OSSTEM Implant System - Abutment
Device Facts
| Record ID | K161689 |
|---|---|
| Device Name | OSSTEM Implant System - Abutment |
| Applicant | Osstem Implant Co., Ltd. |
| Product Code | NHA · Dental |
| Decision Date | May 22, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
Indications for Use
The OSSTEM Implant System - Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Device Story
The OSSTEM Implant System - Abutment consists of various abutments, components, and screws used in dental prosthetic restoration. The device connects to a dental implant fixture (e.g., TS SA Fixtures) to provide a foundation for crowns, bridges, or overdentures. Components include transfer, ZioCera, temporary, FreeForm ST, multi, stud, and custom healing abutments, along with protective caps and O-ring retainers. The device is used by dental professionals in a clinical setting. The abutment is secured to the implant fixture via an abutment screw. The output is a stable prosthetic platform that allows the clinician to attach final or temporary restorations, thereby restoring dental function and aesthetics for the patient.
Clinical Evidence
No clinical studies were submitted. Substantial equivalence is supported by non-clinical bench testing, including sterilization validation (ISO 17665-1/2 for steam, ISO 11137-1/2/3 for radiation), and leveraging biocompatibility and shelf-life data from previously cleared predicate devices.
Technological Characteristics
Materials include Titanium Alloy (ASTM F136), Zirconia, PEEK, POM, and Acrylonitrile & Butadiene Polymer. Components feature internal hex connections. Sterilization methods include steam sterilization (ISO 17665-1/2) for non-sterile components and radiation (ISO 11137) for sterile components. The system is designed for compatibility with TS Fixture Systems (K121995).
Indications for Use
Indicated for use with dental implants in partially or fully edentulous mandibles and maxillae to support single or multiple-unit prosthetic restorations, including cemented, screw-retained, or overdenture restorations, and for temporary abutment support for fixed bridgework.
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
- ET Prosthetic System (K130662)
- ET SS Implant System (K120847)
- Ziocera & Convertible System (K081786)
- TS Implant System (K121585)
- GS System (K063861)
- Prosthetic System (K110308)
- HS, HG Prosthetic System (K100245)
- Hiossen Prosthetic system (K140507)
- SS System (K062051)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 22, 2017
OSSTEM Implant Co., Ltd. c/o Mr. David Kim Manager HiOSSEN Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030
Re: K161689
Trade/Device Name: OSSTEM Implant System - Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 21, 2017 Received: April 21, 2017
Dear Mr. 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 (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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/1 description: This image contains the logo and contact information for OSSTEM Implant Co., Ltd. The logo features the company name in bold, black letters, with the word "OSSTEM" in orange on the left. Below the company name is the address: 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 51 850-4341), and website address (www.osstem.com).
### Indications for Use Statement
161689 510(k) Number K
Device Name: OSSTEM Implant System - Abutment
Indication for use:
The OSSTEM Implant System - Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Prescription Use X (Per 21CFR801 Subpart D) OR
Over-The-Counter Use (Per 21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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**OSSTEM**
IMPLANT
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
### 510(k) Summary
- 1. Date: May 19, 2017
- Submitter's Name:
- Address:
- Contact:
- Phone:
- Correspondent's Name:
- Address:
- Contact:
- Phone:
- 2. Device:
Trade or (Proprietary) Name: Common or usual name: Classification Name: Regulation Number: Device Classification: Subsequent Product Code:
OSSTEM Implant Co., Ltd. 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, 48002 Republic of Korea Mr. Hee Kwon Son +82 51 850 2575
HIOSSEN Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 DAVID KIM 267 759 7031
OSSTEM Implant System - Abutment Dental Abutment Endosseous dental implant abutment 21CFR872.3630 Class II NHA
- 3. Predicate Device:
Substantial equivalence is claimed to the following devices:
Primary Predicate K130662, ET Prosthetic System, OSSTEM IMPLANT CO., LTD
Reference predicate K120847, ET SS Implant System, OSSTEM IMPLANT CO., LTD K081786, Ziocera & Convertible System, OSSTEM IMPLANT CO., LTD K121585, TS Implant System, OSSTEM IMPLANT CO., LTD K063861, GS System, OSSTEM IMPLANT CO., LTD K110308, Prosthrtic System K100245, HS, HG Prosthetic System K140507, Hiossen Prosthetic system K062051, SS System
- 4. Description:
The OSSTEM Implant System - Abutment is intended for use as an aid in prosthetic restoration. It consists of Abutments, components and Abutment Screws.
