(374 days)
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.
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.
Here's an analysis of the provided text to extract information about acceptance criteria and the supporting study:
The document is a 510(k) summary for the Osstem Implant System, seeking substantial equivalence to predicate devices. As such, it focuses on demonstrating that the new device modifications (primarily additional dimensions and a non-hex connection for some implants) are as safe and effective as the previously cleared predicate devices. Therefore, the "acceptance criteria" discussed are primarily about meeting existing performance standards (like ISO 14801 for fatigue testing) and demonstrating consistency with the predicate devices in terms of materials, manufacturing, indications for use, etc.
Since this is a substantial equivalence submission for a dental implant system involving physical product variations rather than a novel AI/software device, many of the typical AI-specific criteria (like MRMC studies, effect size of AI assistance, standalone algorithm performance, number of experts for ground truth, adjudication methods, training set size/ground truth establishment) are generally not applicable or explicitly stated in the context of this traditional medical device submission.
1. A table of acceptance criteria and the reported device performance
For the specific modifications in the proposed device, the primary acceptance criterion for mechanical performance is successful fatigue testing according to ISO 14801:2016 for the worst-case scenario. Other performance criteria are met by leveraging tests performed on predicate devices, demonstrating equivalence in materials, manufacturing, and design principles.
| Acceptance Criteria (Study Performed) | Reported Device Performance |
|---|---|
| Fatigue Testing (ISO 14801:2016) for worst-case implant-abutment combination (specifically for TSIII SA Implant (Non-Hex)) | Test results demonstrate that the proposed devices perform as intended and support substantial equivalence to the predicate devices. (No specific numerical values are given in this summary.) |
| Gamma Sterilization Validation (ISO 11137-1,2,3) (leveraged from K121585) | Met the standards. No change to manufacturing or sterilization processes. |
| Shelf-Life Testing (ASTM F1980) (leveraged from K121585) | Met the standards. |
| Biocompatibility Testing (ISO 10993-1, -6, -10, -11) (leveraged from K121995) | Met the standards. Subject device is biocompatible and substantially equivalent due to same materials and manufacturing. |
| Bacterial Endotoxin Test (ISO 10993-11, USP<151>) (leveraged from K161604) | Met the standards. |
| MR Compatibility Review (magnetic displacement force and torque evaluation per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment") | Non-clinical worst-case MRI review performed using scientific rationale and published literature for the entire system and material composition. Rationale addressed parameters per FDA guidance. (No specific results stated beyond review was performed.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Fatigue Testing (ISO 14801:2016): The document mentions "worst-case implant-abutment combination" was chosen. ISO 14801 typically specifies minimum sample sizes (e.g., 5 or 10 samples per test condition for static or dynamic testing). The exact number of samples tested for the new Non-Hex implants is not explicitly stated in this summary, nor is the provenance of the test data (e.g., conducted in-house, by a certified lab). However, such tests are generally conducted prospectively on newly manufactured devices or representative samples.
- Other tests (Sterilization, Shelf-Life, Biocompatibility, Bacterial Endotoxin): These were leveraged from predicate devices (K121585, K121995, K161604). The sample sizes and provenance for those original predicate device studies are not detailed in this submission.
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 for this type of device submission. This is a mechanical and material performance evaluation, not a diagnostic or interpretative device requiring clinical expert ground truth for a test set. Design requirements and performance standards (like ISO 14801) define the "ground truth" to be met.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this type of device submission. Adjudication methods are typically used in clinical or image-based studies to resolve discrepancies among experts.
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 a dental implant system, not a diagnostic or AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware medical device; there is no algorithm or AI component for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For mechanical performance (like fatigue testing), the "ground truth" is defined by international standards (ISO 14801:2016) and applicable FDA guidance documents. These standards specify test methods, failure criteria, and acceptable performance limits for dental implants.
- For material and biological compatibility, the "ground truth" is established by adherence to ISO 10993 standards for biocompatibility, ISO 11137 for sterilization, and ASTM F1980 for shelf-life. These are laboratory-based, objective performance measures.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set. The device design and materials are based on established engineering principles and prior predicate devices.
