(417 days)
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 two-stage surgical procedures. This system is intended for delayed loading.
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.
This looks like a 510(k) premarket notification for a dental implant abutment system, not a software or AI-enabled device. Therefore, the detailed information about acceptance criteria, study design, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI/software device wouldn't be present in this document.
The document describes the acceptance criteria for the TDS (TECHWIN DENTAL SYSTEM) primarily through demonstrating substantial equivalence to an existing predicate device (K160536, Chaorum Implant System / Medimecca Co., Ltd.) through non-clinical testing.
Here's a breakdown of the information that can be extracted relevant to acceptance criteria and the studies performed, while noting the absence of AI/software-specific details:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of performance metrics like sensitivity, specificity, or AUC for an AI device, the "acceptance criteria" for this physical device are met by demonstrating comparable properties and performance to the predicate device through various non-clinical tests.
| Acceptance Criteria Category | Specific Criteria / Test Type | Reported Device Performance (TDS - TECHWIN DENTAL SYSTEM) |
|---|---|---|
| Biocompatibility | Adherence to ISO 10993-1, ISO 7405, ISO 10993-5, ISO 10993-10, ISO 10993-23, ISO 10993-6 requirements. | Fulfilled all required testing; demonstrated to be substantially equivalent to predicate device. |
| Surface Treatment | Chemical composition analysis, SEM, surface roughness, coating thickness/porosity, mean volume percent of voids, abrasion characteristics. | Conducted in-house analysis for these parameters. |
| Sterilization | Validation of moist heat sterilization according to ISO 17665-1 and ISO/TS 17665-2. | Demonstrated a Sterility Assurance Level (SAL) of 10^-6. |
| MRI Safety | Assessment of magnetically induced displacement force and torque based on FDA guidance and scientific rationale. | Non-clinical worst-case MRI review performed using scientific rationale and published literature. |
| Compatibility (Reverse Engineering) | Precise measurements of implant-abutment interfaces, tolerances, and connection geometries. | Performed to ensure compatibility with third-party implants (OEM implant bodies, OEM abutments, and OEM abutment screws). |
| Material | Ti-6Al-4V ELI Titanium Alloy (for mechanical properties and biocompatibility). | Ti-6Al-4V ELI offers improved mechanical properties and biocompatibility compared to predicate's Titanium Grade 4. |
| Intended Use | Aid in prosthetic rehabilitation for single-unit restorations in edentulous and partially edentulous patients with established bone and completed growth. Intended for one-stage surgical procedures and delayed loading. | Similar intended use to predicate, with a more conservative approach (single-unit loading only) which doesn't introduce additional risks. |
| Form/Fit/Function (Dimensions) | Comparison of various dimensions (diameter, post height, gingival height, total length) with predicate device. | Minor differences in dimensions (diameter, post height, gingival height, length) noted but deemed to meet individual patient needs without compromising performance or safety. These differences do not raise new safety or effectiveness issues. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable in the context of an AI/software test set. For the non-clinical tests, specific sample sizes for material tests or sterilization validation are not detailed in this summary but would be part of the full submission.
- Data Provenance: The tests are non-clinical, primarily laboratory-based, and compare the subject device's properties against established international standards and the predicate device's characteristics. The company is based in the Republic of Korea.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as there is no "ground truth" to be established by experts in the context of an AI/software's diagnostic performance. The evaluations are based on engineering and material science standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as this is not an AI/software diagnostic performance study requiring expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a physical medical device (dental implant abutment system), not an AI-enabled device. Therefore, no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable to this type of device submission. The "truth" is based on the adherence of the device's physical, chemical, and biological properties to established international standards and the characteristics of the legally marketed predicate device.
8. The sample size for the training set
- Not applicable. This is not an AI/software device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/software device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) 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. | SubjectDevice | ImplantableDiameters (mm) | CompatibleImplants (510kNo.)/Manufacture | Type of ImplantAbutmentConnection/ | ImplantPlatformType | Implant PlatformPlatformDiameters(mm) | Implant BodyDiameter(mm) |
|---|---|---|---|---|---|---|---|
| 1. | DualAbutment | Ø4.0, 4.6 | ChaorumImplant System(K160536)/MEDIMECCACO., 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. | HealingAbutment | 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. | AbutmentScrew | 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.
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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.
