Osstem Implant System

K222778 · Osstem Implant Co., Ltd. · DZE · Sep 23, 2023 · Dental

Device Facts

• Record ID: K222778
• Device Name: Osstem Implant System
• Applicant: Osstem Implant Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Sep 23, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Osstem Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-units restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra wide Implant System is intended to be used in the molar region. Products with diameter of less than 3.25mm should be used exclusively for the lateral incisor in the maxilla and a central or lateral incisor in the mandible.

Device Story

Osstem Implant System consists of titanium dental implants surgically placed into jaw bone to support prosthetic restorations. Implants are placed in partially or fully edentulous mandibles and maxillae; intended for delayed loading. System includes various implant models (TSIII, TSIV, SSII, SSIII) and scan healing abutments. Operated by dental professionals in clinical settings. Output is a stable fixture for prosthetic attachment. Benefits include restoration of dental function and aesthetics. Device is non-active; no software or algorithms involved.

Clinical Evidence

No clinical studies submitted. Substantial equivalence supported by non-clinical bench testing, including fatigue testing per ISO 14801:2016, and leveraging previously cleared biocompatibility, sterilization, and shelf-life data.

Technological Characteristics

Materials: Titanium Grade 4 (ASTM F67) and Titanium Alloy (ASTM F136). Surface: SA (Sand-blasted and Acid-etched). Energy source: None (mechanical). Connectivity: None. Sterilization: Radiation sterile. Form factor: Root-form endosseous dental implants with various diameters and lengths.

Indications for Use

Indicated for partially or fully edentulous mandibles and maxillae in patients requiring single or multiple-unit restorations (cemented, screw-retained, or overdenture) or fixed bridgework. Ultra-wide implants are for molar regions. Implants <3.25mm are restricted to maxillary lateral incisors and mandibular central/lateral incisors.

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

• OSSTEM Implant System (K161604)
• TS Fixture System (K121995)
• SS SA Fixture (K163557)

Reference Devices

• External Hex Implants (K163634)

Submission Summary (Full Text)

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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 & Human Services logo. To the right of that is the FDA logo, which 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.

Osstem Implant CO., LTD. % Peter Lee RA/QA Manager HioSSEN Inc. 85 Ben Fariless Dr. Fariless Hills, Pennsylvania 19030

Re: K222778

Trade/Device Name: Osstem Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: July 3, 2023 Received: August 9, 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

9/23/23

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Sherrill Lathrop Blitzer

for Andrew 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

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# Indications for Use

510(k) Number (if known)

K222778

Device Name OSSTEM Implant System

#### Indications for Use (Describe)

The Osstem Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-units restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra wide Implant System is intended to be used in the molar region.

Products with diameter of less than 3.25mm should be used exclusively for the lateral incisor in the maxilla and a central or lateral incisor in the mandible.

X 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: September 23, 2023

#### Company and Correspondent making the submission 1.

- 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] -Phone : Correspondent's Name Hiossen Inc. : --Address : 85 Ben Fairless Dr. Fairless Hills, PA 19030 Contact Mr. Peter Lee -: -Phone [phone] :
#### 2. Proposed Device

- -Trade or (Proprietary) Name Osstem Implant System : -Classification Name Endosseous dental implant : Regulation Number 21CFR872.3640 -. •
- Devce Classification Class II -:
- Classification Product Code -DZE :
- -Subsequent Product Code NHA . •

#### 3. Predicate Device

| Primary Predicate | |
|-------------------|-----------------------|
| K161604 | OSSTEM Implant System |
| Reference Device | |
| K121995 | TS Fixture System |
| K163557 | SS SA Fixture |
| K163634 | External Hex Implants |

#### 4. Indication for use

The Osstem Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-units restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra wide Implant System is intended to be used in the molar region.

Products with diameter of less than 3.25mm should be used exclusively for the lateral incisor in the maxilla and a central or lateral incisor in the mandible.

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Image /page/4/Picture/2 description: The image contains 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 circle above the right side of the word "OSSTEM".

OSSTEM Implant Co., Ltd. 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea

Tel: [phone] Fax: [phone] www.osstem.com

# 5. Device Description

The Osstem 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. The Ultra-Wide implants are intended to be used only to replace molar teeth and angled abutments are not to be used with the Ultra-Wide implants.

