(145 days)
The OSSTEM 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 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.
The provided document is a 510(k) summary for the Osstem Implant Co., Ltd. TS Abutment System. It describes the device and claims substantial equivalence to previously cleared predicate devices. The document does not describe a study that uses acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity, nor does it involve expert reviews or clinical trials for such metrics.
Instead, the submission focuses on demonstrating substantial equivalence through comparisons of technical characteristics and performance testing (bench testing, biocompatibility, sterilization validation, etc.) against existing predicate devices and established standards.
Therefore, most of the requested information regarding acceptance criteria for device performance (accuracy, sensitivity), sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment would not be applicable to this type of regulatory submission. This submission does not pertain to an AI/ML powered device, but rather a physical dental implant component.
However, I can extract information related to the technical comparisons that demonstrate substantial equivalence.
1. A table of acceptance criteria and the reported device performance
The document does not present explicit acceptance criteria in terms of numerical performance metrics (e.g., specific thresholds for accuracy, sensitivity). Instead, the acceptance is based on demonstrating that the subject device's characteristics and performance are "substantially equivalent" to predicate devices, often by adhering to established standards or by justifying that any differences do not raise new questions of safety or effectiveness. The reported "performance" for most components is implicitly that they function equivalently to their predicates and meet relevant mechanical and biological standards.
Here's a summary of the non-clinical performance and "acceptance criteria" through comparative analysis:
| Aspect | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical Properties (Fatigue) | The fatigue performance of the proposed device is considered to be equal to or greater than that of the reference/primary predicate device. This is often justified by: - Same design, function, connection, and platform as predicate. - Adherence to ISO 14801 standard (maintaining 11mm distance between embedding plane and hemispherical loading member). - Differences (e.g., added lengths or diameters) not creating a new worst-case scenario. | Rigid Abutment: No additional fatigue testing conducted, as the proposed device has the same design, function, connection, platform, and moment arm as the reference/predicate, and added lengths are within acceptable ranges or previously cleared for similar components.Transfer Abutment: No additional fatigue testing conducted for similar reasons, justifying that changes in connection features were evaluated and not a new worst case, and that the device has the same moment arm.Angled Abutment: No additional fatigue testing conducted, as differences in feature (guide for connecting with implant body) do not change the fundamental design or platform and the proposed device's fatigue is considered equal to or greater than the predicate.FreeForm ST Abutment: No additional fatigue testing conducted, as added dimensions are within the range of the reference device and it maintains the same moment arm.Temporary Abutment: No additional performance test needed as it's for temporary use, and the proposed gingiva height has primary predicate clearance.Multi Abutment: No additional fatigue testing conducted, as added dimensions (gingival height) are covered by primary predicates and it maintains the same moment arm.Ti Cylinder Screw: No fatigue testing considered necessary as it's a component using with cylinder, and material biocompatibility is established.Convertible Abutment: No additional performance tests as difference is sterilization process. Its mechanical performance is expected to be equivalent to predicate. |
| Biocompatibility | The device materials must have acceptable biocompatibility, typically demonstrated by using materials already cleared in predicate devices or by following ISO 10993-1. | The TS Abutment System uses the same materials (e.g., Ti-6Al-4V (ASTM F136), Titanium Gr.3 (ASTM F67), Titanium Gr.4 (ASTM F67)), manufacturer, manufacturing process, and surface treatment as primary predicate and reference devices. Therefore, no additional biocompatibility testing was conducted. |
| Sterilization Validation | The sterilization process must be validated to ensure sterility, or justified if changes from predicates do not create a new worst-case scenario. For sterile devices, shelf-life must be validated. | For those components provided sterile, the validation of the gamma irradiation process was previously conducted for the predicate device. Changes in dimensions for the subject device do not create a new worst-case scenario for sterilization, thus no additional validation was required. Shelf-life for sterile components (e.g., Transfer Abutment, Angled Abutment, Multi Abutment, Convertible Abutment, Port Abutment, Stud Abutment, Healing Abutment) is established as 8 years. For non-sterile devices made of titanium, no specific shelf-life is considered for the material itself due to its known stability. |
| Pyrogen Test | Absence of pyrogens to meet established standards (e.g., ISO 10993-11:2006 and USP<151>). | Bacterial Endotoxin Test Report on implants was referenced from K161604, indicating previous compliance. |
| MR Compatibility | Evaluation of magnetically induced displacement force and torque based on FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." | Non-clinical worst-case MRI review was performed using scientific rationale and published literature (e.g., Woods et al., 2019), addressing parameters for magnetically induced displacement force and torque for all compatible implant bodies, abutments, and fixation screws and material composition. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. This submission relies on comparisons to predicate devices and existing standards, not a new test set for performance evaluation in the clinical sense (e.g., diagnostic accuracy).
- Data Provenance: The document references previously cleared 510(k) submissions (e.g., K182091, K161689, K221684, K163634, K161604, K120847) from Osstem Implant Co., Ltd. and one from Southern Implants (Pty) Ltd. The specific country of origin for the data from these predicate clearances is not detailed in this summary, but the manufacturer of the subject device is based in the Republic of Korea. The data is retrospective, as it refers to performance data and justifications from prior clearances.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No "ground truth" as typically understood in AI/ML diagnostic performance studies was established or used for this device's submission. The evaluation is based on engineering principles, materials science, and conformity to recognized standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No "ground truth" of this nature was used. The ground truth, in a regulatory sense for this type of device, is conformity to established material specifications, manufacturing processes, and recognized performance standards (like ISO 14801 for fatigue testing).
8. The sample size for the training set
Not applicable. This is not an AI-powered device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI-powered device.
{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 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.
{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) 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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
{4}------------------------------------------------
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,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 | : 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.
{5}------------------------------------------------
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)4.04.65.0 | G/H6.0, 7.06.0, 7.06.0, 7.0 | ||
| Transfer Abutment | Description | It is used for making general cement-type prosthesis. | ||
| Material | Ti-6Al-4V (ASTM F136) | |||
| Dimension (mm) | D(Ø)4.04.65.06.07.0 | G/H1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.01.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.01.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.01.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.01.0, 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)4.04.55.06.0 | G/H2.0, 4.02.0, 4.02.0, 4.02.0, 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)5.5 | G/H1.5, 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(mm) | D(Ø) | G/H | Post | |
| Stud Abutment | Dimension(mm) | 3.7 | 1.0, 2.0, 3.0, 4.0, 5.0,6.0, 7.0 | 1.5 |
| Description | It is used for prosthetic restoration. It is used for making studtype overdenture prosthetics. | |||
| Material | Ti-6Al-4V (ASTM F136) | |||
| Dimension(mm) | D(Ø)3.5 | G/H1.0, 2.0, 3.0, 4.0, 5.0,6.0 | Post2.5, 3.35 | |
| Description | It is used to make a natural soft tissue shape before setting upprosthetics and removing cover screw after osseointegration. | |||
| Material | Titanium Gr.4 (ASTM F67) | |||
| Healing Abutment | Dimension(mm) | D(Ø)4.34.85.36.37.38.39.3 | L2.0, 6.0, 8.06.0, 8.0, 10.06.0, 8.0, 10.0, 11.0, 12.06.0, 8.06.0, 8.06.0, 8.05.0, 6.0, 8.0 |
The specifications of the proposed device are as follow;
{6}------------------------------------------------
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: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com.
