(417 days)
Not Found
No
The provided text describes a dental implant system made of specific materials and intended for prosthetic rehabilitation. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities that would suggest the use of AI/ML. The performance studies focus on material properties, sterilization, and compatibility, not algorithmic performance.
No.
The device is described as prefabricated prosthetic components for direct connection to dental implants, intended to aid in prosthetic rehabilitation by supporting single-unit prosthetic restorations. Its purpose is structural support, not direct treatment of a disease or condition.
No
This device is described as prefabricated prosthetic components (abutments) for dental implants, used in prosthetic rehabilitation to support single unit prosthetic restorations. It is not intended for the purpose of diagnosis.
No
The device description explicitly states it is made of Ti-6A1-4V ELI alloy and consists of physical components (Dual Abutment and Healing Abutment). This indicates a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the TDS are "prefabricated prosthetic components for direct connection to endosseous dental implants and are intended to be used as an aid in prosthetic rehabilitation." This describes a device used in vivo (within the body) for structural support and restoration, not a device used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the physical components (abutments), material (Ti-6A1-4V ELI alloy), and surface treatments. This aligns with a medical device intended for implantation or connection to an implant, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility, surface characteristics, sterilization, MRI compatibility, and compatibility with implants – all relevant to an implantable or connected medical device, not an IVD.
In summary, the TDS is a dental prosthetic component, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TDS (TECHWIN DENTAL SYSTEM) are prefabricated prosthetic components for direct connection to endosseous dental implants and are intended to be used as an aid in prosthetic rehabilitation. It is intended for use in edentulous and partially edentulous patients with established bone and completed growth period to support single unit prosthetic restorations in the mandible or maxilla. It is intended for one-stage surgical procedures. This system is intended for delayed loading.
The TDS (TECHWIN DENTAL SYSTEM) is compatible with the following devices:
| No. | Subject
Device | Implantable
Diameters (mm) | Compatible
Implants (510k
No.)/Manufacture | Type of Implant
Abutment
Connection/ | Implant
Platform
Type | Implant Platform
Platform
Diameters(mm) | Implant Body
Diameter
(mm) |
|---|---|---|---|---|---|---|---|
| 1. | Dual
Abutment | Ø4.0, 4.6 | Chaorum
Implant System
(K160536)/
MEDIMECCA
CO., LTD. | Hex or non-hex/
2.1 Hex | Narrow
(mini) | Ø3.25, 3.89 | Ø3.0, 3.5 |
| | | Ø4.5, 4.6, 5.0, 5.5,
6.0, 6.5, 7.0 | | Hex or non-hex/
2.5 Hex | Wide
(Regular) | Ø3.89, 4.28,
4.78, 5.28, 6.28 | Ø3.9, 4.0, 4.4,
4.5, 4.9, 5.5, 5. |
| 2. | Healing
Abutment | Ø4.3, 4.8 | | Hex or non-hex/
2.1 Hex | Narrow
(mini) | Ø3.25, 3.89 | Ø3.0, 3.5 |
| | | Ø4.0, 4.3, 4.5, 4.6,
4.8, 5.3, 5.5, 5.6, 6.3.
6.5, 7.3, 7.5, 8.3, 8.5 | | Hex or non-hex/
2.5 Hex | Wide
(Regular) | Ø3.89, 4.28,
4.78, 5.28, 6.28 | Ø3.9, 4.0, 4.4,
4.5, 4.9, 5.5, 5. |
| 3. | Abutment
Screw | Ø2.22 | | - | Narrow
(mini) | - | - |
| | | Ø2.1, 2.3, 2.32, 2.5 | | | Wide
(Regular) | - | - |
Product codes
NHA
Device Description
The TDS (TECHWIN DENTAL SYSTEM), made of Ti-6A1-4V ELI alloy (ASTM F136), is intended for use in conjunction with the appliance in partially or fully edentulous mandibles and maxillae to support single-unit loading (i.e., crown). It consists of the Dual Abutment and Healing Abutment. The surface of the abutments is uncoated or partially or half coated with TiN using AIP (Arc Ion Plating). The implant-to-abutment interface remains uncoated. All abutments are supplied non-sterile and must be autoclaved by the end-user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla
Indicated Patient Age Range
patients with established bone and completed growth period
Intended User / Care Setting
Not Found
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)
Nonclinical tests were performed.
