandible to
provide functional and esthetic
rehabilitation of the edentulous |
10
SIN く
| Feature | Proposed Device | Primary predicate | SE discussion |
|---|---|---|---|
| SIMDA Abutment | TiGEN Abutment | maxilla and mandible. Slight | |
| differences in the language of | |||
| the subject device and primary | |||
| predicate is Indications for Use | |||
| statements do not affect the | |||
| intended use as an endosseous | |||
| dental implant abutment for | |||
| support of a prosthesis to restore | |||
| chewing function. The minor | |||
| differences between the subject | |||
| device and the primary | |||
| predicate device are related to | |||
| the compatible OEM implant | |||
| lines and the implant platform | |||
| diameter. | |||
| Design Limits | |||
| for patient- | |||
| specific | |||
| abutment | |||
| (Min. ~ Max.) | Maximum Angulation : 0~25° | ||
| Maximum Cuff Height : 0.5~5mm | |||
| Minimum Diameter : Ø 4.0~ Ø 8.0mm | |||
| Minimum Thickness : 0.4mm | |||
| Minimum Post Height : 4~6mm | Standard type | ||
| Minimum wall thickness(mm): 0.47 | |||
| Maximum Angulation : 30° | |||
| Minimum gingival collar height(mm) : | |||
| 2.0 | |||
| Minimum gingival collar height(mm) : | |||
| 5.0 | |||
| Minimum gingival collar(Ø) : 3.5,4.0,4.5 | |||
| Maximum gingival collar(Ø) : 9.5, 11.5 | |||
| Minimum post height : 4.0 | |||
| Maximum post height : 6.0, 6.5 | |||
| Octa level type | |||
| Minimum wall thickness(mm): 0.47 | |||
| Maximum Angulation : 30° | |||
| Minimum gingival collar(Ø) : 4.0 | |||
| Maximum gingival collar(Ø) : 9.5, 11.5 | |||
| Minimum post height : 4.0 | |||
| Maximum post height : 6.0 | The minor difference between | ||
| the two products in the design | |||
| parameters are as follow. | |||
| The minimum diameter of the | |||
| product compatible with the | |||
| subject device is larger than the | |||
| primary predicate device. The | |||
| diameter of the primary | |||
| predicate device is Ø3.5mm~ | |||
| Ø11.5mm, while the subject | |||
| device can be designed from Ø | |||
| 4.0mm up to Ø8.0mm. The | |||
| maximum angle of the product | |||
| compatible with the subject | |||
| device is smaller than the | |||
| primary predicate device. The | |||
| angle of the primary predicate | |||
| device is 30°, while the subject | |||
| device can be designed up to | |||
| 25°. | |||
| The minimum thickness of the | |||
| primary predicate device is | |||
| 0.47, while the subject device | |||
| can be designed up to 0.4. | |||
| The angle of the primary | |||
| predicate device is 30°, while | |||
| the subject device can be | |||
| designed up to 25°. | |||
| The cuff height of the primary | |||
| predicate device is 2.0mm~ | |||
| 5.0mm, while the subject device | |||
| can be designed from 0.5mm up | |||
| to 5.0mm. | |||
| The post height of the primary | |||
| predicate device is 4.0mm~ | |||
| 6.5mm, while the subject device | |||
| can be designed from 4.0mm up | |||
| to 6.0mm | |||
| Feature | Proposed Device | ||
| SIMDA Abutment | Primary predicate | ||
| TiGEN Abutment | SE discussion | ||
| to 6.0mm. Even though there | |||
| are some minor differences in | |||
| dimensions, performance testing | |||
| demonstrated that the subject | |||
| device has substantially | |||
| equivalent fatigue performance. | |||
| Surface | |||
| Treatment | 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.
12
Image /page/12/Picture/0 description: The image shows the word "SIMDA" in a sans-serif font. The letters are a dark blue color. The letters are evenly spaced and the word is centered in the image. The background is white.
Ti Base
| Feature | Proposed Device
SIMDA Abutment | Primary predicate
TiGEN Abutment | Reference Device
DD Prefab | SE discussion |
|------------------------|---------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------|---------------|
| Applicant | SIMDA Co., Ltd. | MegaGen Co., Ltd. | Dental Direkt GmbH | - |
| Part Name | Ti-Base | TiGEN Abutment, ZrGEN Abutment
and Scan Healing Abutment | DD Ti-Base 2CUT | - |
| 510(K) No. | K223663 | K220562 | K191111 | - |
| Classification
Name | Endosseous Dental Implant Abutments
(872.3630) | Endosseous Dental Implant
Abutments (872.3630) | Endosseous Dental Implant
Abutments (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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| Indications
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.