{7}------------------------------------------------
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: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com.
{8}------------------------------------------------
Page 5 of 31
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 +82 51 850 2500, the fax number is +82 51 861 4693, 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
- 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 isintended for use with a dental implant toprovide support for prostheticrestorations such as crowns, bridges, oroverdentures. | The OSSTEM Implant System -Abutment is intended for use with adental implant to provide support forprosthetic restorations such as crowns,bridges, or overdentures. | Osstem Abutment System is intended foruse with a dental implant to providesupport for prosthetic restorations suchas crowns, bridges, or overdentures. | Same | |
| Principle ofOperation | Using making for general cement-typeprosthesis. | Using making for general cement-typeprosthesis. | Using making for general cement-typeprosthesis. | 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, 3.0,4.0, 5.0 | 4.0, 5.5,7.0 | |||
| 4.6 | 1.0, 2.0, 3.0,4.0, 5.0 | 4.0, 5.5,7.0 | |||
| 5.0 | 1.0, 2.0, 3.0,4.0, 5.0 | 4.0, 5.5,7.0 | |||
| 6.0 | 1.0, 2.0, 3.0,4.0, 5.0 | 4.0, 5.5,7.0 | |||
| 7.0 | 1.0, 2.0, 3.0,4.0, 5.0 | 5.5 | |||
| D(Ø) | G/H | Post | |||
| 4.0 | 1.0, 2.0, 3.0,4.0, 5.0, 6.0,7.0 | 5.5, 7.0 | Different | ||
| 4.6 | 1.0, 2.0, 3.0,4.0, 5.0, 6.0,7.0 | 5.5, 7.0 | |||
| 5.0 | 1.0, 2.0, 3.0,4.0, 5.0, 6.0,7.0 | 4.0, 5.5,7.0 | |||
| 6.0 | 1.0, 2.0, 3.0,4.0, 5.0, 6.0,7.0 | 4.0, 5.5,7.0 | |||
| 7.0 | 1.0, 2.0, 3.0,4.0, 5.0, 6.0,7.0 | 4.0, 5.5 | |||
| Material | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) | Same | ||
| SurfaceTreatment | N/A | N/A | Same | ||
| S.E. | SimilaritiesProposed Rigid Abutment has same design, function and indication for use; and is made with same material with same manufacturing process by same manufacturer compared to that of the reference device Rigid Abutment, K161689.DifferencesThe added lengths differ from the dimension range of the reference device because new length combination is added to the same diameter range as primary predicate. However, proposed device has same design, function, connection and platform as reference device. Also, primary predicate for the increased gingival height of 6mm and 7mm is already cleared in Transfer Abutment, K182091.In addition, since proposed device is straight type and the distance between the embedding plane and the centre of the hemispherical loading member always is 11mm according to the ISO 14801, it has same moment arm.As a result, the fatigue of the proposed device is considered to be equal to or greater than that of the reference device. Therefore, we don't conduct additional fatigue testing. |
{9}------------------------------------------------
Page 6 of 31
OSSTEM® IMPLANT
OSSTEM Implant Co., Ltd.
OSSTEM Implant Co., Ltd.
66-16, Bansong-o 513beon-gil, Haunda-gu, Busan, Republic of Korea
Tel: +82 51 850 250 Fax: +82 51 861 4693 www.osstem.com
{10}------------------------------------------------
OSSTEM
IMPLANT
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
: Proposed Rigid Abutment and the reference device have common in design, for use, material, manufacturing process, manufacturer, etc.; therefore, the proposed device is substantially equivalent to the reference device.
Page 7 of 31
{11}------------------------------------------------
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
2) Transfer Abutment
| Subject Device | Primary Predicate | Remark | |||||
|---|---|---|---|---|---|---|---|
| Device Name | Transfer Abutment | Transfer Abutment | Different | ||||
| 510(k) Number | - | K182091 | - | ||||
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same | ||||
| Design | Image: Subject Device Design | Image: Primary Predicate Design | Different | ||||
| 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. | Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. | Same | ||||
| Principle of Operation | Using making for general cement-type prosthesis. | Using making for general cement-type prosthesis. | Same | ||||
| Dimension (mm) | D(Ø) | G/H | Post | D(Ø) | G/H | Post | Different |
| 4.0 | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 | 4.0 , 5.5, 7.0 | 4.0 | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 | 5.5, 7.0 | ||
| 4.6 | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 | 4.0, 5.5, 7.0 | 4.6 | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 | 5.5, 7.0 | ||
| 5.0 | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 | 4.0, 5.5, 7.0 | 5.0 | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 | 4.0, 5.5, 7.0 | ||
| 6.0 | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 | 4.0, 5.5, 7.0 | 6.0 | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 | 4.0, 5.5, 7.0 | ||
| 7.0 | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 | 4.0 , 5.5, 7.0 | 7.0 | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 | 4.0, 5.5 | ||
| Material | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) | Same | ||||
| Feature | Image: Subject Device Feature | Image: Primary Predicate Feature | Different | ||||
| Surface Treatment | N/A | N/A | Same | ||||
| S.E. | SimilaritiesProposed Transfer Abutment has same design, function and indication for use; and is made |
{12}------------------------------------------------
Image /page/12/Picture/2 description: The image contains the logo for Osstem Implant. The logo is in orange and consists of the word "OSSTEM" in a bold, sans-serif font, with the superscript symbol for a registered trademark. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, less bold font. The logo is simple and modern, and the orange color is eye-catching.
OSSTEM Implant Co., Ltd.
66-16, Bansong-o 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com.
| with same material with same manufacturing process by same manufacturer compared to thatof the primary predicate Transfer Abutment, K182091. |
|---|
| DifferencesThe added lengths differ from the dimension range of the primary predicate because newlength combination is added to the same diameter range as primary predicate. Also, proposeddevice differs in feature from the primary predicate because it has a guide to supportconnecting with the implant body. However, this change in connection features wasevaluated and determined that is not a new worst case for bench testing. |
| In addition, since proposed device is straight type and the distance between the embeddingplane and the centre of the hemispherical loading member always is 11mm according to theISO 14801, it has same moment arm. |
| As a result, the fatigue of the proposed device is considered to be equal to or greater than thatof the primary predicate. Therefore, we don't conduct additional fatigue testing. |
| .: Proposed Transfer Abutment and the primary predicate have common in design, function,indication for use, material, manufacturing process, manufacturer, etc.; therefore, theproposed device is substantially equivalent to the primary predicate. |
3) Angled Abutment
| Subject Device | Primary Predicate | Remark | |
|---|---|---|---|
| Device Name | Angled Abutment | Angled Abutment | Same |
| 510(k) Number | - | K182091 | - |
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same |
| Design | Image: Angled Abutment | Image: Angled Abutment | Different |
| Indication forUse | The OSSTEM Abutment system isintended for use with a dental implantto provide support for prostheticrestorations such as crowns, bridges, oroverdentures. | Osstem Abutment System is intendedfor use with a dental implant to providesupport for prosthetic restorations suchas crowns, bridges, or overdentures. | Same |
| Principle ofOperation | Using making general cement-typeprosthesis when a prosthetic's pathadjustment is necessary. | Using making general cement-typeprosthesis when a prosthetic's pathadjustment is necessary. | Same |
{13}------------------------------------------------
Image /page/13/Picture/2 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, sans-serif font. There is a small circle in the upper right corner of the logo.