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Image /page/4/Picture/1 description: The image shows the logo for Osstem Implant. The logo is orange and black. The word "OSSTEM" is in orange, and the word "IMPLANT" is in black. The logo is simple and modern.
Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
The OSSTEM Implant System - Abutment is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
The OSSTEM Implant System - Abutment is substantially equivalent in design, function and intended use to the Predicate Devices as above.
This submission includes straight abutments only that are not intended for any divergence/implant body angulation correction. The abutments are to be used with the TS SA Fixtures cleared in K121995.
| | Items | Content | |
|-----|-----------------------------|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) | Transfer Abutment | Material | Titanium Alloy (Ti-6Al-4V) |
| | | Diameter (mm) | 4.6, 5.0, 6.0, 7.0 |
| | | Length(mm) | 7.5, 8.5, 9, 9.1, 9.5, 10, 10.1, 10.5, 10.6, 11, 11.1,<br>11.5, 11.6, 12, 12.1, 12.5, 12.6, 13, 13.1, 13.5,<br>13.6, 14, 14.5, 14.6 |
| | | Angulation | - |
| | | Device<br>Description | Used for making general cement-type prosthesis. |
| 2) | ZioCera Abutment | Material | Zirconia |
| | | Diameter (mm) | 4.5, 5.5, 6.5 |
| | | Length(mm) | 12.3, 12.7, 12.75, 13, 14.2, 14.4, 14.5, 14.75, 14.8 |
| | | Angulation | - |
| | | Device<br>Description | Used for making general cement-type prosthesis. |
| 3) | Quick Temporary<br>Abutment | Material | Titanium Alloy(Ti-6Al-4V) +<br>PEEK (Polyetherethereketone) |
| | | Diameter (mm) | 4, 4.5 |
| | | Length(mm) | 11.5 |
| | | Angulation | - |
| | | Device<br>Description | Used temporary until final prosthesis is made. |
| 4) | FreeForm ST<br>Abutment | Material | Titanium Alloy (Ti-6Al-4V) |
| | | Diameter (mm) | 4.0, 5.0, 5.5, 6.0, 7.0 |
| | | Length(mm) | 14, 14.5, 14.6 |
| | | Angulation | - |
| | | Device<br>Description | Used for making general cement-type prosthesis.<br>Used when an abutment's path must be altered or a<br>prosthetic's margin area must be customized. |
| 5) | Multi Abutment | Material | Titanium Alloy (Ti-6Al-4V) |
| | | Diameter (mm) | 4.8 |
| | | Length(mm) | 8.3,8.7, 9.3, 9.7, 10.3, 10.7, 11.3, 11.7, 12.3, 12.7 |
| | | Angulation | - |
| | | Device<br>Description | Used for edentulous mandible or maxilla to make<br>full denture. |
| | | Material | Titanium Alloy (Ti-6Al-4V) |
| 6) | Stud Abutment | Diameter (mm) | 3.5 |
| | | Length(mm) | 9.35, 9.75, 10.35, 10.75, 11.35, 11.75, 12.35, 12.75, 13.35, 13.75, 14.35, 14.75 |
| | | Angulation | - |
| | | Device Description | Used in creating stud type overdenture prosthetics. |
| | | | Material |
| 7) | Rigid Protect Cap | Diameter (mm) | 4.4, 5.0, 5.5, 6.6, 7.4 |
| | | Length(mm) | 5.5, 5.7, 5.8, 5.9, 7.0, 7.2, 7.3, 8.5, 8.7, 8.8 |
| | | Angulation | - |
| | | Device Description | Used for the protection of the Rigid Abutment in the oral cavity. |
| | | Material | POM (Polyoxymethylene) |
| | | Diameter (mm) | 4.8, 6.0, 6.6, 7.7, 8.7 |
| 8) | Rigid Retraction Cap | Length(mm) | 5.5, 7.0, 8.5 |
| | | Angulation | - |
| | | Device Description | Used for the protection of the Rigid Abutment on the oral cavity. |
| | | Material | PEEK ( Polyetherethereketone) |
| | | Diameter (mm) | 7.05 |
| 9) | Custom Healing Abutment | Length(mm) | 7, 7.5, 9, 9.5, 11, 11.5 |
| | | Angulation | - |
| | | Device Description | Used to make a soft tissue shape before setting up prosthetics. |
| | | Material | Titanium Alloy (Ti-6Al-4V) |
| | | Diameter (mm) | 4.0, 4.6, 5.0, 6.0, 7.0 |
