(132 days)
No
The summary describes a physical dental abutment system made of titanium alloy and focuses on mechanical and biocompatibility testing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is intended to provide support for prosthetic restorations, which is a structural and restorative function, not a therapeutic one.
No
The device is described as providing support for prosthetic restorations and is made of titanium alloy for use with dental implants. Its purpose is structural support, not to diagnose medical conditions or analyze data for diagnostic insights.
No
The device description explicitly states the device is made of "titanium alloy," indicating it is a physical hardware component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide support for prosthetic restorations in the mouth, which is a mechanical function within the body.
- Device Description: The device is a physical component made of titanium alloy, designed to be implanted and support dental prosthetics.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
The device is clearly a dental implant component used for structural support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The OSSTEM Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
SS Abutment System is made of titanium alloy. SS Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. SS Abutment 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
Not Found
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)
Non-clinical testing data are submitted to demonstrate substantial equivalence.
Biocompatibility Evaluation: Biocompatibility testing was considered followed the FDA Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, " The SS Abutment System has same materials, manufacturer, manufacturing process etc., as predicate devices. Therefore, we didn't conduct additional biocompatibility test.
Sterilization Validation and Shelf-life: Validation of the gamma irradiation process was previously conducted for the predicated device. There has been no change to the manufacturing or sterilization processes since then and the subject devices do not present a new worst case for sterilization validation; therefore, additional validation is not required. In addition, SS Abutment System are made with titanium and titanium alloy we don't consider about shelf life of material by itself because this metal is widely known that it generally has no adversely affect by aging. Therefore we certify that product such like metal has no shelf life.
Mechanical Properties: Fatigue testing was considered according to the FDA Guidance Document Guidance for Industry and FDA Staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment and ISO 14801 standard with the worst case scenario. The subject devices do not provide a new worst case for fatigue testing because they are all straight.
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 variations (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
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
December 5, 2023
Osstem Implant Co., Ltd. % Peter Lee RA/OA Manager HioSSEN Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030
Re: K232220
Trade/Device Name: SS Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 31, 2023 Received: November 2, 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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
3
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,
Andrew I. Steen -S
Andrew I. 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
Enclosure
3
Indications for Use
510(k) Number (if known) K232220
Device Name SS Abutment System
Indications for Use (Describe)
The OSSTEM Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
Implant Co., Lt g-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
510(k) Summary K232220
Date: December 5, 2023
1. Company and Correspondent making the submission
| - | Submitter's Name | : | Osstem Implant Co., Ltd. |
|---|---|---|---|
| - | Address | : | 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, |
| 48002, Republic of Korea | |||
| - | Contact | : | Ms. Seungju Kang |
| - | Phone | : | +82-51-850-2500 |
| - | 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 | : SS Abutment System |
|---|---|
| - Classification Name | : Endosseous dental implant Abutment |
| - Regulation Number | : 21 CFR 872.3630 |
| - Devce Classification | : Class II |
| - Classification Product Code | : NHA |
3. Predicated and Reference Devices
| Primary Predicate | |
|---|---|
| K160670 | US/SS/GS System |
| Reference Device | |
| K182091 | Osstem Abutment System |
| K062051 | SS System |
4. Indication for use
The OSSTEM Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.
5. Device Description
SS Abutment System is made of titanium alloy. SS Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
5
Image /page/5/Picture/0 description: The image contains the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a stylized font, with the word "IMPLANT" written in a smaller font below it. The logo is simple and clean, and it is likely used to represent the company and its products.
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
SS Abutment System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.