OSSTEM Implant Co., Ltd.
OSSTEM Implant Co., Ltd.
66-16, Bansong-n 513beon-gil, Haeunda-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com.
| D(Ø) | G/H | Post | D(Ø) | G/H | Post | ||
|---|---|---|---|---|---|---|---|
| Dimension(mm) | 4.0 | 2.0, 4.0 | 8.0 | 4.0 | 2.0, 4.0 | 8.0 | Same |
| 4.5 | 2.0, 4.0 | 8.0 | 4.5 | 2.0, 4.0 | 8.0 | ||
| 5.0 | 2.0, 4.0 | 8.0 | 5.0 | 2.0, 4.0 | 8.0 | ||
| 6.0 | 2.0, 4.0 | 8.0 | 6.0 | 2.0, 4.0 | 8.0 | ||
| Angled( °) | 17 | 17 | Same | ||||
| Material | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) | Same | ||||
| Feature | Image: Feature 1 | Image: Feature 2 | Different | ||||
| SurfaceTreatment | N/A | N/A | Same | ||||
| S.E. | SimilaritiesProposed Angled Abutment has same design, function and indication for use; and is madewith same material with same manufacturing process by same manufacturer compared to thatof the primary predicate Angled Abutment, K182091.DifferencesThe proposed device differs in feature from the primary predicate because it has a guide tosupport connecting with the implant body. However, proposed device has same design,function, connection and platform as primary predicate.As a result, the fatigue of the proposed device is considered to be equal to or greater than thatof the primary predicate. Therefore, we don't conduct additional fatigue testing.∴ Proposed Angled Abutment and the primary predicate have common in design, function,indication for use, material, manufacturing process, manufacturer, etc.; therefore, theproposed device is substantially equivalent to the primary predicate. |
4) FreeForm ST Abutment
| Subject Device | Reference Device | Remark | |
|---|---|---|---|
| Device Name | FreeForm ST Abutment | FreeForm ST Abutment | Same |
| 510(k) Number | - | K161689 | - |
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same |
| Design | Image: Subject Device | Image: Reference Device | Same |
{14}------------------------------------------------
Image /page/14/Picture/2 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a registered trademark symbol next to it. Below the word "OSSTEM" is the word "IMPLANT" written in a smaller, darker font.
OSSTEM Implant Co., Ltd.
OSSTEM Implant Co., Ltd.
66-16, Bansong-n 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com.
| 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. | 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. | Same | ||||
|---|---|---|---|---|---|---|---|
| Principle of Operation | Use for making general cement-type prosthesis. | Use for making general cement-type prosthesis. | Same | ||||
| Dimension (mm) | D(Ø) | G/H | Post | D(Ø) | G/H | Post | |
| 5.5 | 1.5, 3.0 | 8.0 | 4.05.06.07.0 | 1.5, 3.01.5, 3.01.5, 3.01.5, 3.0 | 9.0, 10.59.0, 10.59.0, 10.59.0, 10.5 | Different | |
| Material | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) | Same | ||||
| Surface Treatment | N/A | N/A | Same | ||||
| S.E. | SimilaritiesProposed FreeForm ST Abutment has same design, function and indication for use; and is made with same material with same manufacturing process by same manufacturer compared to that of the reference device FreeForm ST Abutment, K161689.DifferencesThe added diameter Ø 5.5 and length 8mm differs from reference device; but it is included in the dimension range of the reference device. In addition, since proposed device is straight type and the distance between the embedding plane and the centre of the hemispherical loading member always is 11mm according to the ISO 14801, it has same moment arm.As a result, the fatigue of the proposed device is considered to be equal to or greater than that of the reference device. Therefore, we don't conduct additional fatigue testing.Proposed FreeForm ST Abutment and the reference device have common in design, function, indication for use, material, manufacturing process, manufacturer, etc.; therefore, the proposed device is substantially equivalent to the reference device. |
{15}------------------------------------------------
OSSTEM® IMPLANT
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
5) Temporary Abutment
| Subject Device | Reference Device | Primary Predicate | Primary Predicate | Remark | |
|---|---|---|---|---|---|
| Device Name | Temporary Abutment | Temporary Abutment | Temporary Abutment | Transfer Abutment | Same |
| 510(k) Number | - | K221684 | K182091 | K182091 | - |
| Manufacturer | Osstem Implant Co., Ltd | 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 | Image: Primary Predicate Design | Same |
| Indication for Use | The OSSTEM Abutmentsystem is intended for usewith a dental implant toprovide support for prostheticrestorations such as crowns,bridges, or overdentures. | The OSSTEM AbutmentSystem is intended for usewith a dental implant toprovide support for prostheticrestorations such as crowns,bridges, or overdentures. | Osstem Abutment System isintended for use with a dentalimplant to provide support forprosthetic restorations such ascrowns, bridges, oroverdentures. | Osstem Abutment System isintended for use with a dentalimplant to provide support forprosthetic restorations such ascrowns, bridges, oroverdentures. | Same |
| Principle ofOperation | Using making temporaryprosthesis to maintainaesthetic appearance untilfinal prosthesis is made. | Using making temporaryprosthesis to maintainaesthetic appearance untilfinal prosthesis is made. | Using making temporaryprosthesis to maintainaesthetic appearance untilfinal prosthesis is made. | Using making for generalcement-type prosthesis. | Same |
| Dimension (mm) | D(Ø)G/HPost | D(Ø)G/HPost | D(Ø)G/HPost | D(Ø)G/HPost | |
| 4.07.010.0 | 4.01.0, 3.010 | 4.01.0, 3.010 | 4.01.0, 2.0,3.0, 4.0,5.0, 6.0,7.05.5, 7.0 | Different | |
| 4.57.010.0 | 4.51.0, 3.010 | 4.51.0, 3.010 | 4.61.0, 2.0,3.0, 4.0,5.0, 6.0,7.05.5, 7.0 | ||
| 5.01.0, 2.0,3.0, 4.0,5.0, 6.0,7.04.0, 5.5,7.0 | |||||
| 6.01.0, 2.0,3.0, 4.0,5.0, 6.0,7.04.0, 5.5,7.0 | |||||
| 7.01.0, 2.0,3.0, 4.0,5.0, 6.0,7.04.0, 5.5 | |||||
| Material | Titanium Gr.3 (ASTM F67) | Titanium Gr.3 (ASTM F67) | Titanium Gr.3 (ASTM F67) | Titanium Alloy (ASTM F136) | Same |
| SurfaceTreatment | N/A | N/A | N/A | N/A | Same |
| S.E. | SimilaritiesProposed Temporary Abutment has same design, function and indication for use; and is made with same material with same manufacturingprocess by same manufacturer compared to that of the reference device and primary predicate Temporary Abutment, K221684 and K182091.DifferencesTemporary Abutment is used to make temporary prosthesis for esthetic purpose for healing placement of implant, so the length ofgingiva height does not affect the any performance.Also, the proposed gingiva height 7mm differs from predicate and reference device; but the proposed diameter is same as referencedevice, and primary predicate for the increased gingival height of 7mm is already cleared in Transfer Abutment, K182091. |
{16}------------------------------------------------
Page 13 of 31
OSSTEM®
OSSTEM Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haundae-gu, Busan, Republic of Korea
Tel: +82 51 850 250 Fax: +82 51 861 4693 www.osstem.com
{17}------------------------------------------------
OSSTEM® IMPLANT
OSSTEM Implant Co., Ltd.
