SS SA Fixture
Device Facts
| Record ID | K163557 |
|---|---|
| Device Name | SS SA Fixture |
| Applicant | Osstem Implant Co., Ltd. |
| Product Code | DZE · Dental |
| Decision Date | May 15, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Osstem Implant is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra Wide Fixture System is intended to be used in the molar region.
Device Story
SS SA Fixture is a titanium dental implant surgically placed into the jaw bone to support prosthetic restorations. It features a sandblasted and acid-etched (SA) surface and an internal octagonal connection. The device is supplied sterile and is intended for delayed loading in the molar region. It is used by dental professionals in a clinical setting. The implant provides a stable foundation for crowns, bridges, or overdentures, restoring masticatory function and aesthetics for edentulous patients. The healthcare provider selects the appropriate fixture size based on the patient's anatomical needs and performs the surgical placement. The device's mechanical stability supports the long-term integration of the prosthetic restoration.
Clinical Evidence
No clinical studies were submitted. Substantial equivalence is supported by bench testing, including biocompatibility, sterilization validation, surface characterization, Bone to Implant Contact (BIC) analysis, surface area analysis, pullout testing, and fatigue testing conducted per ISO 14801.
Technological Characteristics
Material: Pure Titanium Grade 4 (ASTM F67). Surface: Sandblasted and Acid etched (SA). Connection: Internal octagonal. Design: Tapered body, self-tapping, non-submerged. Sterilization: Gamma radiation. Connectivity: N/A (mechanical device).
Indications for Use
Indicated for partially or fully edentulous patients requiring single or multiple-unit restorations, including cemented, screw-retained, or overdenture restorations, and abutment support for fixed bridgework. Intended for delayed loading. Ultra Wide Fixture System is indicated for use in the molar region.
Regulatory Classification
Identification
An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.
Special Controls
*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
Predicate Devices
- ET/SS Implant System (K120847)
Reference Devices
- OSSTEM Implant System (K161604)
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 15, 2017
Osstem Implant Co., Ltd. % David Kim Manager Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030
Re: K163557
Trade/Device Name: SS SA Fixture Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: April 14, 2017 Received: April 14, 2017
Dear David 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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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.
Michael J. Ryan -S
for 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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## Indications for Use
510(k) Number (if known) K163557
Device Name SS SA Fixture
Indications for Use (Describe)
The Osstem Implant is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra Wide Fixture System is intended to be used in the molar region.
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) |
|----------------------------------------------|---------------------------------------------|
|----------------------------------------------|---------------------------------------------|
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# 510(k) Summary
Date: May 11, 2017
#### 1. Company and Correspondent making the submission:
| - Submitter's Name: | OSSTEM Implant Co., Ltd. |
|-------------------------|-------------------------------------------------------------------------|
| - Address: | 66-16, Bansong-ro 513beon-gil, Haeundae-gu,<br>Busan, Republic of Korea |
| - Contact: | Mr. Hee Kwon Son |
| - Phone: | +82 51 850 2575 |
| - Correspondent's Name: | HIOSSEN Inc. |
| - Address: | 85 Ben Fairless Dr. Fairless Hills, PA 19030 |
| - Contact: | DAVID KIM |
| - Phone: | 267 759 7031 |
- 2. Device:
Trade or (Proprietary) Name : SS SA Fixture Common or usual name : Dental Implant Classification Name : Endosseous Dental Implant Regulation Number : 21CFR872.3640 Device Classification: Class II Primary Product Code: DZE Subsequent Product Code: NHA
- 3. Predicate Device:
Substantial equivalence is claimed to the following devices: Primary Predicate K120847, ET/SS Implant System, OSSTEM Implant Co., Ltd.
Reference predicate K161604, OSSTEM Implant System, OSSTEM Implant Co., Ltd.
### 4. Description:
The SS SA Fixture is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated.
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Image /page/4/Picture/1 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The logo is on the left side of the image, and the company name is in large, bold letters. 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 51 850-4341, and the website address is www.osstem.com.
