Osstem Abutment System
Device Facts
| Record ID | K221684 |
|---|---|
| Device Name | Osstem Abutment System |
| Applicant | Osstem Implant Co., Ltd. |
| Product Code | NHA · Dental |
| Decision Date | Sep 8, 2022 |
| 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
Osstem Abutment System consists of dental abutments and screws used to connect prosthetic restorations (crowns, bridges, overdentures) to endosseous dental implants. Components include TS Multi Angled Abutments, US Esthetic-low Abutments, and TS Temporary Abutments. Devices are manufactured from Titanium Alloy (ASTM F136) or Titanium (ASTM F67). The system is used by dental clinicians in a clinical setting to adjust prosthetic paths, facilitate screw-retained aesthetics, or maintain temporary aesthetics during healing. The clinician attaches the abutment to the fixture and secures it with a screw. The output is a stable interface between the implant and the final or temporary prosthesis, benefiting the patient by restoring dental function and aesthetics. The device is provided non-sterile and requires end-user sterilization via moist heat.
Clinical Evidence
No clinical data provided. Substantial equivalence is supported by non-clinical performance testing, including biocompatibility evaluation (per ISO 10993-1), mechanical fatigue testing (per ISO 14801 and FDA guidance), and MR compatibility assessment based on scientific literature.
Technological Characteristics
Materials: Titanium Alloy (ASTM F136) and Titanium (ASTM F67). Connection types: Internal Hex and External Hex. Dimensions vary by model (diameters 2.71mm–7.1mm; heights 2.1mm–10.9mm). Provided non-sterile; intended for moist heat sterilization by the end-user. No software or electronic components.
Indications for Use
Indicated for patients requiring prosthetic restoration support (crowns, bridges, or overdentures) via dental implants.
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 (K160670)
Reference Devices
- ET US SS Prosthetic System (K160670)
Related Devices
- K161689 — OSSTEM Implant System - Abutment · Osstem Implant Co., Ltd. · May 22, 2017
- K231874 — AOT & T-L Abutment · Truabutment, Inc. · Oct 30, 2023
- K233194 — TS Abutment System · Osstem Implant Co., Ltd. · Feb 20, 2024
- K160670 — ET US SS Prosthetic system · Osstem Implant Co., Ltd. · Apr 25, 2017
- K222636 — ET Abutment System · Hiossen, Inc. · Apr 28, 2023
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
Osstem Implant Co., Ltd. % Peter Lee RA/QA Manager HiOSSEN Inc. 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030
### Re: K221684
Trade/Device Name: Osstem Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 9, 2022 Received: June 10, 2022
### 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 (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 located 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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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.
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 Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K221684
Device Name OSSTEM 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*)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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public of Korea 513beon-gil Haeundae-gu Busan Re +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
## 510(k) Summary
### Date: September 8, 2022
#### 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 | : +82-51-850-2500 |
| - | Correspondent's Name | : Hiossen Inc. |
| - | Address | : 85 Ben Fairless Dr. Fairless Hills, PA 19030 |
| - | Contact | : Mr. Peter Lee |
| - | Phone | : +1-267-759-7031 |
## 2. Proposed Device
| Trade or (Proprietary) Name | : Osstem Abutment System |
|-----------------------------|--------------------------------------|
| Classification Name | : Endosseous dental implant abutment |
| Regulation Number | : 21CFR872.3630 |
| Devce Classification | : Class II |
| Classification Product Code | : NHA |
### 3. Predicated Device
Primary Predicate K182091 Osstem Abutment System
Reference Device
ET US SS Prosthetic System, Osstem Implant Co., Ltd. K160670
## 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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## 5. Device Description
Osstem Abutment System is compatible with the following implant systems.
| Manufacturer | Model Name | Connection | Diameter (mm) |
|--------------------------|---------------|--------------|----------------------------------------------------------------------------------------------------------------------|
| Osstem Implant Co., Ltd. | TS SA Fixture | Internal Hex | 3.2, 3.5, 3.75, 3.77, 4.2, 4.25, 4.4, 4.6, 4.63, 4.65, 4.8, 4.9, 5.05, 5.08, 5.1, 5.25, 5.92, 5.95, 6, 6.2, 6.8, 7.1 |
| Osstem Implant Co., Ltd. | US SA Fixture | External Hex | 3.6, 4.2, 5.1, 5.2 |
Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Osstem Abutment System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.