9. How the ground truth for the training set was established
- Not applicable.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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 -: +82-51-850-2500 -Phone : 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 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: +82 51 850 2500 Fax: +82 51 861 4693 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 mmø3.77 x L 7 mmø4.25 x L 7 mmø4.65 x L 7 mmø5.45 x L 10, 11.5, 13, 15 mmø5.48 x L 8.5 mmø5.5 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 mmø3.77 x L 8.5 mmø3.8 x L 8.5, 10, 11.5, 13, 15, 18 mmø4.2 x L 10, 11.5, 13, 15, 18 mmø4.25 x L 7, 8.5 mm04.6 x L 10, 11.5, 13, 15, 18 mmø4.63 x L 8.5 mmø4.65 x L 7 mm05.05 x L 10, 11.5, 13, 15, 18 mm05.08 x L 8.5 mmø5.1 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 mm04 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: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
| TS Scan Healing Abutment | Description | Ø5.25 x L 18 mmIt is used to make a natural soft tissue shape beforesetting up prosthetics and removing cover screw afterosseointegration. | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Material | Titanium Grade 4 (ASTM F67) | ||||||||||||||||
| Diameter (D) andLength (L) | Ø4.3 x L 5.5, 5.6, 6.5, 6.6, 7.5, 7.6, 9.5, 9.6, 11.6 mmØ4.8 x L 5.5, 5.6, 6.5, 6.6, 7.5, 7.6, 9.5, 9.6, 11.5 mmØ5.3 x L 5.5, 6.5, 7.5, 9.5, 11.5 mmØ6.3 x L 5.5, 6.5, 7.5, 9.5, 11.5 mmØ7.3 x L 5.5, 6.5, 7.5, 9.5 mm | ||||||||||||||||
| TS Scan Healing AbutmentScrew | Description | It is used to make a natural soft tissue shape beforesetting up prosthetics and removing cover screw afterosseointegration. | |||||||||||||||
| Material | Titanium Alloy (ASTM F136) | ||||||||||||||||
| Diameter (D) andLength (L) | Ø2.2 x L 10, 11, 12, 14, 16 mmØ2.3 x L 8, 9, 10, 12, 14 mm | ||||||||||||||||
| SSII SA Implant | Description | Intended to be surgically placed in the bone of theupper 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 theupper 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 theupper 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: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
| 1) TSIII SA Implant | |||||
|---|---|---|---|---|---|
| Subject device | Primary predicatedevice | Predicate device | Reference device | Remark | |
| Device Name | TSIII SA Implant | TSIII SA Implant | TSIII SA Implant | External HexImplants | Same |
| 510(k)Number | - | K161604 | K121995 | K163634 | - |
| Manufacturer | Osstem Implant Co.,Ltd | Osstem Implant Co.,Ltd | Osstem Implant Co.,Ltd | NA | Same |
| Design | Image: Implant design | Image: Implant design | Image: Implant design | NA | Similar |
| Indication forUse | The Osstem ImplantSystem is indicatedfor use in partially orfully edentulousmandibles andmaxillae, in supportof single or multiple-units restorationsincluding; cementedretained, screwretained, oroverdenturerestorations, and finalor temporaryabutment support forfixed bridgework. It isintended for delayedloading. Ultra wideImplant system isintended to be used inthe molar region.Products withdiameter or less than3.25mm should beused exclusively forthe lateral incisor inthe maxilla and acentral or lateralincisor in themandible. | The Osstem ImplantSystem is indicatedfor use in partially orfully edentulousmandibles andmaxillae, in supportof single or multiple-units restorationsincluding; cementedretained, screwretained, oroverdenturerestorations, and finalor temporaryabutment support forfixed bridgework. It isintended for delayedloading. Ultra wideImplant system isintended to be used inthe molar region.Products withdiameter or less than3.25mm should beused exclusively forthe lateral incisor inthe maxilla and acentral or lateralincisor in themandible. | The Osstem ImplantSystem is indicatedfor use in partially orfully edentulousmandibles andmaxillae, in supportof single or multiple-units restorationsincluding; cementedretained, screwretained, oroverdenturerestorations, and finalor temporaryabutment support forfixed bridgework.Products withdiameter of less than3.25mm should beused exclusively forthe lateral incisor inthe maxilla and acentral or lateralincisor in themandible. | Southern Implants'External HexImplants are intendedfor surgical placementin the upper or lowerjaw to provide ameans for prostheticattachment of crowns,bridges oroverdentures utilizingdelayed or immediateloading.Southern Implants'External HexImplants are intendedfor immediatefunction when goodprimary stability withappropriate occlusalloading 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(L) | ø3.77 x L 7 mmø4.25 x L 7 mmø4.65 x L 7 mmø5.45 x L 10, 11.5,13, 15 mmø5.48 x L 8.5 mmø5.5 x L 7mm | ø5.05 x L 18 mm | 13, 15 mmø3.77 x L 8.5 mmø4.2 x L 10, 11.5, 13,15, 18 mmø4.25 x L 7, 8.5 mmø4.6 x L 10, 11.5, 13,15 mmø4.63 x L 8.5 mmø4.65 x L 7 mmø5.05 x L 10, 11.5,13, 15 mmø5.08 x L 8.5 mmø5.1 x L 6.2, 7mmø3.5 x L 8.5, 10,11.5, 13, 15 mmø4.2 x L 7, 8.5, 10,11.5, 13, 15 mmø4.4 x L 7, 8.5, 10,11.5, 13, 15 mmø4.9 x L 7, 8.5, 10,11.5, 13, 15 mm | 11.5, 13, 15, 18 mmø 3.75 x L 7, 8.5, 10,11.5, 13, 15, 18, 20mmø 4.0 x L 6, 8.5, 10,11.5, 13, 15, 18, 20mmø 4.7 x L 8.5, 10,11.5, 13, 15, 18 mmø 5.0 x L 6, 7, 8.5,11.5, 13, 15, 18 mmø 5.7 x L 10, 11.5, 13,15, 18 mmø 6.0 x L 7, 8.5, 10,11.5, 13, 15 mm | |
