(87 days)
No
The summary describes a physical dental abutment made of titanium alloy and focuses on mechanical and biocompatibility testing, with no mention of software, algorithms, or AI/ML terms.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is an abutment for dental implants, which supports prostheses and aids in prosthetic restoration, rather than directly treating a medical condition or disease.
No
This device, SIMDA Abutment, is described as a support for dental prostheses and an aid in prosthetic restoration; it does not perform any diagnostic functions.
No
The device description explicitly states the device is made of titanium alloy and consists of physical components (Pre-Milled Blank and Ti-Base abutment). The performance studies also focus on physical testing (fatigue, sterilization, biocompatibility, dimensional analysis).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for supporting dental prostheses in the maxilla or mandible of a patient. This is a direct clinical application within the body.
- Device Description: The description details a physical component made of titanium alloy used in dental restoration.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) as a structural component for dental prosthetics.
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 |
|---|---|---|
| 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 |
All digitally designed abutments for use with SIMDA Abutments are intended to be sent to a SIMDA validated milling center for manufacture.
Product codes
NHA
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.
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 |Ø8.0 |
| Minimum and Maximum diameter at abutment/implant
interface | Ø4.0
| 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° |
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
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.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K160965, K140091, K102436, K071370, K133731, K013227, K123664, K100756
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Simda Co., Ltd. Cha Young Woo Regulatory Affairs Manager 156-4, Gamjeon-dong Busan, Sasang-gu REPUBLIC OF KOREA
Re: K232271
Trade/Device Name: SIMDA abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: July 28, 2023 Received: July 31, 2023
Dear Cha Young Woo:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232271
Device Name
SIMDA Abutments
Indications for Use (Describe)
SIMDA Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
It is compatible with the following systems:
| Compatible System | Implant Body
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 |
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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4
K 232271 510(k) Summary
Applicant
| Name: | SIMDA Co., Ltd. |
|---|---|
| Address: | 156-4, Gamjeon-dong, Sasang-gu, Busan, South Korea |
| Phone: | +82 70 4256 2855 |
| Contact: | Young Woo, Cha |
| Email: | Email: chassi0406@gmail.com |
| Date Prepared: | 10/25/2023 |
| Subject Device | |
| Trade Name: | SIMDA Abutment |
| Common Name: | Abutment, Implant, Dental, Endosseous |
| Classification Name | Endosseous dental implant abutment |
| Product Code: | NHA |
| Panel: | Dental |
21 CFR 872.3630
Class II
Primary Predicate
Device Class:
Regulation Number:
| Trade Name: |
|---|
| Common Name: |
| Classification Name: |
| Product Code: |
| Panel: |
| Regulation Number: |
| Device Class: |
SIMDA Abutment (K223663) Abutment, Implant, Dental, Endosseous Endosseous dental implant abutment NHA Dental 21 CFR 872.3630 Class II
Reference Device
Trade Name:
Common Name: Classification Name Product Code: Panel: Regulation Number: Device Class:
Dentium Company Limited Implantium (K160965) by Dentium Co., Ltd.
Abutment, Implant, Dental, Endosseous Endosseous dental implant abutment NHA Dental 21 CFR 872.3630 Class II
5
SIMD
| Trade Name: | Xpeed AnyRidge Internal Implant System (K140091) by
MegaGen Implant Co., Ltd. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Abutment, Implant, Dental, Endosseous |
| Classification Name | Endosseous dental implant abutment |
| Product Code: | NHA |
| Panel: | Dental |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | Class II |
| Trade Name: | Nobelactive 3.0 (K102436) By Nobel Biocare
Nobelactive Internal Connection Implant (K071370) By Nobel
Biocare
Nobelactive Wide Platform (Wp) (K133731) By Nobel Biocare |
| Common Name: | Abutment, Implant, Dental, Endosseous |
| Classification Name | Endosseous dental implant abutment |
| Product Code: | NHA |
| Panel: | Dental |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | Class II |
| Trade Name: | Screw Vent® and Tapered Screw Vent® (K013227) by Sulzer
Dental Inc. |
| Common Name: | Abutment, Implant, Dental, Endosseous |
| Classification Name | Endosseous dental implant abutment |
| Product Code: | NHA |
| Panel: | Dental |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | Class II |
| Trade Name: | Nobel Active Wide Platform (K133731) by Sulzer
Dental Inc. |
| Common Name: | Abutment, Implant, Dental, Endosseous |
| Classification Name | Endosseous dental implant abutment |
| Product Code: | NHA |
| Panel: | Dental |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | Class II |
6
Trade Name:
INCORIS ZI (K123664)
Common Name: Classification Name Product Code: Panel: Regulation Number: Device Class:
Powder, porcelain Porcelain powder of clinical use EIH Dental 21 CFR 872.6660 Class II
Trade Name:
Malta, 3M ESPE AG Dental Products (K100756)
Common Name: Classification Name Product Code: Panel: Regulation Number: Device Class:
Self adhesive cement Dental cement other zinc oxide-eugenol EMA Dental 21 CFR 872.3275 Class II
7
Device Description
SIMDA Abutment is made of titanium alloy (Ti-6Al-4V ELI, ASTM F136) intended for use as an aid in prosthetic restoration. It consists of Pre-Milled Blank and Ti-Base abutment. It has a premanufactured connection interface that fits directly to an endosseous dental implant.