Osstem Abutment System is substaintially equivalent in design, function and intended use to the predicate devices as above.
| Device | Content | |
|--------------------------------|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| TS Multi Angled Abutment | Description | TS Multi Angled Abutment is used to adjust the path of prosthesis in the case where the path is misaligned. |
| | Material | Titanium Alloy (Ti-6Al-4V, ASTM F136) |
| | Diameter (mm) | 4.9 |
| | Height (mm) | 5, 5.1, 5.5, 5.6, 6, 6.1, 6.5, 6.6, 7.5, 7.6 |
| | Angulation | 17°, 30° |
| US Esthetic-low Abutment | Description | Used in producing screw-retained aesthetic prosthetics. Structure producing prosthetics in cylinder after attaching abutment in the oral cavity.<br>US Esthetic-low Abutment Set is consisted of US Esthetic-low Abutment and Esthetic-low Abutment Screw. |
| | Material | Titanium (ASTM F67) |
| | Diameter (mm) | 4.8, 5.5 |
| | Height (mm) | 2.1, 2.2, 3.0, 3.1, 4.0, 4.1, 5.0, 5.1 |
| US Esthetic-low Abutment Screw | Description | Used to connect US Esthetic-low abutment with fixture. |
| | Material | Titanium (ASTM F67) |
| | Diameter (mm) | 3.1, 3.6 |
| | Height (mm) | 7.8, 7.9, 8.8, 8.9, 9.8, 9.9, 10.8, 10.9 |
| TS Temporary Abutment | Description | TS Temporary Abutment is used for prosthetic restoration. It is used temporarily to maintain |
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Image /page/5/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in orange, with a small superscript "6" next to the "M". Below "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and modern.
Osstem Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
| | esthetic appearance until final prosthesis is made. |
|---------------|-----------------------------------------------------|
| Material | Titanium Gr.3 (ASTM F67) |
| Diameter (mm) | 4.0, 4.5 |
| G/H (mm) | 1.0, 3.0 |
## 6. Substantial Equivalence Matrix
These subject devices are cleared in past 510(k); therefore, indication for use, shape, connection structure, material, surface treatment, manufacturer and etc. are the same with predicated devices except dimension of additional products.
| | Proposed Devices | Predicated Devices | Remark |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Device Name | TS Multi Angled Abutment | TS Multi Angled Abutment | Same |
| 510(k) No. | Proposed | K182091 | Same |
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Same |
| Design | Image: Proposed Device Design | Image: Predicated Device Design | Same |
| Indications for Use | The Osstem Abutment<br>System is intended for use<br>with a dental implant to<br>provide support for<br>prosthetic restorations such<br>as crowns, bridges, or<br>overdentures. | The Osstem Abutment<br>System is intended for use<br>with a dental implant to<br>provide support for<br>prosthetic restorations such<br>as crowns, bridges, or<br>overdentures. | Same |
| Principle of<br>Operation | Using making screw-<br>retained type prosthesis in<br>multiple cases by using with<br>Esthetic-low cylinder when<br>path adjustment is<br>necessary. | Using making screw-<br>retained type prosthesis in<br>multiple cases by using with<br>Esthetic-low cylinder when<br>path adjustment is<br>necessary. | Same |
| Material | Ti-6Al-4V (ASTM F136) | Ti-6Al-4V (ASTM F136) | Same |
| Abutment Angle (°) | 17 | 17, 30 | Same |
| Platform(Ø) | 4.9mm | 4.9mm | Same |
| Connection | Hex | Hex | Same |
| Gingival Height | 5.0mm | 2.5~4.0mm (17°)<br>2.5~5.0mm (30°) | 5.0mm is<br>added; within<br>the range of the<br>predicates |
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Image /page/6/Picture/0 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. A small superscript "o" is located to the right of the word "OSSTEM".
