Who is the manufacturer of US SA Implant System?

Osstem Implant Co., Ltd. filed the 510(k) submission for US SA Implant System (K161103).

What is the FDA product code for US SA Implant System?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for US SA Implant System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like US SA Implant System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

US SA Implant System

Q: What are the predicate devices for US SA Implant System?

HU II / HS II FIXTURE SYSTEM (K080387).

K161103 · Osstem Implant Co., Ltd. · DZE · Feb 2, 2017 · Dental

Device Facts

Record ID	K161103
Device Name	US SA Implant System
Applicant	Osstem Implant Co., Ltd.
Product Code	DZE · Dental
Decision Date	Feb 2, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The US SA Implant System 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 fixed bridgework. It is intended for delayed loading. The abutment is intended for use with a dental implant fixture to provide support for prosthetic restorations such as bridges, or overdenture.

Device Story

US SA Implant System comprises titanium dental implants and abutments for surgical placement in jaw bone; supports prosthetic restorations (bridges, overdentures). Fixtures feature external hex-connection, submerged design, straight or tapered body, and self-tapping 3-sided cutting edges. Abutments (Multi Angled) allow path adjustment for multi-unit restorations. Used by dental professionals in clinical settings. System provides structural support for dental prosthetics; benefits patients by restoring function in edentulous areas. Device is supplied sterile; requires surgical implantation.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including fatigue testing per FDA guidance for root-form endosseous dental implants and sterilization validation per ISO 11137 and ISO 17665.

Technological Characteristics

Materials: Pure Titanium (ASTM F67) for fixtures, Titanium Alloy (ASTM F136) for abutments. Design: External hex-connected, submerged, straight/tapered body, self-tapping. Surface: Sandblasted and Acid-etched (SA). Sterilization: Radiation (fixtures) and Steam. Dimensions: Diameters 3.5mm-5.13mm, Lengths 7mm-18mm.

Indications for Use

Indicated for partially or fully edentulous patients (mandibles and maxillae) requiring single or multiple-unit restorations, including cemented, screw-retained, or overdenture restorations, and fixed bridgework support. Intended for delayed loading.

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

HU II / HS II FIXTURE SYSTEM (K080387)

Reference Devices

Multi Angled Abutment (K123755)
TS Fixture System (K121995)
US.SS.GS System (K073247)
3i OSSEOTITE Dental Implants (K063286)
HIOSSEN Implant System (K140934)
Hiossen Prosthetic system (K140507)
ET II SA Fixture (K140934)