Biocompatibility testing: Cytotoxicity testing according to ISO 10993-5:2009, irritation testing according to ISO 10993-10:2010 and ISO 10993-23:2021, and implantation testing according to ISO 10993-6:2016 was performed to demonstrate the subject device is substantially equivalent to the predicate device (K160536).
Surface treatment analysis: Included chemical composition analysis, scanning electron microscopy analysis, surface roughness measurements, coating thickness and porosity evaluation, mean volume percent of voids calculation, and abrasion characteristics assessment.
Sterilization validation: User moist heat sterilization validation was conducted according to ISO 17665-1:2006 and ISO/TS 17665-2:2009 and demonstrated a SAL of 10-6.
MRI review: A non-clinical worst-case MRI review was performed to evaluate the subject device components in the MRI environment using scientific rationale and published literature, addressing magnetically induced displacement force and torque.
Reverse engineering analysis: Performed to ensure compatibility with third-party implants, involving precise measurements of implant-abutment interfaces, tolerances, and connection geometries of OEM implant bodies, OEM abutments, and OEM abutment screws.
No clinical tests were included.
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.
Not Found
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.
TECHWIN Co., Ltd. % Kyung-Hwan Kim Representative Consultant SMB Korea #606, #607, 7, Boramae-ro 5ga-gil, Donjak-gu Seoul, 07071 REPUBLIC OF KOREA
August 20, 2024
Re: K231932
Trade/Device Name: TDS (TECHWIN DENTAL SYSTEM) Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: July 16, 2024 Received: July 23, 2024
Dear Kyung-Hwan Kim:
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) K231932
Device Name
TDS (TECHWIN DENTAL SYSTEM)
Indications for Use (Describe)
The TDS (TECHWIN DENTAL SYSTEM) are prefabricated prosthetic components for direct connection to endosseous dental implants and are intended to be used as an aid in prosthetic rehabilitation. It is intended for use in edentulous and partially edentulous patients with established bone and completed to support single unit prosthetic restorations in the mandible or maxilla. It is intended for one-stage surgical procedures. This system is intended for delayed loading.
The TDS (TECHWIN DENTAL SYSTEM) is compatible with the following devices:
| No. | Subject
Device | Implantable
Diameters (mm) | Compatible
Implants (510k
No.)/Manufacture | Type of Implant
Abutment
Connection/ | Implant
Platform
Type | Implant Platform
Platform
Diameters(mm) | Implant Body
Diameter
(mm) |
|-----|---------------------|-----------------------------------------------------------------------------|-------------------------------------------------------------------|--------------------------------------------|-----------------------------|-----------------------------------------------|--------------------------------------|
| 1. | Dual
Abutment | Ø4.0, 4.6 | Chaorum
Implant System
(K160536)/
MEDIMECCA
CO., LTD. | Hex or non-hex/
2.1 Hex | Narrow
(mini) | Ø3.25, 3.89 | Ø3.0, 3.5 |
| | | Ø4.5, 4.6, 5.0, 5.5,
6.0, 6.5, 7.0 | | Hex or non-hex/
2.5 Hex | Wide
(Regular) | Ø3.89, 4.28,
4.78, 5.28, 6.28 | Ø3.9, 4.0, 4.4,
4.5, 4.9, 5.5, 5. |
| 2. | Healing
Abutment | Ø4.3, 4.8 | | Hex or non-hex/
2.1 Hex | Narrow
(mini) | Ø3.25, 3.89 | Ø3.0, 3.5 |
| | | Ø4.0, 4.3, 4.5, 4.6,
4.8, 5.3, 5.5, 5.6, 6.3.
6.5, 7.3, 7.5, 8.3, 8.5 | | Hex or non-hex/
2.5 Hex | Wide
(Regular) | Ø3.89, 4.28,
4.78, 5.28, 6.28 | Ø3.9, 4.0, 4.4,
4.5, 4.9, 5.5, 5. |
| 3. | Abutment
Screw | Ø2.22 | | - | Narrow
(mini) | - | - |
| | | Ø2.1, 2.3, 2.32, 2.5 | | | Wide
(Regular) | - | - |
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
TECHWIN Co., Ltd Traditional 510(k) Premarket Submission TDS (TECHWIN DENTAL SYSTEM) K231932
Image /page/5/Picture/1 description: The image shows the logo for SMB Korea, a consulting expert group. The logo features the text "SMB Korea" in a gray, sans-serif font. Below the text is the tagline "A Member of the Consulting Expert Group" in a smaller, lighter gray font. A curved line underlines the "SMB" portion of the logo, adding a visual element to the design.