| Material | Titanium Grade 4(ASTM F67) | Titanium Grade 4(ASTM F67) | Titanium Grade 4(ASTM F67) | CP Titanium | Same |
| Surface | SA | SA | SA | Grit blastedMachine collarversions 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 |
| SimilaritiesProposed TSIII SA Implant has same design, function and indication for use; and is made with samematerial with same manufacturing process (including surface treatment) by same manufacturer compared tothat of the predicate TSIII SA Implant, K161604 and K121995. | |||||
| S.E. | DifferencesThe proposed device has different range of dimensions than predicate device. However, the added diameteris larger than predicate device, so it is more stable than predicate device. Although there is the additional ofextended implant lengths of 20mm, additional length is included in dimension range of predicate device,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: +82 51 850 2500 Fax: +82 51 861 4693 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 foruse 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 for delayedloading. Ultra wide Implant system isintended to be used in the molar region.Products with diameter or less than 3.25mmshould be used exclusively for the lateralincisor in the maxilla and a central or lateralincisor in the mandible. | The Osstem Implant System is indicated foruse 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 for delayedloading. Ultra wide Implant system isintended to be used in the molar region.Products with diameter or less than 3.25mmshould be used exclusively for the lateralincisor in the maxilla and a central or lateralincisor in the mandible. | Same |
| Diameter (D) andLength (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) | Titanium Alloy (ASTM F136) | Same |
| Surface | SA | SA | Same |
| Sterilization | Radiation Sterile | Radiation Sterile | Same |
| Shelf life | 8 years | 8 years | Same |
| S.E. | SimilaritiesProposed TSIII SA Implant (Non-Hex) $Ø$ 3.2 has same design, function and indication for use; and ismade with same material with same manufacturing process (including surface treatment) by samemanufacturer compared to that of the predicate TSIII SA Implant 3.2 (K161604).DifferencesThe proposed TSIII SA Implant (Non-Hex) $Ø$ 3.2 is included in dimension range of predicate deviceand has the same diameter of the embedding plane according to the ISO14801. However, proposedTSIII SA Implant (Non-Hex) $Ø$ 3.2 has non hexagon connection that is different from predicate TSIIISA Implant. Therefore, we conducted fatigue test according to ISO14801 and the test result does notshow any significant difference in regard of mechanical strength.: · Proposed TSIII SA Implant (Non-Hex) $Ø$ 3.2 and the predicate TSIII SA Implant 3.2 havecommon in design, function, indications for use, material, manufacturing process, manufacturer, etc .;therefore, the proposed TSIII SA Implant (Non-Hex) $Ø$ 3.2 is substantially equivalent to the predicatedevice. |
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Image /page/8/Picture/2 description: The image shows the logo for Osstem Implant. The logo is in orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. There is a superscript "6" after the word "OSSTEM".
OSSTEM Implant Co., Ltd.
{9}------------------------------------------------
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
3) TSIII SA Implant (Non-Hex)
| Subject device | Primary predicate device | Predicate device | Remark | |
|---|---|---|---|---|
| Device Name | TSIII SA Implant(Non-Hex) | TSIII SA Implant | TSIII SA Implant | Same |
| 510(k) Number | K161604 | K121995 | - | |
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same |
| Design | Image: TSIII SA Implant (Non-Hex) | Image: TSIII SA Implant | Image: TSIII SA Implant | Similar |