The SS SA Fixture is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
#### 1) SSIII SA Ultra-Wide Fixture
| Device<br>Description | Intended to be surgically placed in the bone of the upper or lower jaw<br>arches. Fixture is supplied sterile. Only straight type abutments are to<br>be used with the Ultra-Wide Fixture System. | |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Material | Pure Titanium (ASTM F 67) | |
| Surface | SA surface treatment | |
| | Diameter (mm) | Length (mm) |
| Dimension | 5.96, | 6, 8.5 |
| | 6.0 | 7 |
| | 5.95 | 10 |
| | 5.92 | 11.5, 13 |
| | 6.93 | 6 |
| | 6.8 | 7, 8.5, 10, 11.5, 13 |
## - Substantial Equivalence Matrix
| | SS SA Fixture<br>(SSIII SA Ultra Wide<br>Fixture) | Primary Predicate<br>ET/SS Implant<br>System<br>(SSII/III SA Fixture) | Reference predicate<br>OSSTEM Implant<br>System | |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| 510(K) No. | New Device | K120847 | K161604 | |
| Manufacturer | OSSTEM Implant<br>Co., Ltd. | OSSTEM Implant<br>Co., Ltd. | OSSTEM Implant<br>Co., Ltd. | Same |
| Indication for<br>use | The Osstem Implant is<br>indicated for use in<br>partially or fully<br>edentulous mandibles<br>and maxillae, in support<br>of single or multiple-<br>unit restorations<br>including; cemented<br>retained, screw retained,<br>or overdenture<br>restorations, and final or<br>temporary abutment<br>support for fixed<br>bridgework. It is<br>intended for delayed<br>loading. Ultra Wide<br>Fixture System is<br>intended to be used in<br>the molar region. | ET/SS Implant System<br>is indicated for use in<br>partially or fully<br>edentulous mandibles<br>and maxillae, in support<br>of single or multiple-<br>unit restorations<br>including; cemented<br>retained, screw retained,<br>or overdenture<br>restorations, and final or<br>temporary abutment<br>support for fixed<br>bridgework. It is<br>intended for delayed<br>loading. The abutment<br>is intended for use with<br>a dental implant fixture<br>to provide support for<br>prosthetic restorations | The Osstem Implant<br>System is indicated for<br>use in partially or fully<br>edentulous mandibles<br>and maxillae, in support<br>of single or multiple-<br>units restorations<br>including; cemented<br>retained, screw retained,<br>or overdenture<br>restorations, and final or<br>temporary abutment<br>support for fixed<br>bridgework. It is<br>intended for delayed<br>loading. Ultra wide<br>Fixture System is<br>intended to be used in<br>the molar region.<br>Products with diameter | Same |
| | | such as crowns, bridges,<br>or overdenture. | of less than 3.25mm<br>should be used<br>exclusively for the<br>lateral incisor in the<br>maxilla and a central or<br>lateral incisor in the<br>mandible | |
| Surgery type | One stage Surgery | One stage Surgery | One or two stage<br>Surgery | Same |
| Structure | - Non Submerged<br>Fixture<br>- Self tapping<br>- Internal Octagonal<br>connection<br>- Taper Body | - Non Submerged<br>Fixture<br>- Self tapping<br>- Internal Octagonal<br>connection<br>- Straight/Taper body<br>shape | - Internal Hex-<br>connected<br>- Submerged Fixture<br>- Straight/Taper body<br>shape | Same |
| Platform<br>(D) (mm) | 6 | 4.8~6.0 | N/A | Included in<br>predicate |
| Body<br>Diameter<br>(D) (mm) | 5.92, 5.95, 5.96, 6.0,<br>6.93, 6.8 | 4.1~4.9/3.75~5.0 | 3.2, 3.5, 3.75, 3.77, 4.2,<br>4.25, 4.4, 4.45, 4.6,<br>4.63, 4.65, 4.8, 4.9,<br>5.05, 5.08, 5.1, 5.25,<br>6.2, 7.1 | Included in<br>Reference<br>predicate |
| Length (mm) | 6, 7, 8.5, 10, 11.5, 13 | 6~15.0 | 6.2, 7.0, 8.5, 10.0, 11.5,<br>13.0, 15.0, 18.0 | Included in<br>predicate |
| Material of<br>Fixture | Pure Titanium Grade 4<br>(ASTM F67) | Pure Titanium Grade 4<br>(ASTM F67) | Pure Titanium Grade 4<br>(ASTM F67) | Same |
| Surface | SA | SA | SA | Same |
| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile | Same |
| Shelf life | 8years | 5years | 8years | Same with<br>Reference<br>predicate |
| S E | Same<br>SS SA Fixture have same connection structure, material, manufacture process (including<br>surface treatment), principles of operation, Technological Characteristics and indication for use<br>with ET/SS Implant System (SSII/III SA Fixture)<br>And length of SS SA Fixture is also included in primary predicate ET/SS Implant System<br>(SSII/III SA Fixture)<br>Different<br>Diameter of SS SA fixture is bigger than primary predicate ET/SS Implant System (SSII/III SA<br>Fixture) but Diameter of SS SA fixture is included in range of reference predicate diameter,<br>OSSTEM Implant System.<br>Therefore SSIII SA Ultra Wide Fixture of SS SA Fixture is substantially equivalent to the<br>predicate devices | | | |
Letter(8.5 X 11in)
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Image /page/5/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 small superscript "6" next to the word "OSSTEM".