| | Rigid Abutment | Length(mm) | 10, 10.4, 11, 11.4, 11.5, 11.9, 12, 12.4, 12.5, 12.9, 13, 13.4, 13.5, 13.9, 14, 14.4, 14.5, 14.9, 15, 15.4, 15.5, 15.9, 16, 16.4, 17, 17.4 |
| 10) | | | Angulation |
| | | | Device<br>Description |
| | | | Material |
| | | | Diameter (mm) |
| | Temporary Abutment | Length(mm) | 13, 13.5, 13.6, 15, 15.5, 15.6 |
| 11) | | | Angulation |
| | | | Device Description |
| | | | Material |
| | | | Diameter (mm) |
| 12) | O-ring<br>Retainer Cap Set | Length(mm) | Retainer Cap: 3.9/ O-Ring: 1.5mm |
| | | | Angulation |
| | | | Device Description |
| | | | Material |
| | | | Diameter (mm) |
| 13) | | O-ring Retainer Set | Length(mm) |
| | Angulation | - | |
| | Device | Used for making stud-type overdenture. | |
| | Description | Retainer + O-ring | |
| | Material | Acrylonitrile & Butadiene Polymer | |
| | Diameter (mm) | 4.6 | |
| 14) | O-ring Set | Length(mm) 1.5 | |
| | Angulation | - | |
| | Device | Used for making stud-type overdenture. | |
| | Description | | |
| | Material | Titanium Alloy (Ti-6Al-4V) | |
| | Diameter (mm) | 2.0, 2.05, 2.2, 2.3, 2.5 | |
| 15) | Abutment Screw | Length(mm) 3.35, 5.6, 7.5, 8.35, 9.6, 10.2 | |
| | Angulation | - | |
| | Device | Used to connect an abutment with fixture. | |
| | Description | | |
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Image /page/5/Picture/0 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, italicized font. To the right of the word "OSSTEM" is a small superscript symbol.
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Image /page/6/Picture/1 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, italicized font. The logo is simple and modern, and the orange color is eye-catching.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
The OSSTEM Implant System - Abutment is compatible with TS Fixture System, K121995.
TS Fixture System (TSII SA Fixture, TSIII SA Fixture, TSIII Ultra-Wide Fixture) has two types of connection, Mini type and Regular type that are same as OSSTEM Implant System - Abutment connection structure as below dimension table.
| TS Fixture System<br>(K121995) | Design | Nominal<br>Diameter | Diameter | Connection |
|--------------------------------|------------------------------------|---------------------|-----------------------|------------|
| TSII SA Fixture | Image: TSII SA Fixture | 3.5 | 3.5mm | Mini |
| | | 4.0 | 4.2mm | Regular |
| | | 4.5 | 4.4mm | Regular |
| | | 5.0 | 4.9mm | Regular |
| TSIII SA Fixture | Image: TSIII SA Fixture | 3.5 | 3.75mm, 3.77mm | Mini |
| | | 4.0 | 4.2mm, 4.25mm | Regular |
| | | 4.5 | 4.6mm, 4.63mm, 4.65mm | Regular |
| | | 5.0 | 5.05mm, 5.08mm, 5.1mm | Regular |
| TSIII SA Ultra-Wide<br>Fixture | Image: TSIII SA Ultra-Wide Fixture | 6.0 | 5.92mm, 5.95mm, 6.0mm | Regular |
| | | 7.0 | 6.8mm | Regular |
5. Indications for Use:
The OSSTEM Implant System - Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
- 6. Substantial Equivalence Matrix:
Proposed devices in the this submission were all predicated by 510(k); therefore, indication for use, shape, connection structure, material, surface treatment, manufacturer and etc. are
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Image /page/7/Picture/1 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The logo includes the company name in bold, along with the company's address, phone number, fax number, and website. The address is 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea. The phone number is +82 51 850-2500, the fax number is +82 51 850-4341, and the website is www.osstem.com.
the same with predicated devices except dimension of additional products and new compatibility with TS SA Fixtures – K121995.