| Indication for Use | The Osstem Implant Systemis indicated for use inpartially or fully edentulousmandibles and maxillae, insupport of single ormultiple-units restorationsincluding; cementedretained, screw retained, oroverdenture restorations,and final or temporaryabutment support for fixedbridgework. It is intendedfor delayed loading. Ultrawide Implant system isintended to be used in themolar region.Products with diameter orless than 3.25mm should beused exclusively for thelateral incisor in the maxillaand a central or lateralincisor in the mandible. | The Osstem Implant Systemis indicated for use inpartially or fully edentulousmandibles and maxillae, insupport of single ormultiple-units restorationsincluding; cementedretained, screw retained, oroverdenture restorations,and final or temporaryabutment support for fixedbridgework. It is intendedfor delayed loading. Ultrawide Implant system isintended to be used in themolar region.Products with diameter orless than 3.25mm should beused exclusively for thelateral incisor in the maxillaand a central or lateralincisor in the mandible. | The Osstem Implant Systemis indicated for use inpartially or fully edentulousmandibles and maxillae, insupport of single ormultiple-units restorationsincluding; cementedretained, screw retained, oroverdenture restorations,and final or temporaryabutment support for fixedbridgework.Products with diameter ofless than 3.25mm should beused exclusively for thelateral incisor in the maxillaand a central or lateralincisor in the mandible. | Same |
| Diameter (D) andLength (L) | ø3.75 x L 10, 11.5, 13 mmø3.77 x L 8.5 mmø3.8 x L 8.5, 10, 11.5, 13,15, 18 mmø4.2 x L 10, 11.5, 13, 15, 18mmø4.25 x L 7, 8.5 mmø4.6 x L 10, 11.5, 13, 15, 18mmø4.63 x L 8.5 mm | ø4.6 x L 18 mmø5.05 x L 18 mm | ø3.75 x L 10, 11.5, 13, 15mmø3.77 x L 8.5 mmø4.2 x L 10, 11.5, 13, 15, 18mmø4.25 x L 7, 8.5 mmø4.6 x L 10, 11.5, 13, 15mmø4.63 x L 8.5 mmø4.65 x L 7 mm | Different |
| ø4.65 x L 7 mmø5.05 x L 10, 11.5, 13, 15,18 mmø5.08 x L 8.5 mmø5.1 x L 7 mm | ø5.05 x L 10, 11.5, 13, 15 mmø5.08 x L 8.5 mmø5.1 x L 6.2, 7 mmø3.5 x L8.5, 10, 11.5, 13, 15 mmø4.2 x L 7, 8.5, 10, 11.5, 13,15 mmø4.4 x L 7, 8.5, 10, 11.5, 13,15 mmø4.9 x L 7, 8.5, 10, 11.5, 13,15 mm | |||
| Material | Titanium Grade 4(ASTM F67) | Titanium Grade 4(ASTM F67) | Same | |
| Surface | SA | SA | Same | |
| Connection | Internal Non-Hex | Internal Hex | Different | |
| Sterilization | Radiation Sterile | Radiation Sterile | Same | |
| Shelf life | 8 years | 8 years | Same | |
| S.E. | SimilaritiesProposed TSIII SA Implant (Non-Hex) has same design, function and indication for use; and is madewith same material with same manufacturing process (including surface treatment) by samemanufacturer compared to that of the predicate TSIII SA Implant, K161604 and K121995.DifferencesThe proposed TSIII SA Implant (Non-Hex) is included in dimension range of predicate device.Proposed TSIII SA Implant (Non-Hex) has non hexagon connection that is different from predicateTSIII SA Implant, but has the same diameter of the embedding plane as predicate device according tothe ISO14801. Therefore, we selected the proposed device with the smallest diameter as the worstcase and conducted fatigue test according to ISO14801, and the test result does not show anysignificant difference in regard of mechanical strength.Proposed TSIII SA Implant (Non-Hex) and the predicate TSIII SA Implant have common indesign, function, indications for use, material, manufacturing process, manufacturer, etc.; therefore,the proposed TSIII SA Implant (Non-Hex) is substantially equivalent to the predicate device. |
{10}------------------------------------------------
Image /page/10/Picture/1 description: The image shows the text 'K222778'. The text is in a simple sans-serif font. The text is black and the background is white. The text appears to be a code or identifier.
Image /page/10/Picture/2 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. There is a superscript "6" next to 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
4) TSIV SA Implant
| Subject Device | Predicate Device | Reference device | Remark | |
|---|---|---|---|---|
| Device Name | TSIV SA Implant | TSIV SA Implant | External Hex Implants | Same |
| 510(k) Number | - | K161604 | K163634 | - |
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | NA | Same |
| Design | Image: Implant | Image: Implant | NA | Same |