Osstem Implant System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.

| Device | Description | Content |
|---------------------------------|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| TSIII SA Implant | Description | Intended to be surgically placed in the bone of the upper or lower jaw arches. |
| | Material | Titanium Grade 4 (ASTM F67) |
| | Surface | SA surface treatment |
| | Diameter (D) and Length (L) | ø3.75 x L 18, 20 mm<br>ø3.77 x L 7 mm<br>ø4.25 x L 7 mm<br>ø4.65 x L 7 mm<br>ø5.45 x L 10, 11.5, 13, 15 mm<br>ø5.48 x L 8.5 mm<br>ø5.5 x L 7mm |
| TSIII SA Implant (Non-Hex) Ø3.2 | Description | Intended to be surgically placed in the bone of the upper or lower jaw arches. |
| | Material | Titanium Alloy (ASTM F136) |
| | Surface | SA surface treatment |
| | Diameter (D) and Length (L) | ø3.2 x L 8.5, 10, 11.5, 13, 15 mm |
| TSIII SA Implant (Non-Hex) | Description | Intended to be surgically placed in the bone of the upper or lower jaw arches. |
| | Material | Titanium Grade 4 (ASTM F67) |
| | Surface | SA surface treatment |
| | Diameter (D) and Length (L) | ø3.75 x L 10, 11.5, 13 mm<br>ø3.77 x L 8.5 mm<br>ø3.8 x L 8.5, 10, 11.5, 13, 15, 18 mm<br>ø4.2 x L 10, 11.5, 13, 15, 18 mm<br>ø4.25 x L 7, 8.5 mm<br>04.6 x L 10, 11.5, 13, 15, 18 mm<br>ø4.63 x L 8.5 mm<br>ø4.65 x L 7 mm<br>05.05 x L 10, 11.5, 13, 15, 18 mm<br>05.08 x L 8.5 mm<br>ø5.1 x L 7 mm |
| TSIV SA Implant | Description | Intended to be surgically placed in the bone of the upper or lower jaw arches. |
| | Material | Titanium Grade 4 (ASTM F67) |
| | Surface | SA surface treatment |
| | Diameter (D) and Length (L) | ø4.4 x L 18 mm<br>04 8 x L. 18 mm |

The specifications of the proposed device are as follow;

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Image /page/5/Picture/3 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, gray font. The logo is simple and modern.

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: [phone] Fax: [phone] www.osstem.com

| TS Scan Healing Abutment | Description | Ø5.25 x L 18 mm<br>It is used to make a natural soft tissue shape before<br>setting up prosthetics and removing cover screw after<br>osseointegration. | | | | | | | | | | | | | | | |
|-----------------------------------|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| | Material | Titanium Grade 4 (ASTM F67) | | | | | | | | | | | | | | | |
| | Diameter (D) and<br>Length (L) | Ø4.3 x L 5.5, 5.6, 6.5, 6.6, 7.5, 7.6, 9.5, 9.6, 11.6 mm<br>Ø4.8 x L 5.5, 5.6, 6.5, 6.6, 7.5, 7.6, 9.5, 9.6, 11.5 mm<br>Ø5.3 x L 5.5, 6.5, 7.5, 9.5, 11.5 mm<br>Ø6.3 x L 5.5, 6.5, 7.5, 9.5, 11.5 mm<br>Ø7.3 x L 5.5, 6.5, 7.5, 9.5 mm | | | | | | | | | | | | | | | |
| TS Scan Healing Abutment<br>Screw | Description | It is used to make a natural soft tissue shape before<br>setting up prosthetics and removing cover screw after<br>osseointegration. | | | | | | | | | | | | | | | |
| | Material | Titanium Alloy (ASTM F136) | | | | | | | | | | | | | | | |
| | Diameter (D) and<br>Length (L) | Ø2.2 x L 10, 11, 12, 14, 16 mm<br>Ø2.3 x L 8, 9, 10, 12, 14 mm | | | | | | | | | | | | | | | |
| SSII SA Implant | Description | Intended to be surgically placed in the bone of the<br>upper or lower jaw arches. | | | | | | | | | | | | | | | |
| | Material | Titanium Grade 4 (ASTM F67) | | | | | | | | | | | | | | | |
| | Surface | SA surface treatment | | | | | | | | | | | | | | | |
| | Dimension | G/H D L 1.8 4.8, 6.0 7, 8.5, 10, 11.5, 13, 15mm 2.8 4.8, 6.0 7, 8.5, 10, 11.5, 13, 15mm | | | | | | | | | | | | | | | |
| SSIII SA Implant | Description | Intended to be surgically placed in the bone of the<br>upper or lower jaw arches. | | | | | | | | | | | | | | | |
| | Material | Titanium Grade 4 (ASTM F67) | | | | | | | | | | | | | | | |
| | Surface | SA surface treatment | | | | | | | | | | | | | | | |
| | Dimension | G/H D L 0.8 4.8, 6.0 7 mm 1.8 4.8, 6.0 7, 8.5, 10, 11.5, 13, 15 mm 2.0 6.0 15.0 mm 2.8 4.8, 6.0 7, 8.5, 10, 11.5, 13, 15 mm | | | | | | | | | | | | | | | |
| SSIII SA Ultra-Wide Implant | Description | Intended to be surgically placed in the bone of the<br>upper or lower jaw arches. | | | | | | | | | | | | | | | |
| | Material | Titanium Grade 4 (ASTM F67) | | | | | | | | | | | | | | | |
| | Surface | SA surface treatment | | | | | | | | | | | | | | | |
| | Dimension | G/H D L 1.8 6.0 7, 8.5, 10, 11.5, 13 mm 2.8 6.0 7, 8.5, 10, 11.5, 13 mm | | | | | | | | | | | | | | | |