**Osstem Implant Co., Ltd.**
OSSTEM Implant Co., Ltd..
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
| S.E. | <b>Similarities</b><br>Proposed Multi Angled Abutment has same design, fuction and indication for<br>use; and is made with same material with same manufacturing method by same<br>manufacturer compared to that of the predicated Multi Angled Abutment<br>(K182091). |
|------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <b>Differences</b><br>Proposed Multi Angled Abutment has same diameter, length and angulation<br>that is smaller than predicated Multi Angled Abutment. But the angulation is<br>included in predicated product, and we have already completed the fatigue test<br>for the larger angulation according to the FDA Guidance <i>Class II Special<br/> Controls Guidance Document: Root-form Endosseous Dental Implants and<br/> Endosseous Dental Implant Abutments</i> .Therefore, we didn't conduct additional<br>fatigue testing. |
| | ... Proposed Multi Angled Abutment and the predicated Multi Angled<br>Abutment have common in design, function, indications for use, material,<br>manufacturing process, manufacturer, etc.; therefore, the proposed Multi<br>Angled Abutment is substantially equivalent to the predicated Multi Angled<br>Abutment (K182091). |
| | Proposed Devices | Predicated Devices | Remark |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Device Name | US Esthetic-low Abutment | US Esthetic-low Abutment | Same |
| 510(k) No. | Proposed | K160670 | Same |
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Same |
| Design | Image: Proposed Design | Image: Predicated Design | Same |
| Indications for Use | The Osstem Abutment<br>System is intended for use<br>with a dental implant to<br>provide support for<br>prosthetic restorations such<br>as crowns, bridges, or<br>overdentures. | The OSSTEM Prosthetic<br>system is intended for use<br>with a dental implant to<br>provide support for<br>prosthetic restorations such<br>as crowns, bridges, or over-<br>dentures. | Same |
| Principle of<br>Operation | Esthetic-low abutment is<br>connected to implanted<br>fixture and upper part is<br>connected to cylinder<br>Esthetic-low abutment uses<br>cylinder screw to fasten<br>screw-retained type | Esthetic-low abutment is<br>connected to implanted<br>fixture and upper part is<br>connected to cylinder<br>Esthetic-low abutment uses<br>cylinder screw to fasten<br>screw-retained type | Same |
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Image /page/7/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. There is a small superscript "6" next to the word "OSSTEM".
**Osstem Implant Co., Ltd.**
Osstem Implant Co., ILtd..
66-16, Bansong-ro 513beon-gil, Haeunda-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
| | prosthesis | prosthesis | |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-----------|
| | | | |
| Material | Ti CP Gr3 (ASTM F67) | Ti CP Gr3 (ASTM F67) | Same |
| Diameter(Ø) | 2.71mm | 2.41mm, 2.71mm, 3.41mm | Same |
| Length(mm) | 5.0mm | 1.1~4.1mm | Differnet |
| Connection | External Hex Connection | External Hex Connection | Same |
| S.E. | Similarities<br>Proposed Esthetic-low Abutment has same design, fuction and indication for use; and is made with same material with same manufacturing method by same manufacturer compared to that of the predicated Esthetic-low Abutment (K160670).<br><br>Differences<br>Proposed Esthetic-low Abutment has total length is bigger than predicated Esthetic-low Abutment. In order to consider the fatigue performance of the Esthetic-low Abutment, we take into an account whether the proposed device is chosen as a worst-case compared to predicated device.<br><br>First of all, to compare the diameter of the compatible implant fixture, we choose the MEM400 as worst case from the predicate devices since it has the smallest diameter and mini connection.<br><br>Secondly, the diameter of compatible implant fixture to the proposed device, which has regular connection, is 4.20mm and bigger than the diameter of compatible implant fixture to the predicate device, MEM400, which 3.75mm and has mini connection. Also, total length is not affected to choose a worst case because moment arm is not changed. The distance between the embedding plane and the centre of the hemispherical loading member always is 11mm according to the ISO14801.<br><br>As a result, the fatigue of the proposed device is considered to be equal to or greater than that of the predicated device. Therefore, we didn't conduct additional fatigue testing. | | |
| | ... Proposed Esthetic-low Abutment and the predicated Esthetic-low Abutment have common in design, function, indications for use, material, manufacturing process, manufacturer, etc.; therefore, the proposed Esthetic-low Abutment is substantially equivalent to the predicated Esthetic-low Abutment (K160670). | | |
| | Proposed Devices | Predicated Devices | Remark |
|--------------|-----------------------------------|-----------------------------------|--------|
| Device Name | US Esthetic-low Abutment<br>Screw | US Esthetic-low Abutment<br>Screw | Same |
| 510K No. | Proposed | K160670 | Same |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. | Same |
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Image /page/8/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with the "O" being slightly larger than the other letters. The word "IMPLANT" is written in gray below "OSSTEM". The logo is simple and modern.