| Indication for Use | The Osstem Implant Systemis indicated for use inpartially or fully edentulousmandibles and maxillae, insupport of single ormultiple-units restorationsincluding; cementedretained, screw retained, oroverdenture restorations,and final or temporaryabutment support for fixedbridgework. It is intendedfor delayed loading. Ultrawide Implant system isintended to be used in themolar region.Products with diameter orless than 3.25mm should beused exclusively for thelateral incisor in the maxillaand a central or lateralincisor in the mandible. | The Osstem Implant Systemis indicated for use inpartially or fully edentulousmandibles and maxillae, insupport of single ormultiple-units restorationsincluding; cementedretained, screw retained, oroverdenture restorations,and final or temporaryabutment support for fixedbridgework. It is intendedfor delayed loading. Ultrawide Implant system isintended to be used in themolar region.Products with diameter orless than 3.25mm should beused exclusively for thelateral incisor in the maxillaand a central or lateralincisor in the mandible. | Southern Implants' ExternalHex Implants are intendedfor surgical placement in theupper or lower jaw toprovide a means forprosthetic attachment ofcrowns, bridges oroverdentures utilizingdelayed or immediateloading.Southern Implants' ExternalHex Implants are intendedfor immediate functionwhen good primary stabilitywith appropriate occlusalloading is achieved. | Same |
| Diameter (D) andLength (L) | Ø4.4 x L 18 mmØ4.8 x L 18 mmØ5.25 x L 18 mm | Ø4.4 x L 7, 8.5, 10, 11.5, 13,15 mmØ4.8 x L 7, 8.5, 10, 11.5, 13,15 mmØ5.25 x L 7, 8.5, 10, 11.5,13, 15 mm | Ø 3.25 x L 8.5, 10, 11.5, 13,15, 18 mmØ 3.75 x L 7, 8.5, 10, 11.5,13, 15, 18, 20 mmØ 4.0 x L 6, 8.5, 10, 11.5,13, 15, 18, 20 mmØ 4.7 x L 8.5, 10, 11.5, 13,15, 18 mmØ 5.0 x L 6, 7, 8.5, 11.5, 13,15, 18 mmØ 5.7 x L 10, 11.5, 13, 15,18 mmØ 6.0 x L 7, 8.5, 10, 11.5,13, 15 mm | Different |
| Material | Titanium Grade 4 (ASTMF67) | Titanium Grade 4 (ASTMF67) | CP Titanium | Same |
| Surface | SA | SA | Grit blastedMachine collar versions | Same |
| available | ||||
| External Hex | ||||
| Sterilization | Radiation Sterile | Radiation Sterile | NA | Same |
| Shelf life | 8 years | 8 years | NA | Same |
| S.E. | SimilaritiesProposed TSIV SA Implant has same design, function and indication for use; and is made with samematerial with same manufacturing process (including surface treatment) by same manufacturercompared to that of the predicate TSIV SA Implant (K161604).DifferencesThere is the additional of extended implant lengths of 18mm, but additional length is included indimension range of predicate device. In addition, since proposed device is compatible with the sameabutment as predicate device, there is no difference in moment-arm, so the difference in length is nota factor affecting performance. Therefore, we didn't consider additional fatigue test according toISO14801..: Proposed TSIV SA Implant and the predicate TSIV SA Implant have common in design, function,indications for use, material, manufacturing process, manufacturer, etc.; therefore, the proposed TSIVSA Implant is substantially equivalent to the predicate device. |
{11}------------------------------------------------
Image /page/11/Picture/2 description: The image shows the logo for Osstem Implant. The logo is in orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. There is a superscript "6" next to the word "OSSTEM".
{12}------------------------------------------------
Image /page/12/Picture/1 description: The image shows the alphanumeric string "K222778" in a simple, sans-serif font. The characters are arranged horizontally, with consistent spacing between them. The text is black against a white background, providing high contrast and readability.
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
5) TS Scan Healing Abutment
| Subject Device | Predicate Device | Remark | |
|---|---|---|---|
| Device Name | TS Scan Healing Abutment | Healing Abutment | Different |
| 510(k) Number | - | K161604 | - |
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same |
| Design | Image: Subject Device Design | Image: Predicate Device Design | Similar |
| Description | Used to make a natural soft tissue shapeuntil setting up prosthetics.It is intended use to combine withimplanted fixture after osseointegrationthen removing cover screw. | Used to make a natural soft tissue shapeuntil setting up prosthetics.It is intended use to combine withimplanted fixture after osseointegrationthen removing cover screw. | Same |
| Diameter (D) andLength (L) | ø4.3 x L 5.5, 5.6, 6.5, 6.6, 7.5, 7.6, 9.5, 9.6,11.6 mmø4.8 x L 5.5, 5.6, 6.5, 6.6, 7.5, 7.6, 9.5, 9.6,11.5 mmø5.3 x L 5.5, 6.5, 7.5, 9.5, 11.5 mmø6.3 x L 5.5, 6.5, 7.5, 9.5, 11.5 mmø7.3 x L 5.5, 6.5, 7.5, 9.5 mm | ø4.3 x L 7.5, 8.5, 9.5, 10.5, 11.5, 12.5, 13.5,14.5 mmø4.8 x L 7.5, 8.5, 9.5, 10.5, 11.5, 12.5, 13.5,14.5 mmø5.3 x L 8.5, 9.5, 10.5, 12.5, 14.5 mmø6.3 x L 8.5, 9.5, 10.5, 12.5, 14.5 mmø7.3 x L 8.5, 9.5, 10.5, 12.5, 14.5 mm | Different |
{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, italicized font. A superscript "6" is located 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
| ScrewØ2.2 x L 10, 11, 12, 14, 16 mmØ2.3 x L 8, 9, 10, 12, 14 mm | Ø8.3 x L 10.5 mm | ||