510(k) Summary
For
TDS (TECHWIN DENTAL SYSTEM)
[Complying with 21 CFR 807.92]
SUBMISSION SPONSOR l.
TECHWIN Co., Ltd. #401, Eungyenam-gil 40, Siheung-si, Gyeonggi-do, Republic of Korea Office Phone: +82-31-365-5601 Email: tw rnd@techwinkorea.com Contact Person: Mr. Min-jae Jo, QMR
II. SUBMISSION CORRESPONDENT
SMB Korea #606, #607, 7, Boramae-ro 5ga-gil, Donjak-gu, Seoul, 07071, Republic of Korea Cell Phone: +82-10-2247-5579 Office Phone: +82-2-6241-9001 Kyung-hwan Kim, Representative Consultant RA/QA Contact: Email: info@smbkorea.com
III. DATE PREPARED
August 19, 2024
IV. DEVICE
| Trade or Proprietary Name: | TDS (TECHWIN DENTAL SYSTEM) |
|---|---|
| Common or Usual Name: | Endosseous Dental Implant Abutment |
| Classification Name: | Abutment, Implant, Dental, Endosseous (872.3630) |
| Regulatory Class: | II |
| Product Code: | NHA |
| Classification Panel: | Dental |
V. PREDICATE DEVICE
Primary Predicate Device: K160536, Chaorum Implant System / Medimecca Co., Ltd.
6
Image /page/6/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and consists of the text "SMB Korea" with a curved line underneath. Below the line, it says "A Member of the Consulting Expert Group" in a smaller font. The logo is simple and professional.
VI. DEVICE DESCRIPTION
The TDS (TECHWIN DENTAL SYSTEM), made of Ti-6A1-4V ELI alloy (ASTM F136), is intended for use in conjunction with the appliance in partially or fully edentulous mandibles and maxillae to support single-unit loading (i.e., crown). It consists of the Dual Abutment and Healing Abutment. The surface of the abutments is uncoated or partially or half coated with TiN using AIP (Arc Ion Plating). The implant-to-abutment interface remains uncoated. All abutments are supplied non-sterile and must be autoclaved by the end-user.
The TDS (TECHWIN DENTAL SYSTEM) is compatible with the following devices:
| No. | 510k No. | Trade Name | | Platform Type | Platform Diameters
(mm) | Manufacture |
|-----|----------|------------|---------|---------------|----------------------------|---------------------|
| | K160536 | Chaorum | Implant | Narrow | Ø3.253.89 | MEDIMECCA CO., LTD. |6.28 | |
| | | System | | Regular | Ø3.89
| Abutment | Diameter (ø) | Post
Height
(mm) | Total Length (mm) | Cuff Height
(mm) | Angulation
(°) | Surface |
|---------------------|-------------------------------------------------------------------------------|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|-------------------|--------------------|
| Dual
Abutment | 4.0, 4.5, 4.6, 5.0,
5.5, 6.0, 6.5, 7.0 | 4.0, 5.5,
7.0 | 7.5, 8.5, 9.0, 9.1, 9.2, 9.5, 9.7, 10.0, 10.1,
10.5, 10.6, 10.7, 10.85, 11.0, 11.1, 11.2,
11.5, 11.6, 11.7, 11.85, 12.0, 12.1, 12.2,
12.5, 12.6, 12.7, 12.85, 13.0, 13.1, 13.2,
13.5, 13.6, 13.7, 13.85, 14.0, 14.2, 14.5,
14.6, 14.85, 15.2 | 1.0, 1.3, 1.8,
2.3, 2.8, 3.3,
3.8, 4.3, 4.8,
5.3 | - | TiN
coating |
| Healing
Abutment | 4.0, 4.3, 4.5, 4.6,
4.8, 5.3, 5.5, 5.6,
6.3, 6.5, 7.3, 7.5,
8.3, 8.5 | 2.0, 3.0,
3.5, 4.0,
5.0, 5.5,
7.0 | 7.5, 8.5, 8.7, 9.5, 10.5, 11.0, 11.5, 12.0,
12.5, 14.0, 14.5 | 1.0, 2.0, 3.0,
4.0, 5.0 | - | Non/TiN
coating |
| Abutment
Screw | 2.1, 2.22, 2.3,
2.32, 2.5 | - | 8, 8.35, 8.5, 8.8, 9.8, 10.1, 10.2 | - | - | Machined |
The abutment's dimension range is as follows:
7
Image /page/7/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and features the text "SMB Korea" in a sans-serif font. A curved line extends from under the "S" in SMB to under the "K" in Korea. Below the text is the phrase "A Member of the Consulting Expert Group" in a smaller font.
