(374 days)
No
The summary describes a dental implant system made of titanium and focuses on its mechanical properties, biocompatibility, and sterilization. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
No
The device is described as a dental implant system used to support restorations in partially or fully edentulous mandibles and maxillae, which falls under the category of a prosthetic or restorative device rather than one that directly treats a disease or condition.
No
The device description clearly states it is a "dental implant made of titanium metal intended to be surgically placed in the bone," indicating it is a prosthetic or restorative device, not one used for diagnosis.
No
The device description explicitly states it is a dental implant made of titanium metal, which is a physical hardware component. The performance studies also focus on physical properties like fatigue, sterilization, and biocompatibility.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgically implanted device used to support dental restorations in the jawbone. This is a direct medical intervention, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description confirms it's a dental implant made of titanium, surgically placed in the bone.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information. The device's function is mechanical support for dental prosthetics.
Therefore, the Osstem Implant System falls under the category of a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibles and maxillae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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 intended and support substantial equivalence to the predicate devices.
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.
No clinical studies are submitted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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
1
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
2
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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3
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.
4
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 mm | |
| ø3.77 x L 7 mm | ||
| ø4.25 x L 7 mm | ||
| ø4.65 x L 7 mm | ||
| ø5.45 x L 10, 11.5, 13, 15 mm | ||
| ø5.48 x L 8.5 mm | ||
| 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 | |
| ø3.77 x L 8.5 mm | ||
| ø3.8 x L 8.5, 10, 11.5, 13, 15, 18 mm | ||
| ø4.2 x L 10, 11.5, 13, 15, 18 mm | ||
| ø4.25 x L 7, 8.5 mm | ||
| 04.6 x L 10, 11.5, 13, 15, 18 mm | ||
| ø4.63 x L 8.5 mm | ||
| ø4.65 x L 7 mm | ||
| 05.05 x L 10, 11.5, 13, 15, 18 mm | ||
| 05.08 x L 8.5 mm | ||
| 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 | |
| 04 8 x L. 18 mm |
The specifications of the proposed device are as follow;
5
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 mm
It is used to make a natural soft tissue shape before
setting up prosthetics and removing cover screw after
osseointegration. | | | | | | | | | | | | | | | |
|-----------------------------------|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| | Material | Titanium Grade 4 (ASTM F67) | | | | | | | | | | | | | | | |
| | Diameter (D) and
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
Ø4.8 x L 5.5, 5.6, 6.5, 6.6, 7.5, 7.6, 9.5, 9.6, 11.5 mm
Ø5.3 x L 5.5, 6.5, 7.5, 9.5, 11.5 mm
Ø6.3 x L 5.5, 6.5, 7.5, 9.5, 11.5 mm
Ø7.3 x L 5.5, 6.5, 7.5, 9.5 mm | | | | | | | | | | | | | | | |
| TS Scan Healing Abutment
Screw | Description | It is used to make a natural soft tissue shape before
setting up prosthetics and removing cover screw after
osseointegration. | | | | | | | | | | | | | | | |
| | Material | Titanium Alloy (ASTM F136) | | | | | | | | | | | | | | | |
| | Diameter (D) and
Length (L) | Ø2.2 x L 10, 11, 12, 14, 16 mm
Ø2.3 x L 8, 9, 10, 12, 14 mm | | | | | | | | | | | | | | | |
| SSII 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 | | | | | | | | | | | | | | | |
| | 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
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
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.