| Design parameter (Patient-specific abutment) | Subject System
Design Limit |
|---------------------------------------------------------------------------------------------------|--------------------------------|
| Minimum and Maximum Gingival (Cuff) Height | 0.55mm |Ø8.0 |
| Minimum and Maximum diameter at abutment/implant
interface | Ø4.0
| 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.
8
Image /page/8/Figure/1 description: The image shows a technical drawing of an abutment, including a top-down view and a cross-sectional side view with labeled dimensions. The drawing specifies a diameter of 5.0-8.0, a minimum thickness of 0.4, a cuff height of 0.5-5.0, and a post length of 4.0-6.0. A table below the drawing lists design parameters and their limits, including an abutment angle of 0-15, a gingival cuff height of 0.5-5.0, an abutment post length of 4.0-6.0, a diameter at the abutment/implant interface of 5.0-8.0, and a wall thickness at the abutment/implant interface of 0.4.
Design Limitation for Zirconia superstructure:
SIMDA Abutment is a device that can only be sold, distributed, or used upon the order of an authorized healthcare provider, generally referred to as prescription (Rx) devices.
9
Indication for Use
SIMDA Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
| Compatible System | Implant Body Diameter(mm) | Implant Platform |
|---|---|---|
| Dentium SuperLine | ||
| (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.
10
Non-clinical Testing
MR Environment Condition
Non-clinical worst-case MRI review was performed to evaluate the metallic SIMDA abutment in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalen ce included:
- · Fatigue testing followed ISO 14801 and the FDA special controls guidance document.
- · End User Steam Sterilization Test according to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010.
- · Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
Non-clinical test data was used to evaluate the proposed device's substantial equivalence compared to the primary predicate. The results of the above tests have demonstrated the substantial equivalence with the primary predicate.
Non-clinical testing was conducted in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments", and it consisted of testing finished assembled implant/abutment systems of the worstcase scenarios through fatigue testing.
Dimensional analysis and reverse engineering of critical features of critical features and tolerances of the implant-to-abutment connection platform were performed on the OEM implant body, the OEM abutment, and the OEM abutment screw. Cross sectional images were provided to demonstrate substantially equivalent compatibility. The testing aided implant to abutment compatibility and has established substantial equivalency of the proposed device with the predicate device.
Clinical testing was not necessary to establish substantial equivalency of the device.