VII. INDICATION FOR USE
The TDS (TECHWIN DENTAL SYSTEM) are prefabricated prosthetic components for direct connection to endosseous dental implants and are intended to be used as an aid in prosthetic rehabilitation. It is intended for use in edentulous and partially edentulous patients with established bone and completed growth period to support single unit prosthetic restorations in the mandible or maxilla. It is intended for one-stage and twostage surgical procedures. This system is intended for delayed loading.
| No. | Subject
Device | Implantable
Diameters (mm) | Compatible
Implants (510k
No.)/
Manufacture | Type of Implant -
Abutment
Connection/
Diameter (mm) | Implant
Platform
Type | Implant
Platform
Diameters
(mm) | Implant Body
Diameters
(mm) |
|-----|---------------------|-----------------------------------------------------------------------------|------------------------------------------------------|---------------------------------------------------------------|-----------------------------|------------------------------------------|------------------------------------------|
| 1. | Dual
Abutment | Ø4.0, 4.6 | Chaorum
Implant System
(K160536)/ | Hex or non-hex/
2.1 Hex | Narrow
(mini) | Ø3.25, 3.89 | Ø3.0, 3.5 |
| | | Ø4.5, 4.6, 5.0, 5.5,
6.0, 6.5, 7.0 | MEDIMECCA
CO., LTD. | Hex or non-hex/
2.5 Hex | Wide
(Regular) | Ø3.89, 4.28,
4.78, 5.28,
6.28 | Ø3.9, 4.0, 4.4,
4.5, 4.9, 5.5,
5.9 |
| 2. | Healing
Abutment | Ø4.3, 4.8 | | Hex or non-hex/
2.1 Hex | Narrow
(mini) | Ø3.25, 3.89 | Ø3.0, 3.5 |
| | | Ø4.0, 4.3, 4.5, 4.6,
4.8, 5.3, 5.5, 5.6, 6.3,
6.5, 7.3, 7.5, 8.3, 8.5 | | Hex or non-hex/
2.5 Hex | Wide
(Regular) | Ø3.89, 4.28,
4.78, 5.28,
6.28 | Ø3.9, 4.0, 4.4,
4.5, 4.9, 5.5,
5.9 |
| 3. | Abutment
Screw | Ø2.22 | | | Narrow
(mini) | - | - |
| | | Ø2.1, 2.3, 2.32, 2.5 | | | Wide
(Regular) | - | - |
The TDS (TECHWIN DENTAL SYSTEM) is compatible with the following devices:
VIII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| | SUBJECT Device | Primary PREDICATE Device
(K160536) | Significant
Difference |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Manufacturer | TECHWIN Co., Ltd. | Medimecca Co., Ltd. | - |
| Trade Name | TDS (TECHWIN DENTAL SYSTEM) | Chaorum Implant System | - |
| Regulation
Description | Endosseous Dental Implant System | Endosseous Dental Implant System | - |
| Regulation
Number | 21 CFR 872.3630 | 21 CFR 872.3630 | No difference. |
| Product Code | NHA | NHA | No difference. |
| Class | II | II | No difference. |
| Indications | The TDS (TECHWIN DENTAL
SYSTEM) are prefabricated
prosthetic components for direct
connection to endosseous dental
implants and are intended to be
used as an aid in prosthetic
rehabilitation. It is intended for use
in edentulous and partially
edentulous patients with | Chaorum Implant System is
intended for use in partially or fully
edentulous mandibles and maxilla,
in support of single of multiple-unit
restorations including; cemented
retained, screw retained, or
overdenture restorations, and
terminal or intermediate abutment
support for fixed bridgework. | Similarities |
8
Image /page/8/Picture/1 description: The image contains the logo for SMB Korea, a consulting expert group. The logo features the text "SMB Korea" in a stylized font, with a curved line extending from the bottom of the "B" in SMB. Below the main text, in a smaller font, is the phrase "A Member of the Consulting Expert Group."