| Device | Content | |
|---|---|---|
| ComOcta Plus Abutment | Description | It is used for making general cement- retained/combination prosthesis and used for thick gingiva or deeply placed implant. |
| Material | Ti-6Al-4V (ASTM F136), TiN Coating | |
| Diameter (D) and Length (L) | Ø5.5 x L 5, 6, 7, 7.5, 8, 9.5 | |
| Ø6.0 x L 7.5 | ||
| Ø6.5 x L 5, 6, 7, 8, 8.5, 10 | ||
| Ø6.8 x L 7.5 | ||
| Ø7.0 x L 9.5 | ||
| Ø7.2 x L 8.5 | ||
| Ø7.6 x L 9.5 | ||
| ComOcta Milling Abutment | Description | It is used as cement/combination-retained prosthesis and it is used when the abutment's margin shape needs corrections. This device is intended to be modified chairside by the clinician. |
| Material | Ti-6Al-4V (ASTM F136) | |
| Diameter (D) and Length (L) | Ø5.5 x L 14 | |
| Ø6.5 x L 14.35 | ||
| ComOcta Protect Cap | Description | It is made of plastic material and formed with a cover cap to protect porous upper structure. |
| Material | POM | |
| Diameter (D) and Length (L) | Ø5.3 x L 6.35, 7.85, 9.35 | |
| Port Abutment | Description | Port Abutment is used for prosthetic restoration. It is for implant retained overdenture at maxilla/mandible in case of the patient has no teeth. |
| Material | Ti-6Al-4V (ASTM F136), TiN Coating | |
| Diameter (D) and Length (L) | Ø6.06 x L 3.5, 4.5, 5.5, 6.5 | |
| O-ring Abutment | Description | It is used for overdenture with O-ring attachment. |
| Material | Ti-6Al-4V (ASTM F136) | |
| Diameter (D) and Gingiva Height (G/H) | Ø4.3 x G/H 0, 2, 4 | |
| Material | Titanium Gr 3 (ASTM F67) | |
| Diameter (D) and Length (L) | Ø4.8 x L 8.2 | |
| Ø6.0 x L 8.2 | ||
| Closing Screw | Description | It is used to protect the exposed platform of the implant during healing period |
| Material | Titanium Gr 4 (ASTM F67) | |
| Diameter (D) and | ||
| Length (L) | $\text{\O}3.5$ x L 6.0 | |
| $\text{\O}4.3$ x L 6.4 |
The specifications of the proposed device are as follow;
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Image /page/6/Picture/0 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, lighter font. The logo is simple and modern, and it is likely used to represent the company's brand.
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
6. Substantial Equivalence Matrix
These subject devices are cleared in past 510(k); therefore, indication for use, shape, connection structure, material, surface treatment, manufacturer and etc. are the same with predicated devices except dimension of additional products.
| Subject Device | Primary Predicate Device | Remark | |
|---|---|---|---|
| Device Name | ComOcta Plus Abutment | ComOcta Plus Abutment | Same |
| 510(k) | |||
| Number | - | K160670 | - |
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same |
| Design | Image: Two ComOcta Plus Abutments | Image: Two ComOcta Plus Abutments | Same |
| Indication for | |||
| Use | The OSSTEM Prosthetic system | ||
| is intended for use with a dental | |||
| implant to provide support for | |||
| prosthetic restorations such as | |||
| crowns, bridges, or over- | |||
| dentures. | The OSSTEM Prosthetic system | ||
| is intended for use with a dental | |||
| implant to provide support for | |||
| prosthetic restorations such as | |||
| crowns, bridges, or over- | |||
| dentures. | Same | ||
| Principle of | |||
| Operation | As general cement retained | ||
| restoration, it is connected with | |||
| fixture and cemented crown on | |||
| the abutment | As general cement retained | ||
| restoration, it is connected with | |||
| fixture and cemented crown on | |||
| the abutment | Same | ||
| Diameter (D) | |||
| and Length | |||
| (L) | Ø5.5 x L 5, 6, 7, 7.5, 8, 9.5 | ||
| Ø6.0 x L 7.5 | |||
| Ø6.5 x L 5, 6, 7, 8, 8.5, 10 | |||
| Ø6.8 x L 7.5 | |||
| Ø7.0 x L 9.5 | |||
| Ø7.2 x L 8.5 | |||
| Ø7.6 x L 9.5 | Ø5.5 x L 6.5, 7.5, 8.5, 9.5 | ||
| Ø6.5 x L 6.5, 7.5, 8.5, 9.5 | Different | ||
| Material | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) | Same |
| S.E. | Similarities | ||
| Proposed ComOcta Plus Abutment has same design, function and indication for | |||
| use; and is made with same material with same manufacturing process by same | |||
| manufacturer compared to that of the predicate ComOcta Plus Abutment, | |||
| K160670. |
7
Image /page/7/Picture/0 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, lighter font. The logo is simple and modern.