|---|---|---|---|
| Material | Titanium Grade 4(ASTMF67)* Screw: Titanium Alloy (ASTM F136) | Titanium Grade 4(ASTMF67) | Different |
| Sterilization | Radiation Sterile | Radiation Sterile | Same |
| Shelf life | 8 years | 8 years | Same |
| S.E. | SimilaritiesProposed TS Scan Healing Abutment has same function and indication for use; and is made withsame material with same manufacturing process by same manufacturer compared to that of thepredicate Healing Abutment (K161604).DifferencesThere is difference between proposed device and predicate on design. The predicate device has ascrew-combined design compared to the proposed device. In addition, since TS Scan HealingAbutment is used temporarily to make natural soft tissue shape until setting up prosthetics, it does notrequire any performance. Therefore, we didn't consider additional performance testing.: . Proposed TS Scan Healing Abutment and the predicate Healing Abutment have common infunction, indications for use, material, manufacturing process, manufacturer, etc.; therefore, theproposed TS Scan Healing Abutment is substantially equivalent to the predicate device |
6) SSII SA Implant
| Subject Device | Predicate Device | Reference Device | Remark | |
|---|---|---|---|---|
| Device Name | SSII SA Implant | SSII SA Implant | External Hex Implants | Same |
| 510(k) Number | - | K163557 | K163634 | - |
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | NA | Same |
| Design | Image: Dental Implant | Image: Dental Implant | NA | Similar |
| Indication forUse | The Osstem Implant Systemis indicated for use inpartially or fully edentulousmandibles and maxillae, insupport of single or multiple-units restorations including;cemented retained, screwretained, or overdenture | The Osstem Implant isindicated for use in partiallyor fully edentulousmandibles and maxillae, insupport of single or multiple-unit restorations including;cemented retained, screwretained, or overdenture | Southern Implants' ExternalHex Implants are intendedfor surgical placement in theupper or lower jaw toprovide a means forprosthetic attachment ofcrowns, bridges oroverdentures utilizing | Same |
| restorations, and final ortemporary abutment supportfor fixed bridgework. It isintended for delayed loading.Ultra wide Implant system isintended to be used in themolar region.Products with diameter orless than 3.25mm should beused exclusively for thelateral incisor in the maxillaand a central or lateralincisor in the mandible. | restorations, and finally ortemporary abutment supportfor fixed bridgework. It isintended for delayed loading.Ultra Wide Implant Systemis intended to be used in themolar region. | delayed or immediateloading.Southern Implants' ExternalHex Implants are intendedfor immediate function whengood primary stability withappropriate occlusal loadingis achieved. | ||
| Appearance | Image: Implant | Image: Implant | NA | Different |
| Dimension | ø 4.8 x L 7, 8.5, 10, 11.5, 13,15 mmø 6.0 x L 7, 8.5, 10, 11.5, 13,15 mm | ø 4.1 x L 7, 8.5, 10, 11.5, 13,15 mmø 4.45 x L 7, 8.5, 10, 11.5,13, 15 mmø 4.9 x L 7, 8.5, 10, 11.5, 13,15 mmø 5.0 x L 6 mm | ø 3.25 x L 8.5, 10, 11.5, 13,15, 18 mmø 3.75 x L 7, 8.5, 10, 11.5,13, 15, 18, 20 mmø 4.0 x L 6, 8.5, 10, 11.5, 13,15, 18, 20 mmø 4.7 x L 8.5, 10, 11.5, 13,15, 18 mmø 5.0 x L 6, 7, 8.5, 11.5, 13,15, 18 mmø 5.7 x L 10, 11.5, 13, 15, 18mmø 6.0 x L 7, 8.5, 10, 11.5, 13,15 mm | Different |
| Material | Titanium Grade 4 (ASTMF67) | Titanium Grade 4 (ASTMF67) | CP Titanium | Same |
| Surface | SA | SA | Grit blastedMachine collar versionsavailable | Same |
| Connection | Internal Octa | Internal Octa | External Hex | Different |
| Sterilization | Radiation Sterile | Radiation Sterile | NA | Same |
| Shelf life | 8 years | 8 years | NA | Same |
| S.E. | SimilaritiesProposed SSII SA Implant has same design, function and indication for use; and is made with samematerial with same manufacturing process (including surface treatment) by same manufacturer comparedto that of the predicate SSII SA Implant (K163557).DifferencesIn addition, since proposed device is compatible with the same abutment and has same moment arm as |
{14}------------------------------------------------
Image /page/14/Picture/1 description: The image shows the text 'K222778'. The text is in a simple, sans-serif font and is presented in black against a white background. The text appears to be a code or identifier.
OSSTEM®
OSSTEM Implant Co., Ltd.
{15}------------------------------------------------
Image /page/15/Picture/1 description: The image shows the text "K222778" in a simple, sans-serif font. The text is black against a white background. The letters and numbers are evenly spaced and clearly legible.