Refer to the difference of additional products for detail as below table.
#### - Substantial Equivalence Matrix
| Part Name | ZioCera Abutment | ZioCera Abutment | Identity |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| | Proposed | Predicate | |
| 510K | - | K081786 | |
| Material | Zirconia | Zirconia | Identical |
| Design | Image: ZioCera Abutment Proposed | Image: ZioCera Abutment Predicate | Connection<br>structure is<br>different (Hex and<br>Non-Hex) but<br>Design is<br>Substantial<br>Equivalence |
| Dimension<br>Diameter (mm) | 4.5, 5.5, 6.5 | 4.5, 5.5, 6.5 | Diameter is<br>identical |
| Length of post<br>(mm) | 7 | 7 | Identical |
| Indication for<br>use | The OSSTEM Implant System -<br>Abutment is intended for use<br>with a dental implant to provide<br>support for prosthetic<br>restorations such as crowns,<br>bridges, or overdentures. | Ziocera & Convertible Systems<br>are intended for use as an aid in<br>prosthetic restoration. | Indication for use<br>of subject device<br>is slight<br>differences in<br>phrase with<br>predicate but<br>fundamental<br>Indication is same |
| Technological<br>Characteristics | Use for making general cement-<br>type prosthesis. | Use for making general cement-<br>type prosthesis. | Identical |
| SE | ZioCera Abutment has cleared with K081786, Ziocera & Convertible System. Therefore<br>ZioCera Abutment is resubmitted to add Hex type ZioCera Abutment<br>Proposed ZioCera Abutment are exactly same with predicate ZioCera abutment except<br>connection structure (diameter and Length of post are also same)<br>We state ZioCera Abutment is substantial Equivalence from predicate, ZioCera Abutment<br>(K081786) | | |
| | Proposed Device | Predicate Device | Identity |
|-----------|--------------------------|--------------------------|-----------|
| Part Name | Quick Temporary Abutment | Quick Temporary Abutment | |
| 510K | - | K121585 | |
| Material | Titanium Alloy<br>PEEK | Titanium Alloy<br>PEEK | Identical |
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Image /page/8/Picture/0 description: The image shows the logo for Osstem Implant. The logo is in orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. There is a superscript "6" next to the word "OSSTEM".
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. | Identical |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Description<br>(Intended for use) | used to make temporary<br>prosthesis | used to make temporary prosthesis | Identical |
| Dimension<br>(Diameter) | 4mm, 4.5mm | 4.5mm, 5.5mm | Diameter<br>4.0mm is<br>added |
| Connection | Internal Hex Connection | Internal Hex Connection | Identical |
| Technological<br>Characteristics | Cement retained restoration.<br>Capable of altering/removing<br>shape of plastic material.<br>Two piece (Abutment + Screw) | Cement retained restoration.<br>Capable of altering/removing<br>shape of plastic material.<br>Two piece (Abutment + Screw) | Identical |
| Indication for use | The OSSTEM Implant System<br>- Abutment is intended for use<br>with a dental implant to<br>provide support for prosthetic<br>restorations such as crowns,<br>bridges, or overdentures. | The TS Implant System is<br>indicated for use in partially or<br>fully edentulous mandibles and<br>maxillae, in support of single or<br>multiple-unit restorations<br>including; cemented retained,<br>screw retained, or overdenture<br>restorations, and final or temporary<br>abutment support for fixed<br>bridgework. It is intended for<br>delayed loading. The abutment is<br>intended for use with a dental<br>implant fixture to provide<br>support for prosthetic<br>restorations such as crowns,<br>bridges, or overdenture. | Phrase<br>highlighted<br>Is Identical |
| Design | Image: Abutment | Image: Abutment | Shape of<br>Plastic<br>section<br>(PEEK) is<br>different.<br>Connection<br>structure is<br>same |
| SE | The Quick Temporary Abutment had been cleared with K121585 but it is being<br>resubmitted to add revised shape therefore Quick Temporary Abutment and Predicate<br>devices have same function, material, Connection structure, characteristic and intended use<br>We state Quick Temporary Abutment is substantial Equivalence from predicate, Quick<br>Temporary Abutment (K121585). | | |
| Part Name | Proposed Device | Predicate Device | Identity |
|--------------|-------------------------------------------|-------------------------------------------|-----------|
| | FreeForm ST Abutment | FreeForm ST Abutment | |
| 510K | - | K120847 | |
| Material | Titanium Alloy (Ti-6Al-4V),<br>ASTM F 136 | Titanium Alloy (Ti-6Al-4V),<br>ASTM F 136 | Identical |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. | Identical |
| Description | Use for the path adjustment of | Use for the path adjustment of | Identical |
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Image /page/9/Picture/0 description: The image shows the alphanumeric string "K161689" in a clear, sans-serif font. The characters are uniformly sized and spaced, creating a balanced visual appearance. The string is presented in a straightforward manner, without any additional graphical elements or stylistic enhancements.