#### 6. Substantial Equivalence Matrix

These subject devices are adding additional dimensions to otherwise identical implant bodies cleared in past 510(k)s; therefore, indication for use, shape, connection structure, material, surface treatment, manufacturer and etc. are the same with predicate devices except dimension of additional products.

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Image /page/6/Picture/3 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is in orange, with a small superscript circle containing the number 6. Below the brand name, the word "IMPLANT" is written in gray, in a smaller font size. The logo is simple and clean, with a focus on the brand name.

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: [phone] Fax: [phone] www.osstem.com

| 1) TSIII SA Implant | | | | | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | Subject device | Primary predicate<br>device | Predicate device | Reference device | Remark |
| Device Name | TSIII SA Implant | TSIII SA Implant | TSIII SA Implant | External Hex<br>Implants | Same |
| 510(k)<br>Number | - | K161604 | K121995 | K163634 | - |
| Manufacturer | Osstem Implant Co.,<br>Ltd | Osstem Implant Co.,<br>Ltd | Osstem Implant Co.,<br>Ltd | NA | Same |
| Design | Image: Implant design | Image: Implant design | Image: Implant design | NA | Similar |
| Indication for<br>Use | The Osstem Implant<br>System is indicated<br>for use in partially or<br>fully edentulous<br>mandibles and<br>maxillae, in support<br>of single or multiple-<br>units restorations<br>including; cemented<br>retained, screw<br>retained, or<br>overdenture<br>restorations, and final<br>or temporary<br>abutment support for<br>fixed bridgework. It is<br>intended for delayed<br>loading. Ultra wide<br>Implant system is<br>intended to be used in<br>the molar region.<br>Products with<br>diameter or less than<br>3.25mm should be<br>used exclusively for<br>the lateral incisor in<br>the maxilla and a<br>central or lateral<br>incisor in the<br>mandible. | The Osstem Implant<br>System is indicated<br>for use in partially or<br>fully edentulous<br>mandibles and<br>maxillae, in support<br>of single or multiple-<br>units restorations<br>including; cemented<br>retained, screw<br>retained, or<br>overdenture<br>restorations, and final<br>or temporary<br>abutment support for<br>fixed bridgework. It is<br>intended for delayed<br>loading. Ultra wide<br>Implant system is<br>intended to be used in<br>the molar region.<br>Products with<br>diameter or less than<br>3.25mm should be<br>used exclusively for<br>the lateral incisor in<br>the maxilla and a<br>central or lateral<br>incisor in the<br>mandible. | The Osstem Implant<br>System is indicated<br>for use in partially or<br>fully edentulous<br>mandibles and<br>maxillae, in support<br>of single or multiple-<br>units restorations<br>including; cemented<br>retained, screw<br>retained, or<br>overdenture<br>restorations, and final<br>or temporary<br>abutment support for<br>fixed bridgework.<br>Products with<br>diameter of less than<br>3.25mm should be<br>used exclusively for<br>the lateral incisor in<br>the maxilla and a<br>central or lateral<br>incisor in the<br>mandible. | Southern Implants'<br>External Hex<br>Implants are intended<br>for surgical placement<br>in the upper or lower<br>jaw to provide a<br>means for prosthetic<br>attachment of crowns,<br>bridges or<br>overdentures utilizing<br>delayed or immediate<br>loading.<br>Southern Implants'<br>External Hex<br>Implants are intended<br>for immediate<br>function when good<br>primary stability with<br>appropriate occlusal<br>loading is achieved. | Same |
| Diameter (D) | ø3.75 x L 18, 20 mm | ø4.6 x L 18 mm | ø3.75 x L 10, 11.5 | ø 3.25 x L 8.5, 10 | Different |
| and Length<br>(L) | ø3.77 x L 7 mm<br>ø4.25 x L 7 mm<br>ø4.65 x L 7 mm<br>ø5.45 x L 10, 11.5,<br>13, 15 mm<br>ø5.48 x L 8.5 mm<br>ø5.5 x L 7mm | ø5.05 x L 18 mm | 13, 15 mm<br>ø3.77 x L 8.5 mm<br>ø4.2 x L 10, 11.5, 13,<br>15, 18 mm<br>ø4.25 x L 7, 8.5 mm<br>ø4.6 x L 10, 11.5, 13,<br>15 mm<br>ø4.63 x L 8.5 mm<br>ø4.65 x L 7 mm<br>ø5.05 x L 10, 11.5,<br>13, 15 mm<br>ø5.08 x L 8.5 mm<br>ø5.1 x L 6.2, 7<br>mmø3.5 x L 8.5, 10,<br>11.5, 13, 15 mm<br>ø4.2 x L 7, 8.5, 10,<br>11.5, 13, 15 mm<br>ø4.4 x L 7, 8.5, 10,<br>11.5, 13, 15 mm<br>ø4.9 x L 7, 8.5, 10,<br>11.5, 13, 15 mm | 11.5, 13, 15, 18 mm<br>ø 3.75 x L 7, 8.5, 10,<br>11.5, 13, 15, 18, 20<br>mm<br>ø 4.0 x L 6, 8.5, 10,<br>11.5, 13, 15, 18, 20<br>mm<br>ø 4.7 x L 8.5, 10,<br>11.5, 13, 15, 18 mm<br>ø 5.0 x L 6, 7, 8.5,<br>11.5, 13, 15, 18 mm<br>ø 5.7 x L 10, 11.5, 13,<br>15, 18 mm<br>ø 6.0 x L 7, 8.5, 10,<br>11.5, 13, 15 mm | |
| Material | Titanium Grade 4<br>(ASTM F67) | Titanium Grade 4<br>(ASTM F67) | Titanium Grade 4<br>(ASTM F67) | CP Titanium | Same |
| Surface | SA | SA | SA | Grit blasted<br>Machine collar<br>versions available | Same |
| Connection | Internal Hex | Internal Hex | Internal Hex | External Hex | Same |
| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile | NA | Same |
| Shelf life | 8 years | 8 years | 8 years | NA | Same |
| | <b>Similarities</b><br>Proposed TSIII SA Implant has same design, function and indication for use; and is made with same<br>material with same manufacturing process (including surface treatment) by same manufacturer compared to<br>that of the predicate TSIII SA Implant, K161604 and K121995. | | | | |
| S.E. | <b>Differences</b><br>The proposed device has different range of dimensions than predicate device. However, the added diameter<br>is larger than predicate device, so it is more stable than predicate device. Although there is the additional of<br>extended implant lengths of 20mm, additional length is included in dimension range of predicate device,<br>K163634. In addition, since proposed device is compatible with the same abutment, it has same moment- | | | | |