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
| predicate device, K163557. | |
|---|---|
| Proposed devices with the same combination of dimensions, except for gingival height only, are identicalin all implanted parts. In addition, since the diameter of embedding plane is same as predicate device, wedidn't consider additional fatigue test according to ISO14801. | |
| ∴ Therefore, the proposed SSII SA Implant is substantially equivalent to the predicate devices. |
Subject Device Predicate Device Reference Device Remark SSIII SA Implant Device Name SSIII SA Implant External Hex Implants Same 510(k) Number K163557 K163634 -1 Osstem Implant Co., Ltd Osstem Implant Co., Ltd NA Manufacturer Same Design NA Similar The Osstem Implant System The Osstem Implant is Southern Implants' External is indicated for use in indicated for use in partially Hex Implants are intended for partially or fully edentulous or fully edentulous mandibles surgical placement in the mandibles and maxillae, in and maxillae, in support of upper or lower jaw to provide support of single or multiplesingle or multiple-unit a means for prosthetic units restorations including; restorations including: attachment of crowns, cemented retained, screw cemented retained, screw bridges or overdentures retained, or overdenture retained, or overdenture utilizing delayed or restorations, and final or restorations, and finally or immediate loading. temporary abutment support temporary abutment support Southern Implants' External Indication for for fixed bridgework. It is for fixed bridgework. It is Hex Implants are intended for Same Use intended for delayed loading. intended for delayed loading. immediate function when Ultra wide Implant system is Ultra Wide Implant System is good primary stability with intended to be used in the intended to be used in the appropriate occlusal loading molar region. molar region. is achieved. Products with diameter or less than 3.25mm should be used exclusively for the lateral incisor in the maxilla and a central or lateral incisor in the mandible.
7) SSIII SA Implant
{16}------------------------------------------------
Image /page/16/Picture/2 description: The image contains the logo for the company Osstem Implant. The logo is comprised of the word "OSSTEM" in orange, with a superscript "6" next to it. Below the word "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and modern.
| Appearance | Image: dental implant | Image: dental implant | NA | Different |
|---|---|---|---|---|
| Dimension | ø 4.8 x L 7, 8.5, 10, 11.5, 13, 15 mmø 60 x L 7, 8.5, 10, 11.5, 13, 15 mm | ø 3.75 x L 8.5, 10, 11.5, 13 mmø 4.25 x L 7, 8.5, 10, 11.5, 13 mmø 4.6 x L 7, 8.5, 10, 11.5, 13 mmø 5.0 x L 10, 11.5, 13 mmø 5.05 x L 6, 7, 8.5 mm | ø 3.25 x L 8.5, 10, 11.5, 13, 15, 18 mmø 3.75 x L 7, 8.5, 10, 11.5, 13, 15, 18, 20 mmø 4.0 x L 6, 8.5, 10, 11.5, 13, 15, 18, 20 mmø 4.7 x L 8.5, 10, 11.5, 13, 15, 18 mmø 5.0 x L 6, 7, 8.5, 11.5, 13, 15, 18 mmø 5.7 x L 10, 11.5, 13, 15, 18 mmø 6.0 x L 7, 8.5, 10, 11.5, 13, 15 mm | Different |
| Material | Titanium Grade 4 (ASTM F67) | Titanium Grade 4 (ASTM F67) | CP Titanium | Same |
| Surface | SA | SA | Grit blastedMachine collar versions available | Same |
| Connection | Internal Octa | Internal Octa | External Hex | Same |
| Sterilization | Radiation Sterile | Radiation Sterile | NA | Same |
| Shelf life | 8 years | 8 years | NA | Same |
| S.E. | SimilaritiesProposed SSIII SA Implant has same design, function and indication for use; and is made with same material with same manufacturing process (including surface treatment) by same manufacturer compared to that of the predicate SSIII SA Implant (K163557).DifferencesThere is the additional of extended implant lengths of 15mm, but additional length is included in dimension range of predicate device. In addition, since proposed device is compatible with the same abutment as predicate device, there is no difference in moment-arm, so the difference in length is not a factor affecting performance. Therefore, we didn't consider additional fatigue test according to ISO14801. Gingival height of the proposed device is smaller than predicate device, but the performance is not affected because it is a non-implantable part.Proposed device has a smaller surface area due to the difference in neck shape, but has a larger surface area compared to the predicate device SS2R4007S18, which has diameter Ø4.8 and length 7mm. In addition, since the diameter of embedding plane is same as predicate device, we didn't consider additional fatigue test according to ISO14801. |
{17}------------------------------------------------
Image /page/17/Picture/2 description: The image shows the logo and address of OSSTEM Implant Co., Ltd. The logo is in bold, with the letters "OSSTEM" being the largest. The address is located below the logo and includes the street number, street name, district, city, and country. The address is "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 SSIII SA Implant and the predicate SSIII SA Implant have common in design, function, indications for use, material, manufacturing process, manufacturer, etc.; therefore, the proposed SSIII SA Implant is substantially equivalent to the predicate device.