Image /page/9/Picture/1 description: The image contains the logo for Osstem Implant. The logo is in two lines, with the word "OSSTEM" in orange on the top line and the word "IMPLANT" in gray on the bottom line. There is a small orange circle with a white number 6 in the upper right corner of the logo.
| (Intended for use) | abutment or customization of<br>prosthetic margin. | abutment or customization of<br>prosthetic margin. | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Indication for use | The OSSTEM Implant System<br>- Abutment is intended for use<br>with a dental implant to<br>provide support for prosthetic<br>restorations such as crowns,<br>bridges, or overdentures. | The ET/SS Implant System is<br>indicated for use in partially or<br>fully edentulous mandibles and<br>maxillae, in support of single or<br>multiple-unit restorations<br>including; cemented retained,<br>screw retained, or overdenture<br>restorations, and final or<br>temporary abutment support for<br>fixed bridgework. It is intended<br>for delayed loading. The<br>abutment is intended for use<br>with a dental implant fixture<br>to provide support for<br>prosthetic restorations such as<br>crowns, bridges, or<br>overdenture. | Phrase highlighted<br>Is Identical |
| Technological<br>Characteristics | Use for making general cement-<br>type prosthesis. | Use for making general cement-<br>type prosthesis. | Identical |
| Dimension<br>(Diameter) | 5 | 4.0, 5.0, 5.5, 6.0, 7.0 | Diameter 5mm is<br>included dimension<br>range of predicate |
| Lenth of post<br>(mm) | 9, 10.5 | 9, 10.5 | Identical |
| Connection | Internal Hex Connection | Internal Hex Connection | Identical |
| Design | Image: Two abutments | Image: Three abutments with the first one highlighted with a red box | Design is<br>Substantial<br>Equivalence<br>With highlighted<br>predicate with red<br>Box |
| SE | No changes in function and intended use<br>Diameter and length of post are also included dimension range of predicate<br>We state FreeForm ST Abutment is substantial Equivalence with predicate, FreeForm ST<br>Abutment (K120847) | | |
| Part Name | Rigid Protect Cap | Rigid Protect Cap | Identity |
|-------------------------|----------------------------|----------------------------|---------------------------------------|
| | Proposed | Predicate | |
| 510K | - | K100245 | |
| Material | PC (PolyCarbonate Polymer) | PC (PolyCarbonate Polymer) | Identical |
| Design | Image: Rigid Protect Cap | Image: Rigid Protect Cap | Identical |
| Dimension<br>(Diameter) | 4.4, 5.0, 5.5, 6.6, 7.4 | 4.4, 5.0, 5.4, 6.6, 7.4 | 5.4mm diameter is<br>changed to 5.5mm |
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Image /page/10/Picture/0 description: The image shows the logo for Osstem Implant. The logo is orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. There is a superscript "6" next to the word "OSSTEM".