It is compatible with the following
systems:
Compatible System Implant Body
Diameter(mm) Implant
Platform 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® implants
from K140878) 3.3 NC 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. | | | | | | | | | | | | | | | | The TiGEN Abutment, ZrGEN
Abutment and Scan Healing
Abutment are intended for use on
endosseous dental implants in the
edentulous or partially edentulous
maxilla or mandible, as an aid in
prosthetic rehabilitation.
For TiGEN Abutment and ZrGEN
Abutment, all digitally designed
abutments for use with TiGEN
Abutment and
ZrGEN Abutment are intended to be
sent to a MegaGen-validated milling
center for manufacture. | DD Solid Connect® CAD/CAM
Abutments are used to support
prosthetic restorations in
combination with endosseous
dental implants in the upper
and/or lower jaw. DD Prefab
abutments, for the Zimmer
Biomet 3i Certain 3.4mm
implant bodies, and DD Ti-Base
2CUT abutments, for the
Altatech Camlog ScrewLine
3.3mm implant bodies, are
indicated for maxillary lateral
and mandibular central/lateral
incisors only. All digitally
designed custom abutments for
use with DD Solid Connect®
CAD/CAM Abutments are to be
sent to a Dental Direkt validated
milling center for manufacture. | The subject device is
substantially equivalent in
indications and design
principles to the primary
predicate device listed above.
Provided tables are comparing
the Indications for Use
Statements and the
technological characteristics of
the subject device, the primary
predicate device. The
Indications for Use Statement
(IFUS) for the subject device is
substantially equivalent in
intended use to the primary
predicate device. All are
intended for use with
endosseous dental implants in
the maxilla and mandible to
provide functional and esthetic
rehabilitation of the edentulous
maxilla and mandible. Slight
differences in the language of
the subject device and primary
predicate is Indications for Use
statements do not affect the
intended use as an endosseous
dental implant abutment for
support of a prosthesis to restore
chewing function. The minor
differences between the subject
device and the primary
predicate device are related to
the compatible OEM implant
lines and the implant platform
diameter. |
| ------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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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 of | |
| subject devices, 3.8, 4.0, and | |||||
| 4.5, primary predicate devices | |||||
| have various diameters for | |||||
| standard type, C-type, and Octa | |||||
| type. | |||||
| Post height | 3.5, 5.5 | 1.2~8.0 | Not identified | While there are 2 types of | |
| subject devices, 3.5, and 5.5, | |||||
| primary predicate devices have | |||||
| various diameters for standard | |||||
| type, C-type, and Octa type. | |||||
| Thickness | 0.16~0.87 | 0.12~1.35 | Not identified | The thickness of the primary | |
| predicate device is 0.12mm~ | |||||
| 1.35mm, while the subject | |||||
| device can be designed from | |||||
| 0.16mm up to 0.87mm. | |||||
| 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): 5.08.020
-Thickness (mm): 0.4 | Minimum wall thickness (mm) : 0.5
Maximum angulation (°): 0
Minimum gingival collar (Ø) : 8
Maximum gingival collar (Ø): 10
Minimum Gingival collar height
(mm) : 2
Maximum Gingival collar height
(mm) : 5
Minimum post height (mm) : 7
Maximum post height (mm) : 15 | Minimum wall thickness (mm) :
0.5
Maximum angulation (°): 0
Minimum gingival collar (Ø) :
2.7
Maximum gingival collar (Ø) : 7
Minimum Gingival collar height
(mm) : 0.5
Maximum Gingival collar
height (mm) : 6
Minimum post height (mm) : 4
Maximum post height (mm) :
6.5 | | The minor difference between
the two products in the design
parameters are as follow.
The minimum diameter of the
product compatible with the
subject device is larger than the
primary predicate device. The
diameter of the primary
predicate device is Ø8mm~
Ø10mm, while the subject
device can be designed from Ø
5.0mm up to Ø8.0mm.
The angle of the reference
device is 020°, while the
subject device can be designed
up to 15°.
The minimum thickness of the
primary predicate device is 0.5,
while the subject device can be
designed up to 0.4 |
| | | | | The cuff height of the primary
predicate device is 2.0mm
5.0mm, while the subject device
can be designed from 0.5mm up
to 5.0mm.
The post height of the primary
predicate device is 7.0mm~
15mm, while the subject device
can be designed from 4.0mm up
to 6.0mm. | |
| Prothesis
Attachment | Cement-retained, Screw-retained | Cement-retained, Screw-retained | Cement-retained, Screw-
retained | Identical | |
| Surface
Treatment | None | None | None | - | |
| Sterile | steam sterilized before use | steam sterilized before use | steam sterilized before use | Identical | |
15
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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.