Osstem Implant Co., Ltd.
OSSTEM Implant Co., Ltd., Ltd., 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
| Differences
The diameter Ø5.5 ~ Ø7.6 of proposed device differs from predicate device; but is
included in the dimension range of the predicate device, except for the larger
diameters Ø6.8 ~ Ø7.6. But they are larger than predicate device, so it is
considered to have equal to or greater performance than that of the predicate
| device. |
|---|
| The diameter Ø5.5 and Ø6.5 of proposed device are same and there is only |
| difference in the length 5mm and 6mm which is smaller than the predicate device. |
| However, proposed device has same design, function, connection and platform etc |
| as predicate deivce. In addition, since proposed device is straight type and the |
| distance between the embedding plane and the centre of the hemispherical hoading |
| member always is 11mm according to the ISO 14801, it has same moment arm. |
| As a result, the fatigue of the proposed device is considered to be equal to or |
| greater than that of the predicate device. Therefore, we don't conduct additional |
| fatigue testing. |
| : Proposed ComOcta Plus Abutment and the predicate device have common in |
| design, function, indications for use, material, manufacturing process, |
| manufacturer, etc.; therefore, the proposed device is substantially equivalent to the |
| predicate device. |
| Subject Device | Predicate Device | Remark | |
|---|---|---|---|
| Device Name | ComOcta Milling Abutment | ComOcta Plus Abutment | Different |
| 510(k) | |||
| Number | - | K160670 | - |
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same |
| Design | Image: ComOcta Milling Abutment | Image: ComOcta Plus Abutment | Different |
| Indication for | |||
| Use | The OSSTEM Prosthetic system | ||
| is intended for use with a dental | |||
| implant to provide support for | |||
| prosthetic restorations such as | |||
| crowns, bridges, or over-dentures. | The OSSTEM Prosthetic system | ||
| is intended for use with a dental | |||
| implant to provide support for | |||
| prosthetic restorations such as | |||
| crowns, bridges, or over-dentures. | Same | ||
| Principle of | |||
| Operation | As general cement retained | ||
| restoration, it is connected with | As general cement retained | ||
| restoration, it is connected with | Same |
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Image /page/8/Picture/0 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, sans-serif font. The logo is simple and modern.
Osstem Implant Co., Ltd.
Osstem Implant Co., و Ltd.
66-16, Bansong-ro 513beon-gil, Haundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
| | fixture and cemented crown on
the abutment | fixture and cemented crown on
the abutment | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|-----------|
| Diameter (D)
and Length
(L) | Ø5.5 x L 14
Ø6.5 x L 14.35 | Ø5.5 x L 6.5, 7.5, 8.5, 9.5
Ø6.5 x L 6.5, 7.5, 8.5, 9.5 | Different |
| Material | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) | Same |
| S.E. | Similarities
Proposed ComOcta Milling 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 predicated ComOcta Plus Abutment,
K160670.
Differences
The length 14mm and 14.35mm of proposed device is not included in dimension
range of predicate device. However, the diameter range of proposed device is
same as predicate device, and since the proposed device is compatible with the
same implant as predicate device, it has same design, function, connection and
platform etc as predicate deivce. In addition, since proposed device is straight type
and the distance between the embedding plane and the centre of the hemispherical
hoading member always is 11mm according to the ISO 14801, it has same
moment arm.
As a result, the fatigue of the proposed device is considered to be equal to or
greater than that of the predicate device. Therefore, we don't conduct additional
fatigue testing.
The ComOcta Milling Abutment can be modified chairside by hand, to a
minimum post height 4mm, and a gingival height between 1mm and 3mm, with
no angulation allowed. These dimensions are not significantly different compared
to the predicate device and do not present a new worst case for performance
testing. In addition, proposed ComOcta Milling Abutment and the predicate
ComOcta Plus Abutment have common in design, function, indications for use,
material, manufacturing process, manufacturer, etc.; therefore, the proposed | | |
| Subject Device | Predicate Device | Remark | |
|---|---|---|---|
| Device Name | ComOcta Protect Cap | ComOcta Retraction Cap | Different |
| 510(k) | |||
| Number | - | K160670 | - |
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same |
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Image /page/9/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in orange, and the word "IMPLANT" is in a smaller, gray font below it. There is a small circle to the right of the word "OSSTEM".
sstem Implant Co., Ltd.