11
Primary Predicate / Reference devices:
The subject device is substantially equivalent to the following primary predicate and reference devices:
- Primary Predicate
- SIMDA Abutment (K223663) -
- Reference devices
Comparison between Primary predicates
Pre-Milled Blank
| Feature | Proposed Device
SIMDA Abutment | Primary predicate
SIMDA Abutment | SE discussion | | | | | | | | | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | SIMDA Co., Ltd. | SIMDA Co., Ltd. | = | | | | | | | | | |
| Part Name | Pre-Milled Blank | Pre-Milled Blank | = | | | | | | | | | |
| 510(K) No. | - | K223663 | = | | | | | | | | | |
| 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: | 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: | 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 | | | | | | | | | |
| | | Compatible System Implant Body
Diameter(mm) Implant
Platform Osstem TS (K121995) 3.5, 3.75
3.75, 3.77, 4.2, 4.25, 4.4,
4.6, 4.63, 4.65, 4.9, 5.05,
5.08, 5.1 Mini
Regular Straumann Bone Level
(only the Roxolid® implants
from K140878) 3.3
4.1, 4.8 NC
RC | | | | | | | | | | 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 |
12
SIMI 14
| Feature | Proposed Device
SIMDA Abutment | | | Primary predicate
SIMDA Abutment | SE discussion |
|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Compatible System | Implant Body
Diameter(mm) | Implant
Platform | | |
| | Dentium SuperLine
(K160965) | 3.6, 4.0, 4.5, 5.0, 6.0 | Regular | All digitally designed abutments for
use with SIMDA Abutments are
intended to be sent to a SMIDA
validated milling center for
manufacture. | 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 and the new
compatibilities have been
verified via reverse engineering
and 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 Internal
Connection 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 Tapered
Screw Vent® (K013227) | 4.7 | 4.5 | | |
| | | 6.0 | 5.7 | | |
| | All digitally designed abutments for use
with SIMDA Abutments are intended to
be sent to a SMIDA validated milling
center for manufacture. | | | | |
| Dimension of
Pre-milled
Blank | Total length (mm) : 28.05, 28.25, 28.37, 28.4,
28.45, 28.6, 28.65, 28.9, 28.92
Diameter (mm) : 10, 14 | | | Total length (mm) : 27.88, 28.92, 30.8,
28.9, 28.92
Diameter (mm) : 10, 14 | The minor difference between
the two products in the total
length are as follow.
The total length of predicate
device is 27.88, 28.92, 30.8, 28.9,
28.92, while the subject device is
28.05, 28.25, 28.37, 28.4, 28.45,
28.6, 28.65, 28.9, 28.92 . |
| Design Limits
for patient-
specific
abutment
(Min. ~ Max.) | Maximum Angulation : 025°5mm
Maximum Cuff Height : 0.5
Minimum Diameter : Ø 4.0~ Ø 8.0mm
Minimum Thickness : 0.390.55mm6mm | | | Maximum Angulation : 0
Minimum Post Height : 425°5mm
Maximum Cuff Height : 0.5
Minimum Diameter : Ø 4.0~ Ø 8.0mm
Minimum Thickness : 0.4mm
Minimum Post Height : 46mm | The minor difference between0.55. This
the two products in the design
parameters are as follow.
The minimum thickness of the
primary predicate device is 0.4,
while the subject device can be
designed up to 0.39
change in technological
characteristics was evaluated as
part of the performance testing
and was determined to not
impact the performance of the
device." |
| Surface
Treatment | None | | | None | - |
| Sterile | Non-sterile | | | Non-sterile | - |
13
SIM く
Ti Base
| Feature | Proposed Device
SIMDA Abutment | Primary predicate
SIMDA Abutment | SE discussion | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|---------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | SIMDA Co., Ltd. | SIMDA Co., Ltd. | - | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Part Name | Ti-Base | Ti-Base | - | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510(K) No. | - | K223663 | - | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Classification
Name | Endosseous Dental Implant Abutments
(872.3630) | Endosseous Dental Implant
Abutments (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 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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 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) 4.3, 5.0 RP 5.5 WP Screw Vent® and Tapered
Screw Vent® (K013227) 3.7, 4.1 3.5 4.7 4.5 6.0 5.7 All digitally designed abutments for use
with SIMDA Abutments are intended to
be sent to a SIMDA validated milling
center for manufacture. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 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 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 |
14
| Feature | Proposed Device
SIMDA Abutment | Primary predicate
SIMDA 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 between
the two products in the gingival
collar are as follow.
The gingival collar of predicate
device is 3.8, 4.0, 4.5, while the
subject 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 | 0.160.87 | 0.160.87 | Idential |
| 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): 5.08.015
-Thickness (mm): 0.4 | | - Post Angle (°): 0 - Cuff Height (mm): 0.5
5.06.0
-Post Length (mm): 4.0
-Diameter (Ø, mm): 5.0~8.0
-Thickness (mm): 0.4 | Idential |
| Prothesis
Attachment | Cement-retained, Screw-retained | | Cement-retained, Screw-retained | Identical |
| Surface
Treatment | 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.
15
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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.