OSSTEM Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com.
| Proposed device is used for temporary use and also has primary predicate for the increased gingival height. Therefore, we don't conduct additional performance test. |
|---|
| : Proposed Temporary Abutment and the primary predicate have common in design, function, indication for use, material, manufacturing process, manufacturer, etc.; therefore, the proposed device is substantially equivalent to the primary predicate. |
6) Multi Abutment
| Subject Device | Reference Device | Primary Predicate | Remark | |
|---|---|---|---|---|
| Device Name | Multi Abutment | Multi 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: Multi Abutment | Image: Multi Abutment | Image: Transfer Abutment | Same |
| Indication for Use | The OSSTEM Abutment system isintended for use with a dental implant toprovide support for prostheticrestorations such as crowns, bridges, oroverdentures. | The OSSTEM Implant System -Abutment is intended for use with adental implant to provide support forprosthetic restorations such as crowns,bridges, or overdentures. | Osstem Abutment System is intended foruse with a dental implant to providesupport for prosthetic restorations suchas crowns, bridges, or overdentures. | Same |
| Principle ofOperation | Using for edentulous mandible ormaxilla. Usually use to make full denturescrew-retained restoration. | Using for edentulous mandible ormaxilla. Usually use to make full denturescrew-retained restoration. | Using making for general cement-typeprosthesis. | Same |
Page 14 of 31
{18}------------------------------------------------
Page 15 of 31
OSSTEM® IMPLANT
OSSTEM Implant Co., Ltd.
66-16, Bansong-o 513beon-gil, Haunda-gu, Busan, Republic of Korea
Tel: +82 51 850 250 Fax: +82 51 861 4693 www.osstem.com
| D(Ø) | G/H | Post | |||||
|---|---|---|---|---|---|---|---|
| 4.0 | 1.0, 2.0, 3.0,4.0, 5.0, 6.0,7.0 | 5.5, 7.0 | |||||
| 4.6 | 1.0, 2.0, 3.0,4.0, 5.0, 6.0,7.0 | 5.5, 7.0 | |||||
| Dimension (mm) | D(Ø)4.8 | G/H6.0, 7.0 | Post2.3 | ||||
| D(Ø)4.8 | G/H1.0, 2.0, 3.0,4.0, 5.0 | Post2.3 | |||||
| 5.0 | 1.0, 2.0, 3.0,4.0, 5.0, 6.0,7.0 | 4.0, 5.5,7.0 | Different | ||||
| 6.0 | 1.0, 2.0, 3.0,4.0, 5.0, 6.0,7.0 | 4.0, 5.5,7.0 | |||||
| 7.0 | 1.0, 2.0, 3.0,4.0, 5.0, 6.0,7.0 | 4.0, 5.5 | |||||
| Material | Ti-6Al-4V (ASTM F136) | Titanium Alloy (ASTM F136) | Same | ||||
| SurfaceTreatment | N/A | N/A | Same | ||||
| S.E. | SimilaritiesProposed Multi Abutment has same design, function, dimension range and indication for use; and is made with same material with same manufacturing process by same manufacturer compared to that of the reference device Multi Abutment, K161689.DifferencesThe proposed gingiva height 6mm and 7mm differ from reference device; but the proposed diameter is same as reference device, and primary predicate for the increased gingival height of 6mm and 7mm is already cleared in Transfer Abutment, K182091. In addition, since proposed device is straight type and the distance between the embedding plane and the centre of the hemispherical loading member always is 11mm according to the ISO 14801, it has same moment arm.As a result, the fatigue of the proposed device is considered to be equal to or greater than that of the reference device. Therefore, we don't conduct additional fatigue testing.∴ Proposed Multi Abutment and the reference device have common in design, function, indication for use, material, manufacturing process, manufacturer, etc .; therefore, the proposed device is substantially equivalent to the reference device. |
{19}------------------------------------------------
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
7) Ti Cylinder Screw
| Subject Device | Primary Predicate | Remark | |
|---|---|---|---|
| Device Name | Ti Cylinder Screw | EbonyGold Cylinder Screw | Same |
| 510(k) Number | - | K182091 | - |
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same |
| Design | Image: Ti Cylinder Screw | Image: EbonyGold Cylinder Screw | Different |
| Indication forUse | The OSSTEM Abutment system isintended for use with a dental implantto provide support for prostheticrestorations such as crowns, bridges,or overdentures. | Osstem Abutment System is intendedfor use with a dental implant toprovide support for prostheticrestorations such as crowns, bridges,or overdentures. | Same |
| Principle ofOperation | Using to connect a cylinder to theabutment. | Using to connect a cylinder to theabutment. | Same |
| Dimension (mm) | D(Ø)2.22.5 | L4.354.9 | D(Ø)2.22.5 |
| L4.354.9 | Same | ||
| Material | Ti-6Al-4V (ASTM F136) | Ti-6Al-4V (ASTM F136) | Same |
| Surfacetreatment | N/A | WC Coating | Different |
| S.E. | SimilaritiesProposed Ti Cylinder Screw has same design, function, dimension range and indication foruse; and is made with same material with same manufacturing process by samemanufacturer compared to that of the primary predicate EbonyGold Cylinder Screw,K182091.DifferencesThe only difference is surface treatment. The primary predicate has WC coating surface, butthe proposed device has no surface treatment. However, since the proposed device is acomponent using with cylinder, we don't consider fatigue testing. In addition, the proposeddevice has a difference in surface coating from the primary predicate, but there is nodifference in biocompatibility because it has the same raw material as the Abutments madeof titanium alloy already cleared in K182091.Proposed Ti Cylinder Screw and the primary predicate have common in design, function,indication for use, material, manufacturing process, manufacturer, etc.; therefore, theproposed device is substantially equivalent to the primary predicate. |
1.2 Sterile Device
- Transfer Abutment
{20}------------------------------------------------
Image /page/20/Picture/2 description: The image shows the logo for Osstem Implant. The logo is in 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: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com.
