TS Abutment System

K233194 · Osstem Implant Co., Ltd. · NHA · Feb 20, 2024 · Dental

Device Facts

• Record ID: K233194
• Device Name: TS Abutment System
• Applicant: Osstem Implant Co., Ltd.
• Product Code: NHA · Dental
• Decision Date: Feb 20, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OSSTEM Abutment system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

Device Story

TS Abutment System consists of various titanium alloy (Ti-6Al-4V) or titanium (Gr.3/Gr.4) components, including rigid, transfer, angled, freeform, temporary, multi, convertible, port, stud, and healing abutments. These devices are used by dental professionals in clinical settings to connect dental implants to prosthetic restorations. The abutments provide the necessary interface for crowns, bridges, or overdentures. Some components are provided sterile (radiation) while others are intended for end-user sterilization. The system is used to maintain soft tissue shape, adjust prosthetic paths, or support screw-retained/cement-retained restorations. The device benefits patients by enabling the functional and aesthetic restoration of missing teeth through implant-supported prosthetics.

Clinical Evidence

No clinical studies were submitted. Substantial equivalence is supported by non-clinical bench testing, including fatigue testing (ISO 14801), biocompatibility evaluation (ISO 10993-1), and MRI compatibility assessment based on scientific rationale and published literature.

Technological Characteristics

Materials: Ti-6Al-4V (ASTM F136) and Titanium Gr.3/Gr.4 (ASTM F67). Sensing/Actuation: None (mechanical). Energy: None. Connectivity: None. Sterilization: Gamma radiation or end-user sterilization. Form factor: Various abutment geometries (rigid, angled, multi, etc.) for dental implant connection.

Indications for Use

Indicated for use with dental implants to support prosthetic restorations (crowns, bridges, overdentures) in partially or fully edentulous patients.

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

• Osstem Abutment System (K182091)
• Osstem Abutment System (K221684)
• External Hex Implants (K163634)
• OSSTEM Implant System - Abutment (K161689)
• OSSTEM Implant System (K161604)
• ET/SS IMPLANT SYSTEM (K120847)

Submission Summary (Full Text)

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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 and Human Services logo. To the right of that 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.

February 20, 2024

Osstem Implant Co., Ltd. % Peter Lee RA/QA Manager Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030

Re: K233194

Trade/Device Name: TS Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: Class II Product Code: NHA Dated: November 22, 2023 Received: November 22, 2023

## Dear Peter Lee:

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 ([e-mail]) or phone [phone] 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) K233194

Device Name TS Abutment System

### Indications for Use (Describe)

The OSSTEM Abutment system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

Type of Use (Select one or both, as applicable)

| <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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## 510(k) Summary K233194

## Date: February 16, 2024

## 1. Company and Correspondent making the submission

| Submitter's Name | : Osstem Implant Co., Ltd. |
|----------------------|----------------------------------------------------------------------------------|
| Address | : 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan,<br>48002, Republic of Korea |
| Contact | : Ms. Seungju Kang |
| Phone | : [phone] |
| Correspondent's Name | : Hiossen Inc. |
| Address | : 85 Ben Fairless Dr. Fairless Hills, PA 19030 |
| Contact | : Mr. Peter Lee |
| Phone | : [phone] |

## 2. Proposed Device

| Trade or (Proprietary) Name | : TS Abutment System |
|-----------------------------|--------------------------------------|
| Classification Name | : Endosseous dental implant Abutment |
| Regulation Number | : 21 CFR 872.3630 |
| Devce Classification | : Class II |
| Classification Product Code | : NHA |

## 3. Predicated Device

| Primary Predicate | |
|-------------------|----------------------------------|
| K182091 | Osstem Abutment System |
| Reference Device | |
| K221684 | Osstem Abutment System |
| K163634 | External Hex Implants |
| K161689 | OSSTEM Implant System - Abutment |
| K161604 | OSSTEM Implant System |
| K120847 | ET/SS IMPLANT SYSTEM |

## 4. Indication for use

The OSSTEM Abutment system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

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Image /page/5/Picture/2 description: The image contains the logo for Osstem Implant. The logo is in orange and the word "Osstem" is in a larger font than the word "Implant." The logo is simple and modern.