6
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 predicate | ||||
| device | Predicate device | Reference device | Remark | ||
| Device Name | TSIII SA Implant | TSIII SA Implant | TSIII SA Implant | External Hex | |
| Implants | 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 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, screw | |||||
| 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 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. | 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, screw | |||||
| 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 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. | 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, screw | |||||
| retained, or | |||||
| overdenture | |||||
| restorations, and final | |||||
| or temporary | |||||
| abutment support for | |||||
| fixed bridgework. | |||||
| 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. | Southern Implants' | ||||
| External Hex | |||||
| Implants are intended | |||||
| for surgical placement | |||||
| in the upper or lower | |||||
| jaw to provide a | |||||
| means for prosthetic | |||||
| attachment of crowns, | |||||
| bridges or | |||||
| overdentures utilizing | |||||
| delayed or immediate | |||||
| loading. | |||||
| Southern Implants' | |||||
| External Hex | |||||
| Implants are intended | |||||
| for immediate | |||||
| function when good | |||||
| primary stability with | |||||
| appropriate occlusal | |||||
| 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 | |||||
| (L) | ø3.77 x L 7 mm | ||||
| ø4.25 x L 7 mm | |||||
| ø4.65 x L 7 mm | |||||
| ø5.45 x L 10, 11.5, | |||||
| 13, 15 mm | |||||
| ø5.48 x L 8.5 mm | |||||
| ø5.5 x L 7mm | ø5.05 x L 18 mm | 13, 15 mm | |||
| ø3.77 x L 8.5 mm | |||||
| ø4.2 x L 10, 11.5, 13, | |||||
| 15, 18 mm | |||||
| ø4.25 x L 7, 8.5 mm | |||||
| ø4.6 x L 10, 11.5, 13, | |||||
| 15 mm | |||||
| ø4.63 x L 8.5 mm | |||||
| ø4.65 x L 7 mm | |||||
| ø5.05 x L 10, 11.5, | |||||
| 13, 15 mm | |||||
| ø5.08 x L 8.5 mm | |||||
| ø5.1 x L 6.2, 7 | |||||
| mmø3.5 x L 8.5, 10, | |||||
| 11.5, 13, 15 mm | |||||
| ø4.2 x L 7, 8.5, 10, | |||||
| 11.5, 13, 15 mm | |||||
| ø4.4 x L 7, 8.5, 10, | |||||
| 11.5, 13, 15 mm | |||||
| ø4.9 x L 7, 8.5, 10, | |||||
| 11.5, 13, 15 mm | 11.5, 13, 15, 18 mm | ||||
| ø 3.75 x L 7, 8.5, 10, | |||||
| 11.5, 13, 15, 18, 20 | |||||
| mm | |||||
| ø 4.0 x L 6, 8.5, 10, | |||||
| 11.5, 13, 15, 18, 20 | |||||
| mm | |||||
| ø 4.7 x L 8.5, 10, | |||||
| 11.5, 13, 15, 18 mm | |||||
| ø 5.0 x L 6, 7, 8.5, | |||||
| 11.5, 13, 15, 18 mm | |||||
| ø 5.7 x L 10, 11.5, 13, | |||||
| 15, 18 mm | |||||
| ø 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 blasted | |
| Machine collar | |||||
| 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 |
| Similarities | |||||
| Proposed TSIII 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 TSIII SA Implant, K161604 and K121995. | |||||
| S.E. | Differences | ||||
| The proposed device has different range of dimensions than predicate device. However, the added diameter | |||||
| is larger than predicate device, so it is more stable than predicate device. Although there is the additional of | |||||
| extended 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- |
7
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 for | ||
| use in partially or fully edentulous | |||
| mandibles and maxillae, in support of | |||
| single or multiple-units restorations | |||
| including; cemented retained, screw | |||
| 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 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. | 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, screw | |||
| 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 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. | Same | ||