| Subject Device | Primary Predicate | Remark | ||||
|---|---|---|---|---|---|---|
| Device Name | Transfer Abutment | Transfer Abutment | Different | |||
| 510(k) Number | - | K182091 | - | |||
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same | |||
| Design | Image: Subject Device Design | Image: Primary Predicate Design | Different | |||
| Indication forUse | The OSSTEM Abutment system isintended for use with a dental implantto provide support for prostheticrestorations such as crowns, bridges, oroverdentures. | Osstem Abutment System is intendedfor use with a dental implant to providesupport for prosthetic restorations suchas crowns, bridges, or overdentures. | Same | |||
| Principle ofOperation | Using making for general cement-typeprosthesis. | Using making for general cement-typeprosthesis. | Same | |||
| D(Ø) | G/H | Post | D(Ø) | G/H | Post | |
| Dimension(mm) | 4.0 | 1.0, 2.0, 3.0,4.0, 5.0, 6.0,7.0 | 4.0, 5.5,7.0 | 4.0 | 1.0, 2.0, 3.0,4.0, 5.0, 6.0,7.0 | 5.5, 7.0 |
| 4.6 | 1.0, 2.0, 3.0,4.0, 5.0, 6.0,7.0 | 4.0, 5.5,7.0 | 4.6 | 1.0, 2.0, 3.0,4.0, 5.0, 6.0,7.0 | 5.5, 7.0 | |
| 5.0 | 1.0, 2.0, 3.0,4.0, 5.0, 6.0,7.0 | 4.0, 5.5,7.0 | 5.0 | 1.0, 2.0, 3.0,4.0, 5.0, 6.0,7.0 | 4.0, 5.5,7.0 | |
| 6.0 | 1.0, 2.0, 3.0,4.0, 5.0, 6.0,7.0 | 4.0, 5.5,7.0 | 6.0 | 1.0, 2.0, 3.0,4.0, 5.0, 6.0,7.0 | 4.0, 5.5,7.0 | |
| 7.0 | 1.0, 2.0, 3.0,4.0, 5.0, 6.0,7.0 | 4.0, 5.5,7.0 | 7.0 | 1.0, 2.0, 3.0,4.0, 5.0, 6.0,7.0 | 4.0, 5.5 | |
| Material | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) | Same | |||
| Feature | Image: Subject Device Feature | Image: Primary Predicate Feature | Different | |||
| Sterilization | Provided sterile(Radiation Sterile for IdentifierTSTAWH and TSTATH) | Sterile by end users | Different | |||
| Shelf-life | 8 years | N/A | Different | |||
| SurfaceTreatment | N/A | N/A | Same |
{21}------------------------------------------------
Image /page/21/Picture/1 description: The image shows the alphanumeric string "K233194" in a clear, sans-serif font. The characters are uniformly sized and spaced, making the string easily readable. The black text stands out against the white background, providing high contrast.
0
OSSTEM Implant Co., Ltd.
66-16, Bansong-n 513beon-gil, Haeunda-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com.
| SimilaritiesProposed Transfer Abutment has same design, function and indication for use; and is madewith same material with same manufacturing process by same manufacturer compared to thatof the primary predicate Transfer Abutment, K182091. | |
|---|---|
| DifferencesThe added lengths differ from the dimension range of the primary predicate because newlength combination is added to the same diameter range as primary predicate. Also, proposeddevice differs in feature from the primary predicate because it has a guide to supportconnecting with the implant body. However, proposed device has same design, function,connection and platform as primary predicate. | |
| S.E. | In addition, since proposed device is straight type and the distance between the embeddingplane and the centre of the hemispherical loading member always is 11mm according to theISO 14801, it has same moment arm. |
| As a result, the fatigue of the proposed device is considered to be equal to or greater than thatof the primary predicate. Therefore, we don't conduct additional fatigue testing. | |
| Proposed device, identifier TSTAWH and TSTATH, differs in sterilization process.The proposed device is sterilized compared to the primary predicate; but it has same rawmaterial, design, manufacturing process, etc. as that of the primary predicate. | |
| ∴ Proposed Transfer Abutment and the primary predicate have common in design, function,indication for use, material, manufacturing process, manufacturer, etc., except sterilizationprocess: therefore, the proposed device is substantially equivalent to the primary predicate. |
2) Angled Abutment
| Subject Device | Primary Predicate | Remark | |
|---|---|---|---|
| Device Name | Angled Abutment | Angled Abutment | Same |
| 510(k) Number | - | K182091 | - |
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same |
| Design | Image: Angled Abutment | Image: Angled Abutment | Different |
| Indication forUse | The OSSTEM Abutment system isintended for use with a dental implantto provide support for prostheticrestorations such as crowns, bridges, or | Osstem Abutment System is intendedfor use with a dental implant to providesupport for prosthetic restorations suchas crowns, bridges, or overdentures. | Same |
{22}------------------------------------------------
Image /page/22/Picture/1 description: The image shows the alphanumeric string "K233194" in a clear, sans-serif font. The characters are uniformly sized and spaced, creating a balanced and easily readable sequence. The text is presented in black against a white background, providing high contrast and enhancing visibility.
OSSTEM® IMPLANT
OSSTEM Implant Co., Ltd.
66-16, Bansong-n 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com.
| overdentures. | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Principle ofOperation | Using making general cement-typeprosthesis when a prosthetic's pathadjustment is necessary. | Using making general cement-typeprosthesis when a prosthetic's pathadjustment is necessary. | Same | ||||||
| D(Ø) | G/H | Post | D(Ø) | G/H | Post | ||||
| Dimension(mm) | 4.0 | 2.0, 4.0 | 8.0 | 4.0 | 2.0, 4.0 | 8.0 | Same | ||
| 4.5 | 2.0, 4.0 | 8.0 | 4.5 | 2.0, 4.0 | 8.0 | ||||
| 5.0 | 2.0, 4.0 | 8.0 | 5.0 | 2.0, 4.0 | 8.0 | ||||
| 6.0 | 2.0, 4.0 | 8.0 | 6.0 | 2.0, 4.0 | 8.0 | ||||
| Angled( °) | 17 | 17 | Same | ||||||
| Material | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) | Same | ||||||
| Feature | Image: abutment feature | Image: abutment feature | Different | ||||||
| Sterilization | Provided sterile(Radiation Sterile for IdentifierTSAAWH and TSAATH) | Sterile by end users | Different | ||||||
| Shelf-life | 8 years | N/A | Different | ||||||
| SurfaceTreatment | N/A | N/A | Same | ||||||
| S.E. | SimilaritiesProposed Angled Abutment has same design, function and indication for use; and is madewith same material with same manufacturing process by same manufacturer compared to thatof the primary predicate Angled Abutment, K182091.DifferencesThe only difference is sterilization process. The proposed device is sterilized compared to theprimary predicate; but it has same raw material, design, manufacturing process, etc. as that ofthe primary predicate.∴ Proposed Angled Abutment and the primary predicate have common in design, function,indication for use, material, manufacturing process, manufacturer, etc., except sterilizationprocess; therefore, the proposed device is substantially equivalent to the primary predicate. |
{23}------------------------------------------------
Image /page/23/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a registered trademark symbol next to it. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, gray font.