**Osstem Implant Co., Ltd.**
OSSTEM® OSSTEM IImplant CO., Ltd..
66-16, Bansong-ro 513beon-gil, Haeunda-gu, Busan, Republic of Korea
. . . . . . Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.oom
| Design | Image: Abutment Screw | Image: Abutment Screw | Same |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Indication for Use | The Osstem Abutment<br>System is intended for use<br>with a dental implant to<br>provide support for<br>prosthetic restorations such<br>as crowns, bridges, or<br>overdentures. | The OSSTEM Prosthetic<br>system is intended for use<br>with a dental implant to<br>provide support for<br>prosthetic restorations such<br>as crowns, bridges, or over-<br>dentures. | Same |
| Principles of<br>Operation | Esthetic-low Abutment<br>Screw is fasten Esthetic-low<br>Abutment to Implanted<br>fixture | Esthetic-low Abutment<br>Screw is fasten Esthetic-low<br>Abutment to Implanted<br>fixture | Same |
| Material | Ti-6Al-4V (ASTM F136) | Ti-6Al-4V (ASTM F136) | Same |
| Diameter(Ø) | 3.1mm | 3.1mm, 3.6mm | Same |
| Length(mm) | 11.8mm | 7.9~10.8mm | Different |
| S.E. | Similarities<br>Proposed Esthetic-low Abutment Screw has same design, function and<br>indication for use; and is made with same material with same manufacturing<br>method by same manufacturer compared to that of the predicated Esthetic-low<br>Abutment Screw (K160670).<br>Differences<br>Proposed Esthetic-low Abutment Screw has new dimension of total length.<br>.:. Proposed Esthetic-low Abutment Screw and the predicated Esthetic-low<br>Abutment Screw have common in design, function, indications for use,<br>material, manufacturing process, manufacturer, etc.; therefore, the proposed<br>Esthetic-low Abutment Screw is substantially equivalent to the predicated<br>Esthetic-low Abutment Screw (K160670). | | |
| | Proposed Devices | Predicated Devices | Remark |
|--------------|--------------------------|--------------------------|--------|
| Device Name | TS Temporary Abutment | TS Temporary Abutment | Same |
| 510K No. | Proposed | K182091 | - |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. | Same |
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Image /page/9/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in orange, with a stylized font. Below it, the word "IMPLANT" is in gray and in a smaller font. The logo is simple and clean, with a focus on the company name.
**Osstem Implant Co., Ltd.**
OSSTEM® OSSTEM IImplant CO., Ltd..