| Diameter (D) and | |||
| 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) | Titanium Alloy (ASTM F136) | Same |
| Surface | SA | SA | Same |
| Sterilization | Radiation Sterile | Radiation Sterile | Same |
| Shelf life | 8 years | 8 years | Same |
| S.E. | Similarities | ||
| Proposed TSIII SA Implant (Non-Hex) $Ø$ 3.2 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 TSIII SA Implant 3.2 (K161604). | |||
| Differences | |||
| The proposed TSIII SA Implant (Non-Hex) $Ø$ 3.2 is included in dimension range of predicate device | |||
| and has the same diameter of the embedding plane according to the ISO14801. However, proposed | |||
| TSIII SA Implant (Non-Hex) $Ø$ 3.2 has non hexagon connection that is different from predicate TSIII | |||
| SA Implant. Therefore, we conducted fatigue test according to ISO14801 and the test result does not | |||
| show 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 have | |||
| common 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 predicate | |||
| device. |
8
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 System | |||
| is indicated for use in | ||||
| partially or fully edentulous | ||||
| mandibles and maxillae, in | ||||
| support of single or | ||||
| multiple-units restorations | ||||
| including; cemented | ||||
| retained, screw 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 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. | 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, screw 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 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. | 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, screw retained, or | ||||
| overdenture restorations, | ||||
| and final or temporary | ||||
| abutment support for fixed | ||||
| bridgework. | ||||
| 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. | Same | |||
| Diameter (D) and | ||||
| Length (L) | ø3.75 x L 10, 11.5, 13 mm | |||
| ø3.77 x L 8.5 mm | ||||
| ø3.8 x L 8.5, 10, 11.5, 13, | ||||
| 15, 18 mm | ||||
| ø4.2 x L 10, 11.5, 13, 15, 18 | ||||
| mm | ||||
| ø4.25 x L 7, 8.5 mm | ||||
| ø4.6 x L 10, 11.5, 13, 15, 18 | ||||
| mm | ||||
| ø4.63 x L 8.5 mm | ø4.6 x L 18 mm | |||
| ø5.05 x L 18 mm | ø3.75 x L 10, 11.5, 13, 15 | |||
| mm | ||||
| ø3.77 x L 8.5 mm | ||||
| ø4.2 x L 10, 11.5, 13, 15, 18 | ||||
| mm | ||||
| ø4.25 x L 7, 8.5 mm | ||||
| ø4.6 x L 10, 11.5, 13, 15 | ||||
| mm | ||||
| ø4.63 x L 8.5 mm | ||||
| ø4.65 x L 7 mm | Different | |||
| ø4.65 x L 7 mm | ||||
| ø5.05 x L 10, 11.5, 13, 15, | ||||
| 18 mm | ||||
| ø5.08 x L 8.5 mm | ||||
| ø5.1 x L 7 mm | ø5.05 x L 10, 11.5, 13, 15 mm | |||
| ø5.08 x L 8.5 mm | ||||
| ø5.1 x L 6.2, 7 mmø3.5 x L | ||||
| 8.5, 10, 11.5, 13, 15 mm | ||||
| ø4.2 x L 7, 8.5, 10, 11.5, 13, | ||||
| 15 mm | ||||
| ø4.4 x L 7, 8.5, 10, 11.5, 13, | ||||
| 15 mm | ||||
| ø4.9 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. | Similarities | |||
| Proposed TSIII SA Implant (Non-Hex) 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 TSIII SA Implant, K161604 and K121995. | ||||
| Differences | ||||
| The 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 predicate | ||||
| TSIII SA Implant, but has the same diameter of the embedding plane as predicate device according to | ||||
| the ISO14801. Therefore, we selected the proposed device with the smallest diameter as the worst | ||||
| case and conducted fatigue test according to ISO14801, and the test result does not show any | ||||
| significant difference in regard of mechanical strength. | ||||
| Proposed TSIII SA Implant (Non-Hex) and the predicate TSIII SA Implant have common in | ||||
| design, 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 System | |||
| is indicated for use in | ||||
| partially or fully edentulous | ||||
| mandibles and maxillae, in | ||||