OSSTEM Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haundae-gu, Busan, Republic of Korea
Tel: +82 51 850 250 Fax: +82 51 861 4693 www.osstem.com
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
| 3) Multi Abutment | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Subject Device | Reference Device | Primary Predicate | Remark | |||||||||||||||||||||||||
| Device Name | Multi Abutment | Multi 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: Multi Abutment | Image: Multi Abutment | Image: Transfer Abutment | Same | ||||||||||||||||||||||||
| Indication for Use | The OSSTEM Abutment system isintended for use with a dental implant toprovide support for prostheticrestorations such as crowns, bridges, oroverdentures. | The OSSTEM Implant System -Abutment is intended for use with adental implant to provide support forprosthetic restorations such as crowns,bridges, or overdentures. | Osstem Abutment System is intended foruse with a dental implant to providesupport for prosthetic restorations suchas crowns, bridges, or overdentures. | Same | ||||||||||||||||||||||||
| Principle ofOperation | Using for edentulous mandible ormaxilla. Usually use to make full denturescrew-retained restoration. | Using for edentulous mandible ormaxilla. Usually use to make full denturescrew-retained restoration. | Using making for general cement-typeprosthesis. | Same | ||||||||||||||||||||||||
| 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 | D(Ø) G/H Post 4.8 1.0, 2.0, 3.0,4.0, 5.0 2.3 | D(Ø) G/H Post 4.0 1.0, 2.0, 3.0,4.0, 5.0, 6.0,7.0 5.5, 7.0 4.6 1.0, 2.0, 3.0,4.0, 5.0, 6.0,7.0 5.5, 7.0 5.0 1.0, 2.0, 3.0,4.0, 5.0, 6.0,7.0 4.0, 5.5,7.0 | Different |
Page 20 of 31
{24}------------------------------------------------
Page 21 of 31
Image /page/24/Picture/2 description: The image contains the logo for "OSSTEM IMPLANT". The word "OSSTEM" is in orange and has a registered trademark symbol next to it. The word "IMPLANT" is in a smaller, gray font and is located below the word "OSSTEM".
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
| 6.01.0, 2.0, 3.0,4.0, 5.0, 6.0,7.0 | 4.0, 5.5,7.0 | |||
|---|---|---|---|---|
| 7.01.0, 2.0, 3.0,4.0, 5.0, 6.0,7.0 | 4.0, 5.5 | |||
| Material | Ti-6Al-4V (ASTM F136) | Ti-6Al-4V (ASTM F136) | Titanium Alloy (ASTM F136) | Same |
| Sterilization | Provided sterile(Radiation Sterile for IdentifierTSMA****SP) | Sterile by end users | Sterile by end users | Different |
| Shelf-life | 8 years | N/A | N/A | Different |
| Surface Treatment | N/A | N/A | N/A | Same |
| S.E. | SimilaritiesProposed Multi Abutment has same design, function, dimension range and indication for use; and is made with same material with samemanufacturing process by same manufacturer compared to that of the reference device Multi Abutment, K221684 and K182091.DifferencesThe proposed gingiva height 6mm and 7mm differ from reference device; but the proposed diameter is same as reference device, and primarypredicate for the increased gingival height of 6mm and 7mm is already cleared in Transfer Abutment, K182091.In addition, since proposed device is straight type and the distance between the embedding plane and the centre of the hemispherical loadingmember always is 11mm according to the ISO 14801, it has same moment arm.As a result, the fatigue of the proposed device is considered to be equal to or greater than that of the reference device. Therefore, we don'tconduct additional fatigue testing.Proposed device, identifier TSMA****SP, differs in sterilization process. The proposed device is sterilized compared to the reference device;but it has same raw material, design, manufacturing process, etc. as that of the reference device..: Proposed Multi Abutment and the reference device have common in design, function, indication for use, material, manufacturing process,manufacturer, etc. except sterilization process; therefore, the proposed device is substantially equivalent to the reference device. |
{25}------------------------------------------------
Image /page/25/Picture/1 description: The image contains the logo for Osstem Implant. The logo is orange and has the word "OSSTEM" in all caps. Below the word "OSSTEM" is the word "IMPLANT" in smaller letters.
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
4) Multi Angled Abutment
| Subject Device | Reference Device | Primary Predicate | Remark | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Device Name | Multi Angled Abutment | Multi Angled Abutment | Multi Angled Abutment | Same | ||||||||||||||||||
| 510(k) Number | - | K221684 | K182091 | - | ||||||||||||||||||
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same | ||||||||||||||||||
| Design | Image: Multi Angled Abutment | Image: Multi Angled Abutment | Image: Multi Angled Abutment | Same | ||||||||||||||||||
| Indication for Use | The OSSTEM Abutment system isintended for use with a dental implant toprovide support for prostheticrestorations such as crowns, bridges, oroverdentures. | The OSSTEM Abutment System isintended for use with a dental implant toprovide support for prostheticrestorations such as crowns, bridges, oroverdentures. | Osstem Abutment System is intendedfor use with a dental implant to providesupport for prosthetic restorations suchas crowns, bridges, or overdentures. | Same | ||||||||||||||||||
| Principle ofOperation | Using making screw-retained typeprosthesis in multiple cases by usingwith Esthetic-low cylinder when pathadjustment is necessary. | Using making screw-retained typeprosthesis in multiple cases by usingwith Esthetic-low cylinder when pathadjustment is necessary. | Using making screw-retained typeprosthesis in multiple cases by usingwith Esthetic-low cylinder when pathadjustment is necessary. | Same | ||||||||||||||||||
| Dimension (mm) | D(Ø) G/H Post 4.9 2.5, 3.0, 3.5,4.0, 5.0 2.3 | D(Ø) G/H Post 4.9 5.0 2.3 | D(Ø) G/H Post 4.9 2.5,3.0,3.5,4.0,5.0 2.3 | Same | ||||||||||||||||||
| Angled( °) | 17, 30 | 17 | 17, 30 | Same | ||||||||||||||||||
| Material | Ti-6Al-4V (ASTM F136) | Ti-6Al-4V (ASTM F136) | Ti-6Al-4V (ASTM F136) | Same |
{26}------------------------------------------------
Page 23 of 31
Image /page/26/Picture/2 description: The image contains the logo for "OSSTEM IMPLANT". The word "OSSTEM" is in a bold, sans-serif font and is colored orange. The word "IMPLANT" is in a smaller, sans-serif font and is located below the word "OSSTEM". The logo is simple and clean, and it is likely used to represent a company that manufactures or sells dental implants.
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
| Sterilization | Provided sterile(Radiation Sterile) | Sterile by end users | Sterile by end users | Different |
|---|---|---|---|---|
| Shelf-life | 8 years | N/A | N/A | Different |
| SurfaceTreatment | N/A | N/A | N/A | Same |
| S.E. | SimilaritiesProposed Multi Angled Abutment has same design, function, dimension range and indication for use; and is made with same material with same manufacturing process by same manufacturer compared to that of the primary predicate Multi Angled Abutment, K221684 and K182091.DifferencesThe only difference is sterilization process. The proposed device is sterilized compared to the primary predicate; but it has same raw material, design, manufacturing process, etc. as that of the primary predicate..: Proposed Multi Angled Abutment and the primary predicate are exactly same except sterilization process; therefore, the proposed device is substantially equivalent to the primary predicate. |
{27}------------------------------------------------
Image /page/27/Picture/2 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, sans-serif font. The logo is simple and modern.