| A Member of the Consulting Expert Group | |||||
|---|---|---|---|---|---|
| ----------------------------------------- | -- | -- | -- | -- | -- |
| | SUBJECT Device | Primary PREDICATE Device
(K160536) | Significant
Difference |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| | established bone and completed
growth period to support single
unit prosthetic restorations in the
mandible or maxilla. It is intended
for one-stage and two-stage
surgical procedures. This system is
intended for delayed loading. | Chaorum Implant System is for
single stage and two stage surgical
procedures. This system is
intended for delayed loading. | |
| | Dual Abutment | | |
| Design | | | Similarities |
| | Image: [Hex/Non-hex O-type] | Image: [Hex/Non-hex] | |
| | Image: [Hex/Non-hex D-type] | | |
| | Image: [Hex I-type] | | |
| Diameter (ø) | [Hex/Non-hex O-type]
: 4.0, 4.6, 5.0, 6.0, 7.0 mm
[Hex/Non-hex D-type]
: 4.5, 5.5, 6.5 mm
[Hex I-type]
: 4.5, 5.5 mm | 3.5, 4.0, 4.5, 5.5, 5.5, 6.0, 6.5 mm | Similarities |
| Post Height | 4.0, 5.5, 7.0 mm | 4.5, 5.5, 7.0 mm | Similarities |
| Gingival Height | [Hex/Non-hex O-type]
: 1.0, 1.8, 2.8, 3.8, 4.8 mm
[Hex/Non-hex D-type]
: 1.0, 1.3, 2.3, 3.3, 4.3, 5.3 mm
[Hex I-type]
: 1.0, 1.8, 2.8, 3.8, 4.8 mm | 0.85, 1.35, 2.35, 3.35, 4.35, 5.35 mm | Similarities |
| Raw material | Ti-6Al-4V ELI Titanium Alloy | Titanium Grade 4 | Similarities |
| Connection
Interface | Hex, Non-hex | Hex, Non-hex | No difference |
| Surface
Treatment | TiN Coating | TiN Coating | No difference. |
| Sterilization | Non-sterile; Steam sterilization
prior to use | Non-sterile; Steam sterilization
prior to use | No difference. |
| Single
Use Only | Single use Only | Single use Only | No difference. |
| | SUBJECT Device | Primary PREDICATE Device
(K160536) | Significant
Difference |
| Biocompatibility | Biocompatible according to ISO
10993-1 | Biocompatible according to ISO
10993-1 | No difference. |
| SE | The subject device has a similar intended use, material, and design as the predicate device,
with only minor differences in dimensions. While the subject device is indicated for single-
unit loading only, as opposed to single and multiple-unit loading for the predicate device,
this represents a more conservative approach that doesn't introduce additional risks. The
abutment gingival height range of the subject device falls within the range of the predicate
device, and the minor differences in diameter and post height are intended to meet
individual patient needs without compromising performance or safety. The 4.0 mm
minimum abutment post height of the subject device, compared to the 4.5 mm of the
predicate device, allows for greater flexibility to accommodate patient-specific anatomical
variations without affecting safety or effectiveness. Although the subject device uses Ti-6Al-
4V ELI titanium alloy instead of titanium grade 4 used in the predicate, both materials are
well-established in dental implant applications, with Ti-6AI-4V ELI offering improved
mechanical properties and biocompatibility. The connection interface remains the same
between the devices. These differences do not raise any new safety or effectiveness issues,
maintaining substantial equivalence between the subject and predicate devices. | | |
| | | | |
| Design | Image: [O-type]
Image: [D-type]
Image: [I-type] | Image: [O-type] | Similarities |
| Diameter (ø) | [O-type]
: 4.3, 4.8, 5.3, 6.3, 7.3, 8.3 mm
[D-type]
: 4.0, 4.5, 5.5, 6.5, 7.5, 8.5 mm
[I-type]
: 4.6, 5.6 mm | 3.5 ~ 8.5 mm | Similarities |
| Post Height | [O-type]
: 3.0, 4.0, 5.0, 7.0 mm
[D-type]
: 2.0, 3.5, 5.0, 7.0 mm
[I-type] | 2.0 ~ 7.0 mm | Similarities |
| | SUBJECT Device | Primary PREDICATE Device
(K160536) | Significant
Difference |
| | : 4.0, 5.5, 7.0 mm | | |
| Gingival Height | [O-type]
: 1.0, 2.0, 3.0, 5.0 mm
[D, I-type]
: 2.0, 3.0, 4.0 mm | 0.0 ~ 5.5 mm | Similarities |
| Raw material | Ti-6Al-4V ELI Titanium Alloy | Titanium Grade 4 | Similarities |
| Surface
Treatment | Non/TiN Coating | TiN Coating | Similarities |
| Sterilization | Non-sterile; Steam sterilization
prior to use | Non-sterile; Steam sterilization
prior to use | No difference. |
| Single
Use/Reuse | Single use Only | Single use Only | No difference. |