| support of single or | ||||
| multiple-units restorations | ||||
| including; cemented | ||||
| retained, screw 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 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. | 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, screw 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 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. | Southern Implants' External | |||
| Hex Implants are intended | ||||
| for surgical placement in the | ||||
| upper or lower jaw to | ||||
| provide a means for | ||||
| prosthetic attachment of | ||||
| crowns, bridges or | ||||
| overdentures utilizing | ||||
| delayed or immediate | ||||
| loading. | ||||
| Southern Implants' External | ||||
| Hex Implants are intended | ||||
| for immediate function | ||||
| when good primary stability | ||||
| with appropriate occlusal | ||||
| loading is achieved. | Same | |||
| Diameter (D) and | ||||
| Length (L) | Ø4.4 x L 18 mm | |||
| Ø4.8 x L 18 mm | ||||
| Ø5.25 x L 18 mm | Ø4.4 x L 7, 8.5, 10, 11.5, 13, | |||
| 15 mm | ||||
| Ø4.8 x L 7, 8.5, 10, 11.5, 13, | ||||
| 15 mm | ||||
| Ø5.25 x L 7, 8.5, 10, 11.5, | ||||
| 13, 15 mm | Ø 3.25 x L 8.5, 10, 11.5, 13, | |||
| 15, 18 mm | ||||
| Ø 3.75 x L 7, 8.5, 10, 11.5, | ||||
| 13, 15, 18, 20 mm | ||||
| Ø 4.0 x L 6, 8.5, 10, 11.5, | ||||
| 13, 15, 18, 20 mm | ||||
| Ø 4.7 x L 8.5, 10, 11.5, 13, | ||||
| 15, 18 mm | ||||
| Ø 5.0 x L 6, 7, 8.5, 11.5, 13, | ||||
| 15, 18 mm | ||||
| Ø 5.7 x L 10, 11.5, 13, 15, | ||||
| 18 mm | ||||
| Ø 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 blasted | |
| Machine collar versions | Same | |||
| available | ||||
| External Hex | ||||
| Sterilization | Radiation Sterile | Radiation Sterile | NA | Same |
| Shelf life | 8 years | 8 years | NA | Same |
| S.E. | Similarities | |||
| Proposed TSIV 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 TSIV SA Implant (K161604). |
Differences
There is the additional of extended implant lengths of 18mm, 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.
.: 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 TSIV
SA 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 shape | ||
| until setting up prosthetics. | |||
| It is intended use to combine with | |||
| implanted fixture after osseointegration | |||
| then removing cover screw. | Used to make a natural soft tissue shape | ||
| until setting up prosthetics. | |||
| It is intended use to combine with | |||
| implanted fixture after osseointegration | |||
| then removing cover screw. | Same | ||
| Diameter (D) and | |||
| 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 | |||
| ø4.8 x L 5.5, 5.6, 6.5, 6.6, 7.5, 7.6, 9.5, 9.6, | |||
| 11.5 mm | |||
| ø5.3 x L 5.5, 6.5, 7.5, 9.5, 11.5 mm | |||
| ø6.3 x L 5.5, 6.5, 7.5, 9.5, 11.5 mm | |||
| ø7.3 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 mm | |||
| ø4.8 x L 7.5, 8.5, 9.5, 10.5, 11.5, 12.5, 13.5, | |||
| 14.5 mm | |||
| ø5.3 x L 8.5, 9.5, 10.5, 12.5, 14.5 mm | |||
| ø6.3 x L 8.5, 9.5, 10.5, 12.5, 14.5 mm | |||
| ø7.3 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
| | Screw
Ø2.2 x L 10, 11, 12, 14, 16 mm
Ø2.3 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. | Similarities
Proposed TS Scan Healing Abutment has same function and indication for use; and is made with
same material with same manufacturing process by same manufacturer compared to that of the
predicate Healing Abutment (K161604).
Differences
There is difference between proposed device and predicate on design. The predicate device has a
screw-combined design compared to the proposed device. In addition, since TS Scan Healing
Abutment is used temporarily to make natural soft tissue shape until setting up prosthetics, it does not
require any performance. Therefore, we didn't consider additional performance testing.