| Intended for<br>use | Use for the protection of the rigid<br>abutment in the oral cavity | Use for the protection of the rigid<br>abutment in the oral cavity | Identical |
|---------------------|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|-----------|
| S.E | No changes in function and intended use<br>Rigid Protect Cap is substantial Equivalence with predicate, Rigid Protect Cap | | |
| Part Name | Multi Abutment | Multi Abutment | Identity |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-----------|
| | Proposed | Predicate | |
| 510K | - | K130662 | |
| Material | Titanium Alloy (TiN coating) | Titanium Alloy (TiN coating) | Identical |
| Design | Image: Multi Abutment Proposed | Image: Multi Abutment Predicate | Identical |
| Dimension<br>(Diameter) | 4.8 | 4.8 | Identical |
| Intended for use | Using for edentulous mandible or<br>maxilla.<br>Usually use to make full denture<br>Screw Retained Restoration | Using for edentulous mandible or<br>maxilla.<br>Usually use to make full denture<br>Screw Retained Restoration | Identical |
| S.E | No changes in function and intended use<br>Therefore Multi Abutment is substantial Equivalence with predicate, Multi Abutment | | |
| Product name | Identity | | |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Transfer Abutment | - Transfer Abutment has cleared with K130662<br>- Only article numbering change.<br>- No other modifications (e.g. coating changes, design changes, addition<br>of other models, etc.) | | |
| | Stud Abutment | - Stud Abutment has cleared with K110308.<br>- Only article numbering change.<br>- No other modifications (e.g. coating changes, design changes, addition<br>of other models, etc.) | |
| | | Rigid Retraction Cap | - Rigid Retraction Cap has cleared with K100245.<br>- Only article numbering change.<br>- No other modifications (e.g. design changes, addition of other models,<br>etc.) |
| | | | Custom Healing Abutment |
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Image /page/11/Picture/1 description: The image shows the logo for Osstem Implant. The logo is orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. The logo is simple and modern.
6-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea 'el: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
| Rigid Abutment | - Rigid Abutment has cleared with K130662.<br>- Only article numbering change.<br>- No other modifications (e.g. coating changes, design changes, addition of other models, etc.) |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Temporary Abutment | - Temporary Abutment has cleared with K110308.<br>- Only article numbering change.<br>- No other modifications (e.g. coating changes, design changes, addition of other models, etc.) |
| O-ring Retainer Cap Set<br>O-ring Retainer Set<br>O-ring Set | - O-ring Retainer Cap Set, O-ring Retainer Set and O-ring Set has cleared with K140507.<br>- Only article numbering change.<br>- No other modifications (e.g. coating changes, design changes, addition of other models, etc.) |
| Abutment Screw | - The Abutment Screw has a cleared with 510(k), K110308 and K081786.<br>- Only article numbering change.<br>- No other modifications (e.g. coating changes, design changes, addition of other models, etc.) |
#### 7. Summary of nonclinical testing:
The following nonclinical testing data were provided or relied upon in support of the substantial equivalence determination.
#### Biocompatibility
As the material of construction, manufacturing process, chemical composition, and body contact are same as the predicate devices, ET Prosthetic System, OSSTEM Implant Co., Ltd., K130662; ET SS Implant System, OSSTEM Implant Co., Ltd., K120847; Ziocera & Convertible System, OSSTEM Implant Co., Ltd., K081786; TS Implant System, OSSTEM Implant Co., Ltd., K121585; GS System, OSSTEM Implant Co., Ltd., K063861; Prosthetic System, K110308; HS, HG Prosthetic System, K100245; and Hiossen Prosthetic System, K140507. Therefore, no additional testing is necessary. .
#### Sterilization Validation
For Custom Healing Abutment, it is same in material, dimension, and manufacturer with predicated Custom Healing Abutment in Hiossen Prosthetic System, K140507; and result of the sterilization validation report is leveraged that was conducted according to ISO 11137-1. ISO 11137-2 and ISO 11137-3, as well as the shelf life testing which was leveraged from K062051: tensile test (ASTM F882), seal peel test (ASTM F88/EN868-5), burst test (ASTM F1140), dye penetration (ASTM F1929), bubble test (ASTM F2096), and sterility testing (ISO 11737-2). Therefore, no additional testing is required.
Except for Custom Healing Abutment, the rest are non-sterile devices and steam sterilization validation was conducted according to ISO 17665-1 and ISO 17665-2.
#### 8. Summary of clinical testing:
No clinical studies are submitted.
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Image /page/12/Picture/1 description: The image shows the logo for Osstem Implant. The logo is comprised of the word "OSSTEM" in orange, stacked on top of the word "IMPLANT" in gray. A small orange superscript "6" is located to the right of the word "OSSTEM".
- 9. Conclusions:
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 CO., LTD. concludes that OSSTEM Implant System - Abutment is substantially equivalent to the predicate devices as described herein.