Related Devices

K121585 — TS IMPLANT SYSTEM · Osstem Implant Co., Ltd. · Jan 7, 2013
K202039 — Honorst Implant System · Medimecca Co., Ltd. · Sep 25, 2020
K191443 — MSDI Dental Implants System · Medical Systems and Devices International , Ltd. · Jun 26, 2020
K140934 — HIOSSEN IMPLANT SYSTEM · Hiossen, Inc. · Nov 12, 2014
K151588 — maxFit II Dental Implant System · Taiwan Implant Technology Company, Ltd. · Apr 25, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 2, 2017 OSSTEM IMPLANT Co., Ltd. c/o Mr. David Kim Manager HiOSSEN Inc. 85 Ben Fairless Dr. Fairless Hills. Pennsylvania 19030 Re: K161103 Trade/Device Name: US SA Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: January 6, 2017 Received: January 6, 2017 Dear Mr. Kim: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ 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 yours, 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 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The logo includes the company name and the word "IMPLANT" in orange. The address is listed as 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea, and the telephone number is +82 51 850-2500, the fax number is +82 51 850-4341, and the website is www.osstem.com. # Indications for Use Statement # Indications for Use 510(k) Number K 161103 Device Name : US SA Implant System Indication for use : The US SA Implant System 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 fixed bridgework. It is intended for delayed loading. The abutment is intended for use with a dental implant fixture to provide support for prosthetic restorations such as bridges, or overdenture. Prescription Use (Per 21CFR801 Subpart D) OR Over-The-Counter Use (Per 21CFR807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) QS-QI-505-2(Rev.0) {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Osstem Implant. The logo is orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. The logo is simple and modern. STEM Implant Co., Ltd. 6-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com # 510(k) Summary Date: February 1, 2017 1. Company and Correspondent making the submission: | - Submitter's Name : | OSSTEM Implant Co., Ltd. | |-------------------------|-------------------------------------------------------------------------| | - Address : | 66-16, Bansong-ro 513beon-gil, Haeundae-gu, 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 : | US SA Implant System | |-------------------------------|---------------------------| | Common or usual name : | Dental Implant | | Classification Name : | Endosseous Dental Implant | | Regulation Number: | 21CFR872.3640 | | Regulatory Class: | Class II | | Product Code: | DZE, NHA | - 3. Predicate Device : - Primary predicate HU II / HS II FIXTURE SYSTEM, HiOSSEN Inc, K080387 - Reference predicate Multi Angled Abutment, OSSTEM Implant Co., Ltd., K123755 TS Fixture System, OSSTEM Implant Co., Ltd., K121995 US.SS.GS System, OSSTEM Implant Co., Ltd., K073247 3i OSSEOTITE Dental Implants, Implant Innovations, Inc, K063286 HIOSSEN Implant System, HIOSSEN Inc., K140934 # 4. Description : The US SA Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. QS-QI-505-3(Rev.0) {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, gray, sans-serif font. The logo is simple and modern. OSSTEM Implant Co., Ltd. 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated. The US SA Implant System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The US SA Implant System is substantially equivalent in design, function and intended use to the HU II / HS II Fixture System ( K080387) of Osstem Implant Co., Ltd., the TS Fixture System (K121995) of OSSTEM Implant Co., Ltd., the Multi Angled Abutment (K123755) of OSSTEM Implant Co., Ltd. and HIOSSEN Implant System (K140934) of HIOSSEN Inc. The US Multi Angled Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. The US Multi Angled Abutment is used with Multi Ti Cylinder or US Esthetic Low Cylinder that is predicated by 510(K), K140507 Hiossen Prosthetic system and connected to USII SA Fixture and USIII SA Fixture. The US II SA and US III SA fixtures are only compatible with the straight Cemented Abutment and straight UCLA Temporary Abutment from K073247 and the US Multi Angled Abutment included in this submission. | Item | Content | | | |---------------------|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| | US II SA Fixture | Description | External Hex-connected Submerged Fixture Straight body shape 3 side cutting edge with self-tapping | | | | Material | Titanium (ASTM F67) | | | | Diameter and Length | 3.5mm X 8.5, 10, 11.5, 13, 15, 18 mm 4.1mm X 7, 8.5, 10, 11.5, 13, 15, 18 mm 4.45mm X 7, 8.5, 10, 11.5, 13, 15, 18 mm 4.9mm X 7, 8.5, 10, 11.5, 13, 15, 18 mm (wide) 4.9mm X 7, 8.5, 10, 11.5, 13, 15, 18 mm (wide ps) | | | | US III SA Fixture | Description | External Hex-connected Submerged Fixture Taper body shape 3 sided cutting edge with self-tapping | | | | Material | Titanium (ASTM F67) | | Diameter and Length | | 3.75mm X 8.5, 10, 11.5, 13 mm 4.23mm X 8.5, 10, 11.5 mm 4.27mm X 7 mm 4.65 mm X7, 8.5, 10, 11.5, 13 mm 5.05mm X 10, 11.5 mm (wide) 5.1mm X 7, 13 mm (wide) 5.13mm X 8.5 mm (wide) 5.05mm X 10, 11.5 mm (wide ps) 5.1mm X 7, 13 mm (wide ps) 5.13mm X 8.5 mm (wide ps) | | QS-QI-505-3(Rev.0) {5}------------------------------------------------ Image /page/5/Picture/0 description: The image features 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. Below "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern, and the orange color is eye-catching. **OSSTEM Implant Co., Ltd.** OSSTEM Implant Co., Ltd. 66-16, Bansong-ro 513beon-gil, Haeunda-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com | Cover Screw | Description | To be used to protect the exposed platform of the implant during healing period | | |-----------------------------|-------------|----------------------------------------------------------------------------------------------|--| | | Material | Titanium (ASTM F67) | | | | Diameter | 6.4mm, 7.7mm | | | | Length | 5.9mm | | | US Multi Angled Abutment | Description | US Multi Angle Abutment is used to adjust path of prosthesis for multi-unit restorations. | | | | Material | Titanium Alloy (ASTM F 136) | | | | Component | US Multi Angled Abutment Screw. | | | | Diameter | 3.4mm, 4.0mm, 4.1mm | | | | Angle | 17°, 30° | | | Multi Ti Cylinder | Description | Multi Ti Cylinder is used to make final prosthesis using US Multi Angled Abutment | | | | Material | Titanium Alloy (ASTM F 136) | | | | Component | Consists of Multi Ti Cylinder Screw. | | | | Diameter | 4.8mm | | | | Length | 7.0mm | | # - Substantial Equivalence Matrix | | | Predicate devices | | | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | Primary predicate | Reference predicate | Reference predicate | | | US SA Implant System USII SA Fixture USIII SA Fixture | HUII/ HSII FIXTURE SYSTEM HUII Fixture (K080387) | TS Fixture System TSII/III SA Fixture (K121995) | ET II SA Fixture (K140934) | | Design | Image: USII and USIII | Image: HUII | Image: TSII and TSIII | Image: ETII | | Intended use | The US SA Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple- unit restorations including: cemented | The HUII / HSII Fixture System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple- unit restorations | The TS Fixture System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple- unit restorations including : cemented | The ETII Fixture System 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 fixed bridgework. It is intended for delayed loading. The abutment is intended for use with a dental implant fixture to provide support for prosthetic | including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The HU II / HS II Fixture System is for one and two stage surgical procedures. It is not for immediate load. | retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading | retained, screw 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. | | | restorations such as bridges, or overdenture. | | | | | Surgery type | One and two stage Surgery | One and two stage Surgery | One and two stage Surgery | One and two stage Surgery | | Structure | - External Hex- connected - Submerged Fixture - Straight / Taper body shape - 3 sided cutting edge with self-tapping | -Submerged Fixture -Body type : Straight Body -Self tapping -Connection : External hex- connected | - Internal Hex- connected - Submerged Fixture - Straight / Taper body shape - 3 sided cutting edge with self-tapping | - Internal Hex- connected - Submerged Fixture - Straight body shape - 3 sided cutting edge with self- tapping | | Platform (D) | 3.6, 4.2, 5.1, 5.2 | 3.5~5.1 | N/A | N/A | | Body Diameter (D) | 3.5, 4.1, 4.45, 4.9 3.75, 4.23, 4.27, 4.65, 5.05, 5.1, 5.13 | 3.5~5.5 | TS II SA: 3.5, 4.2, 4.4, 4.9 TS III SA: 3.77, 3.75, 4.25, 4.2, 4.65, 4.63, 4.6, 5.1, 5.08, 5.05, | 3.5, 4.2, 4.45, 4.9, 5.0 | | Length (mm) | 7, 8.5, 10, 11.5, 13, 15, 18 | 7.0~15.0 | 7.0~15 | 6.2 ~ 18.2 | | Material of Fixture | Pure Titanium Grade 4 (ASTM F67) | Pure Titanium Grade 4 (ASTM F67) | Pure Titanium Grade 4 (ASTM F67) | Pure Titanium Grade 4 (ASTM F67) | | Surface | SA | RBM | SA | SA | | Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile | Radiation Sterile | | Shelf life | 8years | 3 years | 8 years | 8 years | | SE | USII SA Fixture and USIII SA Fixture have the same material, indication for use, connection structure as the HUII Fixture in the HU II / HS II Fixture System (K080387) except surface treatment. surface treatment of USII SA Fixture is different from Primary predicate, HUII Fixture but the surface treatment of USII SA Fixture and USIII SA Fixture is the same with surface treatment of TS Fixture System (K121995) | | | | {6}------------------------------------------------ K161103 Image /page/6/Picture/1 description: The image contains 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, gray, sans-serif font. There is a small orange circle with a degree symbol in the upper right corner of the logo. OSSTEM Implant Co., Ltd. 66-16, Bansong-ro 513beon-gil, Haeunda-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com {7}------------------------------------------------ Image /page/7/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. The logo is simple and modern. OSSTEM Implant Co., Ltd. 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com And Diameter size and length of US SA Implant System are included dimension range of predicate, HUII Fixture in the HU II / HS II Fixture System (K080387) and ET II SA Fixture (K140934) Therefore we state that US SA Implant System is substantially equivalent to the predicate devices as described herein. | | US Multi Angled Abutment | Predicate devices | | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | Primary predicate Multi Angled Abutment | Reference predicate Cement Abutment | | Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | | 510(k) Number | New | K123755 | K073247 | | Design | Image: US Multi Angled Abutment Design | Image: Multi Angled Abutment Design | Image: Cement Abutment Design | | Intended use | US Multi Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as bridges, or overdentures. | Multi Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as bridges, or overdentures. | Cement Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. | | Abutment Angle(°) | 17, 30 | 17, 30 | 0 | | platform(Ø) | 4.9 | 4.8 | - | | connection | External Hex-connected Compatible with USII SA Fixture | Internal Hex-connected Compatible with TSII SA Fixture | External Hex-connected Compatible with USII SA Fixture | QS-QI-505-3(Rev.0) {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with the letters slightly overlapping each other. Below "OSSTEM" is the word "IMPLANT" in gray. To the right of the word "OSSTEM" is a small orange circle. STEM Implant Co., Ltd Bansong-ro 513beon-gil. Haeundae-gu. Busan, Republic of Korea 1: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com | Connection | US Multi Angled Abutment has the same material, indication for use, function and similar design as the Multi Angled Abutment (K123755) except connection structure. But connection structure is exactly same with Cement Abutment, K073247 In accordance with difference of connection and shape, we conducted fatigue test to confirm proposed device strength | |------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| ### 5. Indication for use : The US SA Implant System 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 fixed bridgework. It is intended for delayed loading. The abutment is intended for use with a dental implant fixture to provide support for prosthetic restorations such as bridges, or overdenture. # 6. Review : The US SA Implant System has same material and indication for use and similar design and technological characteristics as the predicate device. ### 7. Summary of nonclinical testing Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence: Fatigue testing was conducted with subject devices according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment". Gamma Sterilization Validation was performed with Fixture System according to ISO 11137-1, ISO 11137-2 and ISO 11137-3. Steam sterilization validation was provided according to ISO 17665-1 and ISO 17665-2. Subject devices are made of the same materials, manufacturing process, chemical composition, and body contact with the predicate devices, the TS Fixture System, OSSTEM Implant Co., Ltd., K121995 and Multi Angled Abutment, OSSTEM Implant Co., Ltd., K123755 therefore US SA Implant System is substantially equivalent to the predicate devices in biocompatibility, surface coating characterization # 8. Summary of clinical testing No clinical studies are submitted - 9. Conclusions In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Osstem Implant Co., Ltd. concludes that the US SA Implant System is substantially equivalent to the predicate devices as described herein.