Who is the manufacturer of TDS (TECHWIN DENTAL SYSTEM)?

Techwin Co., Ltd. filed the 510(k) submission for TDS (TECHWIN DENTAL SYSTEM) (K231932).

What is the FDA product code for TDS (TECHWIN DENTAL SYSTEM)?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for TDS (TECHWIN DENTAL SYSTEM)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for TDS (TECHWIN DENTAL SYSTEM)?

Chaorum Implant System (K160536).

Who can help prepare an FDA 510(k) submission like TDS (TECHWIN DENTAL SYSTEM)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

TDS (TECHWIN DENTAL SYSTEM)

K231932 · Techwin Co., Ltd. · NHA · Aug 20, 2024 · Dental

Device Facts

Record ID	K231932
Device Name	TDS (TECHWIN DENTAL SYSTEM)
Applicant	Techwin Co., Ltd.
Product Code	NHA · Dental
Decision Date	Aug 20, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Intended 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 two-stage surgical procedures. This system is intended for delayed loading.

Device Story

TDS (TECHWIN DENTAL SYSTEM) consists of prefabricated prosthetic components (Dual Abutment, Healing Abutment, Abutment Screw) for connection to endosseous dental implants. Used in dental clinics by clinicians for prosthetic rehabilitation in edentulous/partially edentulous patients. Components support single-unit restorations via delayed loading. Abutments are made of Ti-6Al-4V ELI alloy (ASTM F136), some with TiN coating via Arc Ion Plating. Supplied non-sterile; requires end-user steam sterilization. Device interfaces with specific third-party implants (Chaorum Implant System). Clinical benefit is the restoration of dental function and aesthetics for patients with missing teeth.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility (ISO 10993-1, -5, -6, -10, -23), surface treatment analysis (SEM, roughness, coating thickness), sterilization validation (ISO 17665), and MRI safety assessment.

Technological Characteristics

Materials: Ti-6Al-4V ELI alloy (ASTM F136). Surface: Uncoated or TiN coated (Arc Ion Plating). Connection: Hex/Non-hex internal conical. Sterilization: Steam (autoclave) by end-user. Dimensions: Various diameters, post heights, and gingival heights. Connectivity: None (mechanical component).

Indications for Use

Indicated for edentulous and partially edentulous patients with established bone and completed growth period requiring single-unit prosthetic restorations in the mandible or maxilla.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

Chaorum Implant System (K160536)

Related Devices

K233194 — TS Abutment System · Osstem Implant Co., Ltd. · Feb 20, 2024
K231874 — AOT & T-L Abutment · Truabutment, Inc. · Oct 30, 2023
K173570 — SD Abutment · Surgident Co., Ltd. · May 17, 2019
K091392 — TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK · Pou YU Biotechnology Co., Ltd. · Jul 30, 2009
K081460 — TDS ABUTMENT · Pou YU Biotechnology Co., Ltd. · Nov 21, 2008

Submission Summary (Full Text)

{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 | Ø3.25~3.89 | MEDIMECCA CO., LTD. | | | | System | | Regular | Ø3.89~6.28 | | | 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 <Substantial Equivalence to Predicate device Table – TDS (TECHWIN DENTAL SYSTEM)> | | 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 | <Abutment Screw> Image: [Abutment Screw O-type] | <Abutment Screw> Image: [Abut…