OSSTEM Implant Co., Ltd.
66-16, Bansong-o 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com.
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
5) Convertible Abutment
| Subject Device | Reference Device | Remark | ||||||
|---|---|---|---|---|---|---|---|---|
| Device Name | Convertible Abutment | Convertible Abutment | Same | |||||
| 510(k) Number | - | K120847 | - | |||||
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same | |||||
| Design | Image: Convertible Abutment | Image: Convertible Abutment | Same | |||||
| Indication forUse | The OSSTEM Abutment system isintended for use with a dental implantto provide support for prostheticrestorations such as crowns, bridges,or overdentures. | The ET/SS Implant System isindicated for use in partially or fullyedentulous mandibles and maxillae, insupport of single or multiple-unitrestorations including; cementedretained, screw retained, oroverdenture restorations, and final ortemporary abutment support for fixedbridgework. It is intended for delayedloading. The abutment is intended foruse with a dental implant fixture toprovide support for prostheticrestorations such as crowns, bridges,or overdenture. | Same | |||||
| Principle ofOperation | Use for cereating bridge caseprosthesis with dislocated path. | Use for cereating bridge caseprosthesis with dislocated path. | Same | |||||
| D(Ø) | G/H | Post | D(Ø) | G/H | Post | |||
| 4.0 | 1.0, 2.0, 3.0,4.0 | 1.0 | 4.0 | 1.0, 2.0, 3.0,4.0 | 1.0 | |||
| Dimension (mm) | 4.8 | 1.0, 2.0, 3.0,4.0, 5.0 | 1.2 | 4.8 | 1.0, 2.0, 3.0,4.0, 5.0 | 1.2 | Same | |
| 6.0 | 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 | |||
| Material | Ti-6Al-4V (ASTM F136) | Ti-6Al-4V (ASTM F136) | Same | |||||
| Sterilization | Provided sterile(Radiation Sterile) | Sterile by end users | Different | |||||
| Shelf-life | 8 years | N/A | Different | |||||
| SurfaceTreatment | N/A | N/A | Same | |||||
| S.E. | SimilaritiesProposed Convertible Abutment has same design, function, dimension range and indicationfor use; and is made with same material with same manufacturing process by samemanufacturer compared to that of the reference device Convertible Abutment, K120847. |
{28}------------------------------------------------
Image /page/28/Picture/1 description: The image shows the text 'K233194' in a simple, sans-serif font. The text is presented in a straightforward manner, with each character clearly legible. The arrangement of the characters is linear, forming a single string of alphanumeric characters.
TEM®
OSSTEM Implant Co., Ltd.
66-16, Bansong-n 513beon-gil, Haeunda-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com.
| DifferencesThe only difference is sterilization process. The proposed device is sterilized compared tothe reference device; but it has same raw material, design, manufacturing process, etc. asthat of the reference device. |
|---|
| .: Proposed Convertible Abutment and the reference device are exactly same exceptsterilization process; therefore, the proposed device is substantially equivalent to thereference device. |
6) Port Abutment
| Subject Device | Primary Predicate | Remark | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Device Name | Port Abutment | Port Abutment | Same | ||||||||||||
| 510(k) Number | - | K182091 | - | ||||||||||||
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same | ||||||||||||
| Design | Image: Subject Device Design | Image: Primary Predicate Design | Same | ||||||||||||
| 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. | Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. | Same | ||||||||||||
| Principle of Operation | Using making implant retained overdenture at maxilla/mandible. | Using making implant retained overdenture at maxilla/mandible. | Same | ||||||||||||
| Dimension (mm) | D(Ø) G/H Post 3.7 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 1.5 | D(Ø) G/H Post 3.7 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 1.5 | Same | ||||||||||||
| Material | Ti-6Al-4V (ASTM F136) | Ti-6Al-4V (ASTM F136) | Same | ||||||||||||
| Sterilization | Provided sterile (Radiation Sterile) | Sterile by end users | Different | ||||||||||||
| Shelf-life | 8 years | N/A | Different | ||||||||||||
| Surface Treatment | N/A | N/A | Same | ||||||||||||
| S.E. | SimilaritiesProposed Port Abutment has same design, function, dimension range and indication for use; and is made with same material with same manufacturing process by same manufacturer compared to that of the primary predicate Port Abutment, K182091. |
{29}------------------------------------------------
OSSTEM® IMPLANT
OSSTEM Implant Co., Ltd.
66-16, Bansong-n 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com.
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
| Differences |
|---|
| The only difference is sterilization process. The proposed device is sterilized compared tothe primary predicate; but it has same raw material, design, manufacturing process, etc. asthat of the primary predicate. |
| : Proposed Port Abutment and the primary predicate are exactly same except sterilizationprocess; therefore, the proposed device is substantially equivalent to the primary predicate. |
{30}------------------------------------------------
Image /page/30/Picture/1 description: The image contains the logo for "OSSTEM IMPLANT". The word "OSSTEM" is in orange and is in a larger font than the word "IMPLANT", which is in black. There is a registered trademark symbol next to the word "OSSTEM".
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
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
| 7) Stud Abutment | ||||
|---|---|---|---|---|
| Subject Device | Primary Predicate | Reference Device | Remark | |
| Device Name | Stud Abutment | Stud Abutment | Stud Abutment | Same |
| 510(k) Number | - | K182091 | K161689 | - |
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same |
| Design | Image: Stud Abutment | Image: Stud Abutment | Image: Stud Abutment | Same |
| Indication for Use | The OSSTEM Abutment system isintended for use with a dental implant toprovide support for prostheticrestorations such as crowns, bridges, oroverdentures. | Osstem Abutment System is intended foruse with a dental implant to providesupport for prosthetic restorations suchas crowns, bridges, or overdentures. | The OSSTEM Implant System -Abutment is intended for use with adental implant to provide support forprosthetic restorations such as crowns,bridges, or overdentures. | Same |
| Principle ofOperation | Using making stud type overdentureprosthetics | Using making stud type overdentureprosthetics | Using making stud type overdentureprosthetics | Same |
| Dimension (mm) | D(Ø) | G/H | Post | Same |
| 3.5 | 1.0, 2.0, 3.0,4.0, 5.0, 6.0 | 2.5, 3.35 | ||
| D(Ø) | G/H | Post | ||
| 3.5 | 1.0,2.0,3.0,4.0,5.0,6.0 | 2.5 | ||
| D(Ø) | G/H | Post | ||
| 3.5 | 1.0, 2.0, 3.0,4.0, 5.0, 6.0 | 3.35 | ||
| Material | Ti-6Al-4V (ASTM F136) | Ti-6Al-4V (ASTM F136) | Ti-6Al-4V (ASTM F136) | Same |
| Sterilization | Provided sterile(Radiation Sterile) | Sterile by end users | Sterile by end users | Different |
| Shelf-life | 8 years | N/A | N/A | Different |
| SurfaceTreatment | N/A | N/A | N/A | Same |
| S.E. | SimilaritiesProposed Stud Abutment has same design, function, dimension range and indication for use; and is made with same material with same manufacturing process by same manufacturer compared to that of the primary predicate and reference device Stud Abutment, K182091 and K161689.DifferencesThe only difference is sterilization process. The proposed device is sterilized compared to the primary predicate; but it has same raw material, design, manufacturing process, etc. as that of the primary predicate. | |||
| .: Proposed Stud Abutment and the primary predicate are exactly same except sterilization process; therefore, the proposed device is substantially equivalent to the primary predicate. |
Page 27 of 31
{31}------------------------------------------------
Page 28 of 31
OSSTEM® IMPLANT
OSSTEM Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haundae-gu, Busan, Republic of Korea
Tel: +82 51 850 250 Fax: +82 51 861 4693 www.osstem.com
8) Healing Abutment
| Subject Device | Reference Device | Reference Device | Remark | |
|---|---|---|---|---|
| Device Name | Healing Abutment | Healing Abutment | Healing Abutment | Same |
| 510(k) Number | - | K161604 | K163634 | - |
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Southern Implants (Pty) Ltd. | Same |
| Design | Image: Healing Abutment | Image: Healing Abutment | N/A | Same |
| Indication for Use | The OSSTEM Abutment system is | The Osstem Implant System is indicated | Southern Implants' External Hex | Same |
{32}------------------------------------------------
Image /page/32/Picture/1 description: The image contains the logo for "OSSTEM IMPLANT". The word "OSSTEM" is in a larger, orange font with a registered trademark symbol. Below it, the word "IMPLANT" is written in a smaller, black font.