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Image /page/7/Picture/1 description: The image shows the text 'K222778'. The text is in a simple, sans-serif font and is horizontally oriented. The text is black against a white background, providing high contrast and readability.

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: [phone] Fax: [phone] www.osstem.com

: . The proposed TSIII SA Implant is substantially equivalent to the predicate devices.

### 2) TSIII SA Implant (Non-Hex) Ø 3.2

arm as predicate devices, K161604 and K121995.

| | Subject Device | Predicate Device | Remark |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Device Name | TSIII SA Implant (Non-Hex) Ø 3.2 | TSIII SA Implant 3.2 | Different |
| 510(k) Number | - | K161604 | - |
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same |
| Design | Image: Implant | Image: Implant | Same |
| Indication for Use | The Osstem Implant System is indicated for<br>use in partially or fully edentulous<br>mandibles and maxillae, in support of<br>single or multiple-units restorations<br>including; cemented retained, screw<br>retained, or overdenture restorations, and<br>final or temporary abutment support for<br>fixed bridgework. It is intended for delayed<br>loading. Ultra wide Implant system is<br>intended to be used in the molar region.<br>Products with diameter or less than 3.25mm<br>should be used exclusively for the lateral<br>incisor in the maxilla and a central or lateral<br>incisor in the mandible. | The Osstem Implant System is indicated for<br>use in partially or fully edentulous<br>mandibles and maxillae, in support of<br>single or multiple-units restorations<br>including; cemented retained, screw<br>retained, or overdenture restorations, and<br>final or temporary abutment support for<br>fixed bridgework. It is intended for delayed<br>loading. Ultra wide Implant system is<br>intended to be used in the molar region.<br>Products with diameter or less than 3.25mm<br>should be used exclusively for the lateral<br>incisor in the maxilla and a central or lateral<br>incisor in the mandible. | Same |
| Diameter (D) and<br>Length (L) | $Ø$ 3.2 x L 8.5, 10.0, 11.5, 13.0, 15.0 mm | $Ø$ 3.2 x L 8.5, 10.0, 11.5, 13.0, 15.0 mm | Same |
| Connection | Non-Hex | Hex | Different |
| Material | Titanium Alloy (ASTM F136)…