| 8) SSIII SA Ultra-Wide Implant | |||
|---|---|---|---|
| Subject Device | Predicate Device | Remark | |
| Device Name | SSIII SA Ultra-Wide Implant | SSIII SA Ultra-Wide Implant | Same |
| 510(k) Number | - | K163557 | - |
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same |
| Design | Image: Subject Device | Image: Predicate Device | Same |
| Indication forUse | The Osstem Implant System is indicated foruse in partially or fully edentulous mandiblesand maxillae, in support of single or multiple-units restorations including; cementedretained, screw retained, or overdenturerestorations, and final or temporary abutmentsupport for fixed bridgework. It is intendedfor delayed loading. Ultra wide Implantsystem is intended to be used in the molarregion.Products with diameter or less than 3.25mmshould be used exclusively for the lateralincisor in the maxilla and a central or lateralincisor in the mandible. | The Osstem Implant is indicated for use inpartially or fully edentulous mandibles andmaxillae, in support of single or multiple-unitrestorations including; cemented retained,screw retained, or overdenture restorations,and finally or temporary abutment support forfixed bridgework. It is intended for delayedloading. Ultra Wide Implant System isintended to be used in the molar region. | Same |
| Dimension | Ø 6.0 x L 7, 8.5, 10, 11.5, 13 mm | Ø 5.92 x L 11.5, 13 mmØ 5.95 x L 10 mmØ 5.96 x L 6, 8.5 mmØ 6.0 x L 7 mmØ 6.8 x L 7, 8.5, 10, 11.5, 13 mmØ 6.93 x L 6 mm | Different |
| Material | Titanium Grade 4 (ASTM F67) | Titanium Grade 4 (ASTM F67) | Same |
| Surface | SA | SA | Same |
| Connection | Internal Octa | Internal Octa | Same |
| Sterilization | Radiation Sterile | Radiation Sterile | Same |
| Shelf life | 8 years | 8 years | Same |
8) SSIII SA Ultra-Wide Implant
{18}------------------------------------------------
Image /page/18/Picture/2 description: The image contains the logo for OSSTEM IMPLANT. The logo is in orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray and is located below 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
| Similarities | |
|---|---|
| S.E. | Proposed SSIII SA Ultra-Wide Implant has same design, function and indication for use; and is made with same material with same manufacturing process (including surface treatment) by same manufacturer compared to that of the predicate SSIII SA Ultra-Wide Implant (K163557). |
| Differences | |
| Gingival height of the proposed device is different from predicate device SSIII SA Ultra-Wide Implant (K163557), but the performance is not affected because it is a non-implantable part. In addition, since the diameter of embedding plane is same as predicate device, we didn't consider additional fatigue test according to ISO14801. | |
| ∴ Proposed SSIII SA Ultra-Wide Implant and the predicate SSIII SA Ultra-Wide Implant have common in design, function, indications for use, material, manufacturing process, manufacturer, etc.; therefore, the proposed SSIII SA Ultra-Wide Implant is substantially equivalent to the predicate SSIII SA Ultra-Wide Implant (K163557). |
7. Summary of Non-clinical Performance Testing.
Below tests were performed on subject device:
-
Fatigue Testing under the worst-case scenario according to ISO 14801:2016
Below tests were performed for predicate devices and leveraged for the subject device: -
Gamma Sterilization Validation Test on Implants according to ISO 11137-1,2,3 referenced in K121585
-
. Shelf-Life Test on Implants according to ASTM F1980 referenced in K121585
-
. Biocompatibility testing according to ISO 10993-1:2009, ISO 10993-6:2007, ISO 10993-10:2006, ISO 10993-11:2006 referenced in K121995
-
. Bacterial Endotoxin Test Report on implants according to ISO 10993-11:2006 and USP<151> referenced in K161604
The results of the above tests have met the standards and demonstrated the substantial equivalence with the predicate device.
Validation of the gamma irradiation process was previously conducted for the predicate device, K121585. There has been no change to the manufacturing or sterilization processes.
The Biocompatibility Test was conducted on the predicate device and leveraged for the subject device because both products are manufactured with same materials, manufacturing process etc. It demonstrates that the subject device is biocompatible and substantial equivalence with the predicate.
The non-clinical testing result demonstrate that the subject device is substantially equivalent to the predicate device.
Osstem Implant System has SA (Sand blasted and Acid etched surface treatment that is exactly same with the predicate devices, K121585. There has been no change to the manufacturing or surface treatment processes.
Fatigue testing was considered according to the FDA Guidance for Industry and FDA Staff Class II Special Controls Guidance Document Root-form Endosseous Dental Inplants and Endosseous Dental Abutment and ISO 14801 standard with the worst case scenario.
For proposed TSIII SA Implant (Non-Hex), fatigue testing was conducted according to ISO 14801:2016 Dental-implants Dynamic Fatigue Test for Endosseous Dental Implants. The worst-case implant-abutment combination of the proposed device was chosen based on the FDA Guidance, ClassII Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. Test results demonstrate that the proposed devices perform as
{19}------------------------------------------------
Image /page/19/Picture/2 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 telephone number is +82 51 850 2500, the fax number is +82 51 861 4693, and the website address is www.osstem.com.
intended and support substantial equivalence to the predicate devices.
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 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.
Summary of Clinical Testing 8.
No clinical studies are submitted.
9. 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 Osstem is substantially equivalent to the predicate devices as herein.
§ 872.3640 Endosseous dental implant.
(a)
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.(b)
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.