## 5. Device Description

TS Abutment System is made of titanium alloy. TS Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. TS Abutment System is similar to other commercially available products based on the intended use, technology used, material composition employed and performance characteristics.

| Device | Content | | | |
|-----------------------|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Rigid Abutment | Description | It is used for making general cement-type prosthesis. | | |
| | Material | Ti-6Al-4V (ASTM F136) | | |
| | Dimension (mm) | D(Ø)<br>4.0<br>4.6<br>5.0 | G/H<br>6.0, 7.0<br>6.0, 7.0<br>6.0, 7.0 | |
| Transfer Abutment | Description | It is used for making general cement-type prosthesis. | | |
| | Material | Ti-6Al-4V (ASTM F136) | | |
| | Dimension (mm) | D(Ø)<br>4.0<br>4.6<br>5.0<br>6.0<br>7.0 | G/H<br>1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0<br>1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0<br>1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0<br>1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0<br>1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 | |
| | Angled Abutment | Description | It is used for making general cement-type prosthesis. | |
| | | Material | Ti-6Al-4V (ASTM F136) | |
| Dimension (mm) | | D(Ø)<br>4.0<br>4.5<br>5.0<br>6.0 | G/H<br>2.0, 4.0<br>2.0, 4.0<br>2.0, 4.0<br>2.0, 4.0 | |
| Angle(°) | | 17 | | |
| FreeForm ST Abutment | | Description | It is used for making general cement-type prosthesis. | |
| | | Material | Ti-6Al-4V (ASTM F136) | |
| | Dimension (mm) | D(Ø)<br>5.5 | G/H<br>1.5, 3.0 | |
| | Description | It is used temporarily to maintain esthetic appearance and chew ability until final prosthesis is made. | | |
| Temporary Abutment | Material | Titanium Gr.3 (ASTM F67) | | |
| | Dimension (mm) | D(Ø) | G/H | Post |
| | | 4.0 | 7.0 | 10.0 |
| | | 4.5 | 7.0 | 10.0 |
| Multi Abutment | Description | It is used for edentulous mandible or maxilla and usually used to make full denture. | | |
| | Material | Ti-6Al-4V (ASTM F136) | | |
| | Dimension (mm) | D(Ø) | G/H | Post |
| | | 4.8 | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 | 2.3 |
| Multi Angled Abutment | Description | TS Multi Angled Abutment is used to adjust the path of prosthesis in the case where the path is misaligned. It is provided as a set product composed with abutment, screw, and carrier to the end users for their convienience. | | |
| | Material | Ti-6Al-4V (ASTM F136) | | |
| | Dimension (mm) | D(Ø) | G/H | Post |
| | | 4.9 | 2.5, 3.0, 3.5, 4.0, 5.0 | 2.3 |
| | Angle( °) | 17°, 30° | | |
| Convertible Abutment | Description | It is used for creating bridge case prosthesis with dislocated path. | | |
| | Material | Ti-6Al-4V (ASTM F136) | | |
| | Dimension (mm) | D(Ø) | G/H | Post |
| | | 4.0 | 1.0, 2.0, 3.0, 4.0 | 1.0 |
| | | 4.8 | 1.0, 2.0, 3.0, 4.0, 5.0 | 1.2 |
| | | 6.0 | 1.0, 2.0, 3.0, 4.0, 5.0 | 1.2 |
| Ti Cylinder Screw | Description | It is used to make final prosthesis using Convertible Abutment. | | |
| | Material | Ti-6Al-4V (ASTM F136) | | |
| | Dimension (mm) | D(Ø) | L | |
| | | 2.2 | 4.35 | |
| | | 2.5 | 4.9 | |
| Port Abutment | Description | It is used for prosthetic restoration. It is for implant retained overdenture at maxilla/mandible in case of the patient has no teeth. | | |
| | Material | Ti-6Al-4V (ASTM F136) | | |
| | Dimension<br>(mm) | D(Ø) | G/H | Post |
| Stud Abutment | Dimension<br>(mm) | 3.7 | 1.0, 2.0, 3.0, 4.0, 5.0,<br>6.0, 7.0 | 1.5 |
| | Description | It is used for prosthetic restoration. It is used for making stud<br>type overdenture prosthetics. | | |
| | Material | Ti-6Al-4V (ASTM F136) | | |
| | Dimension<br>(mm) | D(Ø)<br>3.5 | G/H<br>1.0, 2.0, 3.0, 4.0, 5.0,<br>6.0 | Post<br>2.5, 3.35 |
| | Description | It is used to make a natural soft tissue shape before setting up<br>prosthetics and removing cover screw after osseointegration. | | |
| | Material | Titanium Gr.4 (ASTM F67) | | |
| Healing Abutment | Dimension<br>(mm) | D(Ø)<br>4.3<br>4.8<br>5.3<br>6.3<br>7.3<br>8.3<br>9.3 | L<br>2.0, 6.0, 8.0<br>6.0, 8.0, 10.0<br>6.0, 8.0, 10.0, 11.0, 12.0<br>6.0, 8.0<br>6.0, 8.0<br>6.0, 8.0<br>5.0, 6.0, 8.0 | |

The specifications of the proposed device are as follow;

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Image /page/6/Picture/2 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a stylized font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern.