66-16, Bansong-ro 513beon-gil, Haeunda-gu, Busan, Republic of Korea
. . . . . . Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.oom
| Design | Image: Dental Implant | Image: Dental Implant | Same except<br>for its shape<br>of the hex |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Indication for Use | The Osstem Abutment System<br>is intended for use with a<br>dental implant to provide<br>support for prosthetic<br>restorations such as crowns,<br>bridges, or overdentures. | The Osstem Abutment<br>System is intended for use<br>with a dental implant to<br>provide support for<br>prosthetic restorations such<br>as crowns, bridges, or<br>overdentures. | Same |
| Principle of<br>Operation | Using making temporary<br>prosthesis to maintain<br>aesthetic appearance until<br>final prosthesis is made. | Using making temporary<br>prosthesis to maintain<br>aesthetic appearance until<br>final prosthesis is made. | Same |
| Material | Ti CP Gr3 (ASTM F67) | Ti CP Gr3 (ASTM F67) | Same |
| Diameter(Ø) | 4.0, 4.5mm | 4.0, 4.5mm | Same |
| Post Height (mm) | 10 | 10 | Same |
| Hex Size | 2.08, 2.48mm | 2.08, 2.48mm | Same |
| Appearance | Image: Dental Implant with Hex Part | Image: Dental Implant with Hex Part | Different |
| S.E. | Similarities<br>Proposed Temporary Abutment has same design (except for its shape of hex),<br>function and indication for use; and is made with same material with same<br>manufacturing method by same manufacturer compared to that of the<br>predicated Temporary Abutment (K182091)<br>Differences<br>Shape of the hex between the proposed and predicated Temporary Abutment is<br>different. But the hex size that is connected to fixture is same although there is<br>difference of design of hex compared with predicated product. In addition,<br>since Temporary Abutment is used to make temporary prosthesis for esthetic<br>purpose for healing period after placement of fixture, changing the shape of<br>hex does not affect the any performance. Therefore, we do not need to consider<br>fatigue testing. | | |
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a small superscript "6" next to the "M". Below "OSSTEM", the word "IMPLANT" is written in gray. The logo is simple and modern.
Osstem Implant Co., Ltd
16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea el: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
> : . While shape of the hex of Temporary Abutment is changed compared to the predicates, proposed Temporary Abutment and the predicated Temporary Abutment have common in design, function, indications for use, material, manufacturing process, manufacturer, etc .; therefore, the proposed Temporary Abutment is substantially equivalent to the predicated Temporary Abutment (K182091).
#### 7. Summary of Non-clinical Performance Testing
Non-clinical testing data are submitted to demonstrate substantial equivalence.
#### Biocompatibility Evaluation
Biocompatibility testing was considered followed 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, " The Osstem Abutment System has same materials, manufacturer, manufacturing process etc., as predicate device and reference devce. Therefore, we didn't conduct additional biocompatibility test.
#### Sterilization Validation and Shelf-life
Proposed devices are provided to the market in non-sterile. The proposed devices are enduser sterilized by moist heat with the same parameters as the primary predicate. The Osstem Abutment System has same materials, manufacturer, manufacturing process etc., as predicate device and reference device. Therefore, we didn't conduct additional sterilization validation.
#### Mechanical Properties
Fatigue testing was considered according to the FDA Guidance Document Guidance for Industry and FDA Staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment and ISO 14801 standard with the worst case scenario. First of all, gingival height of proposed TS Multi Angled Abutment is large than predicate device at the same angle. But the predicate device with the same gingival height has a larger angle. Secondly, proposed US Esthetic-low Abutment which has regular connection has bigger total length than predicate deivce. But predicate device has mini connection and total length is not affected to choose a worst case. Finally, TS Temporary Abutment has same hex size that is connected to implant although there is difference of design of hex compared with predicate device. In addition, TS Temporary Abutment is used temporarily during healing period. Therfore, we didn't conduct additional fatigue test because the proposed device is not worst-case.
#### MR Compatibility
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 fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling
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Image /page/11/Picture/0 description: This image contains the logo and contact information for Osstem Implant Co., Ltd. The logo includes the company name in bold, along with the word "IMPLANT" in a smaller font. The address is listed as 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea. The image also includes the telephone number +82 51 850 2500, fax number +82 51 861 4693 and website www.osstem.com.
Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
## 8. Summary of Clinical Testing
No clinical studies are submitted.
#### 9. Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, Osstem Implant Co., Ltd. concludes that Osstem Abutment System is substantially equivalent to the predicated devices as herein.