| Biocompatibility | Biocompatible according to ISO
10993-1 | Biocompatible according to ISO
10993-1 | No difference. |
| SE | The subject device has a similar intended use, material, and design as the predicate device, with only minor differences in dimensions. The abutment post height and gingival height range of the subject device fall within the range of the predicate device. While there are minor differences in diameter, these variations are intended to meet individual patient needs and do not compromise performance or safety due to their minimal nature. The subject device uses Ti-6Al-4V ELI titanium alloy, whereas the predicate uses titanium grade 4. Both materials are well-established in dental implant applications, with Ti-6Al-4V ELI offering improved mechanical properties and biocompatibility. This material difference maintains substantial equivalence without raising new safety or efficacy concerns. Additionally, the subject device offers both non-coated and TiN-coated options for the Healing Abutment, while the predicate device uses only TiN coating. This flexibility in surface treatment allows for customization based on specific clinical needs without compromising the device's overall performance or biocompatibility. Furthermore, the connection interface remains the same between the devices. These minor variations do not introduce any new issues in performance or safety, thus maintaining substantial equivalence between the subject and predicate devices. | | |
| | Abutment Screw | | |
| Design |
Image: [Abutment Screw O-type] |
Image: [Abutment Screw] | Similarities |
| | [O-type] | | |
| | Image: [Abutment Screw D-type] | | |
| | [D-type] | | |
| | Image: [Abutment Screw N-type] | | |
| | [N-type] | | |
| | SUBJECT Device | Primary PREDICATE Device
(K160536) | Significant
Difference |
| | Image: [LA-type]
Image: [TA-type]
Image: [MR-type]
Image: [MO-type] | | |
| Diameter (ø) |
[O-type]: 2.22, 2.32 mm
[D, N, TA, MO-type]: 2.3 mm
[LA-type]: 2.5 mm
[MR-type]: 2.1 mm | 2.3 mm | Similarities |
| Total Length |
[O-type]: 8.35, 10.2 mm
[D -type]: 10.2 mm
[N-type]: 8.8 mm
[LA-type]: 8.5 mm
[TA-type]: 9.8 mm
[MR-type]: 8.0 mm
[MO-type]: 10.1 mm | 9.7 ~ 11.3 mm | Similarities |
| Raw material | Ti-6Al-4V ELI Titanium Alloy | Titanium Grade 4 | Similarities |
| Connection | Internal Conical Connection | Internal Conical Connection | No difference. |
| Interface
Surface | Machined | Machined | No difference. |
| Treatment
Sterilization | Non-sterile; Steam sterilization
prior to use | Non-sterile; Steam sterilization
prior to use | No difference. |
| Single
Use/Reuse | Single use Only | Single use Only | No difference. |
| Biocompatibility | Biocompatible according to ISO
10993-1 | Biocompatible according to ISO
10993-1 | No difference. |
| | SUBJECT Device | Primary PREDICATE Device (K160536) | Significant
Difference |
| SE | The subject device has a similar intended use, material, and design as the predicate device, with only minor differences in dimensions. The range of diameter and total length of the subject device are designed to meet individual patient needs and do not raise any performance or safety issues due to the minimal nature of these size differences. While the subject device uses Ti-6Al-4V ELI titanium alloy and the predicate uses titanium grade 4, both materials are well-established in dental implant applications. Ti-6Al-4V ELI offers improved mechanical properties and biocompatibility, maintaining substantial equivalence without introducing new safety or efficacy concerns. Furthermore, the connection interface remains the same between the devices. These minor variations in dimensions and material do not compromise the device's performance or safety, thus maintaining substantial equivalence between the subject and predicate devices. | | |
9
Image /page/9/Picture/1 description: The image shows the logo for SMB Korea, a consulting expert group. The logo is in gray and features the text "SMBKorea" in a stylized font. Below the text is the tagline "A Member of the Consulting Expert Group" in a smaller font. The logo is simple and professional, conveying a sense of expertise and reliability.