OSSTEM Implant Co., Ltd.
Section 007
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
## 5. Indication for use:
The Osstem Implant is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for
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Image /page/6/Picture/1 description: The 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 phone number is +82 51 850-2500, the fax number is +82 51 850-4341, and the website is www.osstem.com.
fixed bridgework. It is intended for delayed loading. Ultra Wide Fixture System is intended to be used in the molar region.
#### 6. Summary of nonclinical testing
The following nonclinical testing data were provided or relied upon in support of the Substantial equivalence determination.
#### Biocompatibility
Biocompatibility testing on the SS SA Fixture was previously conducted. As the material of construction and manufacturing processes are the same as the predicate device, ET/SS Implant System, OSSTEM Implant Co., Ltd., K120847 and OSSTEM Implant System, OSSTEM Implant Co., Ltd., K161604.
Therefore, no additional testing is required to support the biological safety of the subject devices.
#### Sterilization validation
Validation of the gamma irradiation process was previously conducted for the predicate devices, OSSTEM Implant System, OSSTEM Implant Co., Ltd., K161604. There has been no change to the manufacturing, sterilization processes since then; therefore, additional validation is not required.
#### Surface treatment characterization testing
SS SA Fixture has SA (Sandblasted and Acid etched surface) surface treatment that is exactly same with the predicate devices, ET/SS Implant System, OSSTEM Implant Co., Ltd., K120847 and OSSTEM Implant System, OSSTEM Implant Co., Ltd., K161604. There has been no change to the manufacturing or surface treatment processes since then; therefore, additional characterization testing is not required.
#### Bone to Implant Contact (BIC) analysis
BIC analysis is conducted with SS SA Fixture containing implants of lengths less than 7mm. We compared the BIC value and confirmed the substantial equivalence status with the predicate device; ET/SS implant System, OSSTEM Implant Co., Ltd., K120847.
#### Surface area analysis
Surface area analysis is conducted with SS SA Fixture containing implants of lengths less than 7mm. We compared the surface area and confirmed the substantial equivalence status with the predicate device; ET/SS implant System, OSSTEM Implant Co., Ltd., K120847.
#### Pullout test
Pullout force test was conducted with SS SA Fixture containing implants of lengths less than 7mm. We compared the pullout force value and confirmed the substantial equivalence status with the predicate device; ET/SS implant System, OSSTEM Implant Co., Ltd., K120847.
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Image /page/7/Picture/1 description: The image contains two logos. The first logo on the left says "OSSTEM IMPLANT" with "OSSTEM" in orange and "IMPLANT" in gray. The second logo on the right says "OS" in large black font, followed by the number "66-16."
## Fatigue test
The Fatigue testing was considered according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801 Dentistry - Fatigue test for endosseous dental implants with the worst case scenario. SS SA Fixture has bigger diameter than the predicate device, ET/SS Implant System, OSSTEM Implant Co., Ltd., K120847. The result of SS SA Fixture static and dynamic compression - bending test will be higher than this predicate; therefore, we do not consider additional fatigue test.
- 7. Summary of clinical testing No clinical studies are submitted.
- 8. 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 Implant Co., Ltd. concludes that the SS SA Fixture is substantially equivalent to the predicate devices as described herein.