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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 | Ø3.25~3.89 | MEDIMECCA CO., LTD. | |
| System | Regular | Ø3.89~6.28 |
| Abutment | Diameter (ø) | PostHeight(mm) | Total Length (mm) | Cuff Height(mm) | Angulation(°) | Surface |
|---|---|---|---|---|---|---|
| DualAbutment | 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 | - | TiNcoating |
| HealingAbutment | 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/TiNcoating |
| AbutmentScrew | 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:
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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. | SubjectDevice | ImplantableDiameters (mm) | CompatibleImplants (510kNo.)/Manufacture | Type of Implant -AbutmentConnection/Diameter (mm) | ImplantPlatformType | ImplantPlatformDiameters(mm) | Implant BodyDiameters(mm) |
|---|---|---|---|---|---|---|---|
| 1. | DualAbutment | Ø4.0, 4.6 | ChaorumImplant 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 | MEDIMECCACO., 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. | HealingAbutment | 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. | AbutmentScrew | 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
<Substantial Equivalence to Predicate device Table – TDS (TECHWIN DENTAL SYSTEM)>
| SUBJECT Device | Primary PREDICATE Device(K160536) | SignificantDifference | |
|---|---|---|---|
| Manufacturer | TECHWIN Co., Ltd. | Medimecca Co., Ltd. | - |
| Trade Name | TDS (TECHWIN DENTAL SYSTEM) | Chaorum Implant System | - |
| RegulationDescription | Endosseous Dental Implant System | Endosseous Dental Implant System | - |
| RegulationNumber | 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 DENTALSYSTEM) are prefabricatedprosthetic components for directconnection to endosseous dentalimplants and are intended to beused as an aid in prostheticrehabilitation. It is intended for usein edentulous and partiallyedentulous patients with | Chaorum Implant System isintended for use in partially or fullyedentulous mandibles and maxilla,in support of single of multiple-unitrestorations including; cementedretained, screw retained, oroverdenture restorations, andterminal or intermediate abutmentsupport for fixed bridgework. | Similarities |
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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) | SignificantDifference | |
|---|---|---|---|
| established bone and completedgrowth period to support singleunit prosthetic restorations in themandible or maxilla. It is intendedfor one-stage and two-stagesurgical procedures. This system isintended for delayed loading. | Chaorum Implant System is forsingle stage and two stage surgicalprocedures. This system isintended 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 |
| ConnectionInterface | Hex, Non-hex | Hex, Non-hex | No difference |
| SurfaceTreatment | TiN Coating | TiN Coating | No difference. |
| Sterilization | Non-sterile; Steam sterilizationprior to use | Non-sterile; Steam sterilizationprior to use | No difference. |
| SingleUse Only | Single use Only | Single use Only | No difference. |
| SUBJECT Device | Primary PREDICATE Device(K160536) | SignificantDifference | |
| Biocompatibility | Biocompatible according to ISO10993-1 | Biocompatible according to ISO10993-1 | 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. Theabutment gingival height range of the subject device falls within the range of the predicatedevice, and the minor differences in diameter and post height are intended to meetindividual patient needs without compromising performance or safety. The 4.0 mmminimum abutment post height of the subject device, compared to the 4.5 mm of thepredicate device, allows for greater flexibility to accommodate patient-specific anatomicalvariations 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 arewell-established in dental implant applications, with Ti-6AI-4V ELI offering improvedmechanical properties and biocompatibility. The connection interface remains the samebetween 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) | SignificantDifference | |
| : 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 |
| SurfaceTreatment | Non/TiN Coating | TiN Coating | Similarities |
| Sterilization | Non-sterile; Steam sterilizationprior to use | Non-sterile; Steam sterilizationprior to use | No difference. |
| SingleUse/Reuse | Single use Only | Single use Only | No difference. |
| Biocompatibility | Biocompatible according to ISO10993-1 | Biocompatible according to ISO10993-1 | 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) | SignificantDifference | |
| 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. |
| InterfaceSurface | Machined | Machined | No difference. |
| TreatmentSterilization | Non-sterile; Steam sterilizationprior to use | Non-sterile; Steam sterilizationprior to use | No difference. |
| SingleUse/Reuse | Single use Only | Single use Only | No difference. |
| Biocompatibility | Biocompatible according to ISO10993-1 | Biocompatible according to ISO10993-1 | No difference. |
| SUBJECT Device | Primary PREDICATE Device (K160536) | SignificantDifference | |
| 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. |
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ng Expert Group
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TECHWIN Co., Ltd Traditional 510(k) Premarket Submission
TDS (TECHWIN DENTAL SYSTEM) K231932
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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.
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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.
§ 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.)