ng Expert Group
10
Image /page/10/Picture/1 description: The image shows the logo for SMB Korea, a member of the Consulting Expert Group. The logo is in gray and features the letters "SMB" in a bold, sans-serif font, followed by "Korea" in a similar font. Below the main text, in a smaller font, is the phrase "A Member of the Consulting Expert Group."
11
TECHWIN Co., Ltd Traditional 510(k) Premarket Submission
TDS (TECHWIN DENTAL SYSTEM) K231932
Image /page/11/Picture/1 description: The image shows the logo for SMB Korea, which is part of the Consulting Expert Group. The logo features the letters "SMB" in a bold, sans-serif font, with a stylized swoosh underneath. The word "Korea" is placed to the right of "SMB", and the tagline "A Member of the Consulting Expert Group" is located below the main logo.
12
Image /page/12/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and consists of the letters "SMB" followed by the word "Korea". Underneath the logo is the text "A Member of the Consulting Expert Group" in a smaller font size. There is a curved line that starts under the "S" and extends to the "B".
A Member of the Consulting Expert Group
IX. NONCLINICAL TEST
The following performance data was provided in support of the substantial equivalence determination.
Biocompatibility
Biocompatibility classification is based on the FDA Guidance Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process."
The subject devices are classified as an implant medical device, tissue/bone, long-term exposure (>30 days).
The subject devices have fulfilled all testing required by ISO 7405:2018, "Dentistry -Evaluation of biocompatibility of medical devices used in dentistry", ISO 10993-1:2018, "Biological evaluation of medical devices – Part 1: Evaluation and testing" and the FDA guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Cytotoxicity testing according to ISO 10993-5:2009 "Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity", irritation testing according to ISO 10993-10:2010 and ISO 10993-23:2021, and implantation testing according to ISO 10993-6:2016 was performed to demonstrate the subject device is substantially equivalent to the predicate device (K160536).
Surface treatment
Surface treatment analysis was conducted in-house for the TDS (TECHWIN DENTAL SYSTEM). This included chemical composition analysis, scanning electron microscopy analysis, surface roughness measurements, coating thickness and porosity evaluation, mean volume percent of voids calculation, and abrasion characteristics assessment.
13
Image /page/13/Picture/1 description: The image shows the logo for SMB Korea, which is part of the Consulting Expert Group. The logo features the text "SMB Korea" in a sans-serif font, with a stylized swoosh graphic element underneath the letters "SMB". Below the main text, in a smaller font size, is the tagline "A Member of the Consulting Expert Group."
Sterilization
The non-sterile abutments used in the surgery must be sterilized by the end user, prior to use, as specified in the IFU. User moist heat sterilization validation for the subject non-sterile devices was conducted according to, ISO 17665-1:2006, "Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices", and ISO/TS 17665-2:2009, "Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ISO 17665-1" and demonstrated a SAL of 10-6.
A non-clinical worst-case MRI review was performed to evaluate the subject device components 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, abutments) and material composition. The rationale addressed parameters according to the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque.
Reverse engineering analysis
Reverse engineering was performed to ensure compatibility with third-party implants. This process involved precise measurements of implant-abutment interfaces, tolerances, and connection geometries. Reverse engineering of OEM implant bodies, OEM abutments, and OEM abutment screws was performed to ensure compatibility with third-party implants.
X. CLINICAL TESTS
This 510(k) does not include data from clinical tests.
XI. CONCLUSIONS
The above information supports that the TDS (TECHWIN DENTAL SYSTEM) is as safe and effective as the predicate device. Although there are minor design differences between the device under subject device and the predicate device, the review supports that these differences do not raise new questions of safety and effectiveness. Therefore, it is concluded that the TDS (TECHWIN DENTAL SYSTEM) is substantially equivalent to the predicate device.