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
| intended for use with a dental implant toprovide support for prostheticrestorations such as crowns, bridges, oroverdentures. | for use in partially or fully edentulousmandibles and maxillae, in support ofsingle or multiple-units restorationsincluding; cemented retained, screwretained, or overdenture restorations, andfinal or temporary abutment support forfixed bridgework. It is intended fordelayed loading. Ultra wide FixtureSystem is intended to be used in themolar region.Products with diameter of less than3.25mm should be used exclusively forthe laterl incisor in the maxilla and acentral or lateral incisor in the mandible. | Implants are intended for surgicalplacement in the upper or lower jaw toprovide a means for prostheticattachment of crowns, bridges oroverdentures utilizing delayed orimmediate loading. Southern Implants'External Hex Implants are intended forimmediate function when good primarystability with appropriate occlusalloading is achieved. | |||||
|---|---|---|---|---|---|---|---|
| Principle ofOperation | Used to make a natural soft tissue shapeuntil setting up prosthetics. It is intendeduse to combine with implanted implantafter osseointegration then removingcover screw. | Used to make a natural soft tissue shapeuntil setting up prosthetics. It is intendeduse to combine with implanted implantafter osseointegration then removingcover screw. | N/A | Same | |||
| D(Ø) | L | D(Ø) | L | D(Ø) | L | ||
| Dimension (mm) | 4.3 | 2.0, 6.0, 8.0 | 4.3 | 3.0, 4.0, 5.0, 7.0, 9.0 | 4.5 | 2.2, 3.0, 4.0, 5.0, 6.0, 8.0 | Different |
| 4.8 | 6.0, 8.0, 10.0 | 4.8 | 3.0, 4.0, 5.0, 7.0, 9.0 | 5.5 | 2.2, 3.0, 4.0, 5.0, 6.0, 8.0, 12.0 | ||
| 5.3 | 6.0, 8.0, 10.0, 11.0, 12.0 | 5.3 | 3.0, 4.0, 5.0, 7.0, 9.0 | 6.5 | 2.2, 3.0, 4.0, 5.0, 6.0, 8.0, 12.0 | ||
| 6.3 | 6.0, 8.0 | 6.3 | 3.0, 4.0, 5.0, 7.0, 9.0 | 7.5 | 2.2, 3.0, 4.0, 5.0, 6.0, 8.0, 12.0 | ||
| 7.3 | 6.0, 8.0 | 7.3 | 3.0, 4.0, 5.0, 7.0, 9.0 | ||||
| 8.3 | 6.0, 8.0 | 8.3 | 5.0 | ||||
| 9.3 | 5.0, 6.0, 8.0 | ||||||
| Material | Titanium Gr.4 (ASTM F67) | Titanium Gr.4 (ASTM F67) | CPTi, Titanium alloy, Gold, CoCr | Same | |||
| Sterilization | Provided sterile(Radiation Sterile) | Provided sterile(Radiation Sterile) | N/A | Same | |||
| Shelf-life | 8 years | 8 years | N/A | Same |
Page 29 of 31
{33}------------------------------------------------
Page 30 of 31
Image /page/33/Picture/2 description: The image contains the logo for Osstem Implant. The logo is in orange and consists of the word "OSSTEM" in a stylized font, with a small circle above the "M". 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-o 513beon-gil, Haunda-gu, Busan, Republic of Korea
Tel: +82 51 850 250 Fax: +82 51 861 4693 www.osstem.com
| SurfaceTreatment | Mini Connection: AnodizingRegular Connection : N/A | Mini Connection: AnodizingRegular Connection : N/A | N/A | Same |
|---|---|---|---|---|
| S.E. | SimilaritiesProposed Healing Abutment has same design, function and indication for use; and is made with same material with same manufacturing processby same manufacturer compared to that of the reference device Healing Abutment, K161604. | DifferencesThe added diameter and length differ from the dimension range of the reference device. However, since Healing Abutment is used temporarily to make natural soft tissue shape until setting up prosthetics, it does not required any performance. In addition, proposed lengths are within in dimension range of reference device, already cleared in K163634. Therefore, we don't consider additional performance testing. | : Proposed Healing Abutment and the reference device have common in design, function, indication for use, material, manufacturing process,manufacturer, etc.; therefore, the proposed device is substantially equivalent to the reference device. |
{34}------------------------------------------------
Image /page/34/Picture/21 description: The image contains the logo for Osstem Implant. The logo is in orange and consists of the word "OSSTEM" in all caps, with the word "IMPLANT" underneath in a smaller font. There is a degree symbol to the right of the word "OSSTEM".
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
Summary of Non-clinical Performance Testing
Non-clinical testing data were referenced by prior clearances 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 TS Abutment System has same materials, manufacturer, manufacturing process, surface treatment etc., as primary predicate and reference devices. Therefore, we didn't conduct additional biocompatibility test.
Sterilization Validation and Shelf-life
Validation of the gamma irradiation process was previously conducted for the predicated device. The processes of prediates since the clearance and the change in dimensions of the subject devices do not create the new worst case scenario or sterilization; therefore, additional validation is not required. In addition, TS Abutment System are made with titanium and titanium alloy we don't consider about shelf life of material by itself because this metal is widely known that it generally has no adversely affect by aging. Therefore we certify that product such like metal has no shelf life.
Pvrogen Test
Bacterial Endotoxin Test Report on implants according to ISO 10993-11:2006 and USP<151> referenced in K161604.
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. Processes of predicates since the clearance and the change in dimensions of the subject device do not create the new worst case scenario or bench testing.
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 Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
7. Summary of Clinical Testing
No clinical studies are submitted.
8. 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 TS Abutment System is substantially equivalent to the predicated devices as herein.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)