: . Proposed TS Scan Healing Abutment and the predicate Healing Abutment have common in
function, indications for use, material, manufacturing process, manufacturer, etc.; therefore, the
proposed 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 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, screw | ||||
| retained, or overdenture | The Osstem Implant is | |||
| indicated for use in partially | ||||
| or fully edentulous | ||||
| mandibles and maxillae, in | ||||
| support of single or multiple- | ||||
| unit restorations including; | ||||
| cemented retained, screw | ||||
| retained, or overdenture | Southern Implants' External | |||
| Hex Implants are intended | ||||
| for surgical placement in the | ||||
| upper or lower jaw to | ||||
| provide a means for | ||||
| prosthetic attachment of | ||||
| crowns, bridges or | ||||
| overdentures utilizing | Same | |||
| 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 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. | restorations, and finally 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. | delayed or immediate | |||
| loading. | ||||
| Southern Implants' External | ||||
| Hex Implants are intended | ||||
| for immediate function when | ||||
| good primary stability with | ||||
| appropriate occlusal loading | ||||
| is achieved. | ||||
| Appearance | Image: Implant | Image: Implant | NA | Different |
| Dimension | ø 4.8 x L 7, 8.5, 10, 11.5, 13, | |||
| 15 mm | ||||
| ø 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 mm | ||||
| ø 4.45 x L 7, 8.5, 10, 11.5, | ||||
| 13, 15 mm | ||||
| ø 4.9 x L 7, 8.5, 10, 11.5, 13, | ||||
| 15 mm | ||||
| ø 5.0 x L 6 mm | ø 3.25 x L 8.5, 10, 11.5, 13, | |||
| 15, 18 mm | ||||
| ø 3.75 x L 7, 8.5, 10, 11.5, | ||||
| 13, 15, 18, 20 mm | ||||
| ø 4.0 x L 6, 8.5, 10, 11.5, 13, | ||||
| 15, 18, 20 mm | ||||
| ø 4.7 x L 8.5, 10, 11.5, 13, | ||||
| 15, 18 mm | ||||
| ø 5.0 x L 6, 7, 8.5, 11.5, 13, | ||||
| 15, 18 mm | ||||
| ø 5.7 x L 10, 11.5, 13, 15, 18 | ||||
| mm | ||||
| ø 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 blasted | |
| Machine collar versions | ||||
| available | 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. | Similarities | |||
| Proposed SSII 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 SSII SA Implant (K163557). |
Differences
In 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 identical | |
| in all implanted parts. In addition, since the diameter of embedding plane is same as predicate device, we | |
| didn'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 mm | |||
| ø 60 x L 7, 8.5, 10, 11.5, 13, 15 mm | ø 3.75 x L 8.5, 10, 11.5, 13 mm | |||
| ø 4.25 x L 7, 8.5, 10, 11.5, 13 mm | ||||
| ø 4.6 x L 7, 8.5, 10, 11.5, 13 mm | ||||
| ø 5.0 x L 10, 11.5, 13 mm | ||||
| ø 5.05 x L 6, 7, 8.5 mm | ø 3.25 x L 8.5, 10, 11.5, 13, 15, 18 mm | |||
| ø 3.75 x L 7, 8.5, 10, 11.5, 13, 15, 18, 20 mm | ||||
| ø 4.0 x L 6, 8.5, 10, 11.5, 13, 15, 18, 20 mm | ||||
| ø 4.7 x L 8.5, 10, 11.5, 13, 15, 18 mm | ||||
| ø 5.0 x L 6, 7, 8.5, 11.5, 13, 15, 18 mm | ||||
| ø 5.7 x L 10, 11.5, 13, 15, 18 mm | ||||
| ø 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 blasted | |
| Machine 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. | Similarities | |||
| Proposed 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). |
Differences
There 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 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, screw 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 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. | The Osstem Implant is indicated for use in | ||
| partially or fully edentulous mandibles and | |||
| maxillae, in support of single or multiple-unit | |||
| restorations including; cemented retained, | |||
| screw retained, or overdenture restorations, | |||
| and finally 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. | Same | ||
| Dimension | Ø 6.0 x L 7, 8.5, 10, 11.5, 13 mm | Ø 5.92 x L 11.5, 13 mm | |
| Ø 5.95 x L 10 mm | |||
| Ø 5.96 x L 6, 8.5 mm | |||
| Ø 6.0 x L 7 mm | |||
| Ø 6.8 x L 7, 8.5, 10, 11.5, 13 mm | |||
| Ø 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
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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 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
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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.