OSSTEM Implant Co., Ltd.
66-16, Bansong-n 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: [phone] Fax: [phone] www.osstem.com.

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Image /page/7/Picture/2 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a stylized font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern.

OSSTEM Implant Co., Ltd.
66-16, Bansong-n 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: [phone] Fax: [phone] www.osstem.com.

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Image /page/8/Picture/2 description: This image shows the logo and contact information for OSSTEM Implant Co., Ltd. The address is 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea. The telephone number is [phone], the fax number is [phone], and the website is www.osstem.com.

## 6. Substantial Equivalence Matrix

These subject devices are modifications to are cleared in past 510(k); therefore, indication for use, shape, comection structure, material, surface treatment, manufacturer and etc. are the same with predicated devices except dimension of additional products.

## 1.1 Non-Sterile Device

1) Rigid Abutment

| | Subject Device | Reference Device | Primary Predicate | Remark | |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|------|
| Device Name | Rigid Abutment | Rigid Abutment | Transfer Abutment | Same | |
| 510(k) Number | - | K161689 | K182091 | - | |
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same | |
| Design | Image: Subject Device Design | Image: Reference Device Design | Image: Primary Predicate Design | Same | |
| Indication for Use | The OSSTEM Abutment system is<br>intended for use with a dental implant to<br>provide support for prosthetic<br>restorations such as crowns, bridges, or<br>overdentures. | The OSSTEM Implant System -<br>Abutment is intended for use with a<br>dental implant to provide support for<br>prosthetic restorations such as crowns,<br>bridges, or overdentures. | Osstem Abutment System is intended for<br>use with a dental implant to provide<br>support for prosthetic restorations such<br>as crowns, bridges, or overdentures. | Same | |
| Principle of<br>Operation | Using making for general cement-type<br>prosthesis. | Using making for general cement-type<br>prosthesis. | Using making for general cement-type<br>prosthesis. | Same | |
| | | | | | |
| Dimension (mm) | D(Ø) | G/H | Post | | |
| | 4.0 | 6.0, 7.0 | 5.5 | | |
| | 4.6 | 6.0, 7.0 | 5.5 | | |
| | 5.0 | 6.0, 7.0 | 4.0, 5.5 | | |
| | | | | | |
| | D(Ø) | G/H | Post | | |
| | 4.0 | 1.0, 2.0, 3.0,<br>4.0, 5.0 | 4.0, 5.5,<br>7.0 | | |
| | 4.6 | 1.0, 2.0, 3.0,<br>4.0, 5.0 | 4.0, 5.5,<br>7.0 | | |
| | 5.0 | 1.0, 2.0, 3.0,<br>4.0, 5.0 | 4.0, 5.5,<br>7.0 | | |
| | 6.0 | 1.0, 2.0, 3.0,<br>4.0, 5.0 | 4.0, 5.5,<br>7.0 | | |
| | 7.0 | 1.0, 2.0, 3.0,<br>4.0, 5.0 | 5.5 | | |
| | | | | | |
| | D(Ø) | G/H | Post | | |
| | 4.0 | 1.0, 2.0, 3.0,<br>4.0, 5.0, 6.0,<br>7.0 | 5.5, 7.0 | Different | |
| | 4.6 | 1.0, 2.0, 3.0,<br>4.0, 5.0, 6.0,<br>7.0 | 5.5, 7.0 | | |
| | 5.0 | 1.0, 2.0, 3.0,<br>4.0, 5.0, 6.0,<br>7.0 | 4.0, 5.5,<br>7.0 | | |
| | 6.0 | 1.0, 2.0, 3.0,<br>4.0, 5.0, 6.0,<br>7.0 | 4.0, 5.5,<br>7.0 | | |
| | 7.0 | 1.0, 2.0, 3.0,<br>4.0, 5.0, 6.0,<br>7.0 | 4.0, 5.5 | | |
| Material | Titanium Alloy (ASTM F136) | | | Titanium Alloy (ASTM F136) | Same |
| Surface<br>Treatment | N/A…