Osstem Implant Co., و Ltd.
66-16, Bansong-ro 513beon-gil, Haundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
| Design | Image: cap | Image: cap | Different |
|---|---|---|---|
| Indication for | |||
| Use | The OSSTEM Prosthetic system | ||
| is intended for use with a dental | |||
| implant to provide support for | |||
| prosthetic restorations such as | |||
| crowns, bridges, or over-dentures. | The OSSTEM Prosthetic system | ||
| is intended for use with a dental | |||
| implant to provide support for | |||
| prosthetic restorations such as | |||
| crowns, bridges, or over-dentures. | Same | ||
| Principle of | |||
| Operation | ComOcta Protect Cap is | ||
| temporary connected with | |||
| ComOcta abutment for minimize | |||
| foreign body sensation by the | |||
| patient | ComOcta Retraction Cap is | ||
| temporary connected with | |||
| ComOcta abutment for minimize | |||
| foreign body sensation by the | |||
| patient and accurate margin | |||
| impression function when taking | |||
| impression directly from a | |||
| ComOcta abutment. | Same | ||
| Diameter (D) | |||
| and Length | |||
| (L) | Ø5.3 x L 6.35, 7.85, 9.35 | Ø6.4 x L 6.25, 7.75, 9.25 | |
| Ø7.7 x L 6.1, 7.6, 9.1 | Different | ||
| Material | POM | POM | Same |
| Similarities | |||
| Proposed ComOcta Protect Cap has same function, indication for use; and is made | |||
| with same material with same manufacturing process by same manufacturer | |||
| compared to that of the predicated ComOcta Retraction Cap, K160670. |
Differences
The diameter Ø5.3 of proposed device is smaller than that of predicate device and
the length 6.35 ~ 9.35mm of proposed device differs from predicate device.
Although there are differences in dimension range and feature, proposed device
has same compatible device, ComOcta Abutment, and principle of operation with
predicate device. In addition, proposed device is made of POM
(Polyoxymethylene) which is same raw material of predicate device.
... Proposed ComOcta Protect Cap and the predicated device have common in
design, function, indications for use, material, manufacturing process,
manufacturer, etc.; therefore, the proposed device is substantially equivalent to the
predicated device. | | |
| Subject Device | Reference Device | Remark | |
|---|---|---|---|
| Device Name | Port Abutment | Port Abutment | Same |
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Image /page/10/Picture/0 description: The image contains 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, sans-serif font. The logo is simple and modern.
Osstem Implant Co., Ltd..
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
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
| 510(k)
| Number | - | K182091 | - |
|---|---|---|---|
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same |
| Design | Image: Prosthetic system | Image: Abutment System | Same |
| Indication for | |||
| Use | The OSSTEM Prosthetic system | ||
| is intended for use with a dental | |||
| implant to provide support for | |||
| prosthetic restorations such as | |||
| crowns, bridges, or over-dentures. | The Osstem Abutment System is | ||
| intended for use with a dental | |||
| implant to provide support for | |||
| prosthetic restorations such as | |||
| crowns, bridges, or overdentures. | Same | ||
| Principle of | |||
| Operation | Using making implant retained | ||
| overdenture at maxilla/mandible. | Using making implant retained | ||
| overdenture at maxilla/mandible. | Same | ||
| Diameter (D) | |||
| and Length | |||
| (L) | $Ø$ 6.06 x L 3.5, 4.5, 5.5, 6.5 | $Ø$ 4.8 x L 2.5, 3.5, 4.5, 5.5, 6.5 | Different |
| Material | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) | Same |
| S.E. | Similarities | ||
| Proposed Port Abutment has same design, function and indication for use; and is | |||
| made with same material with same manufacturing process by same manufacturer | |||
| compared to that of the reference device Port Abutment, K182091. | |||
| Differences | |||
| The only difference is that the proposed device has a diameter $Ø$ 6.06 compared to | |||
| the reference device diameter $Ø$ 4.8. However, added diameter is bigger than | |||
| reference device and the lengths 3.5~6.5mm is same as the range of reference | |||
| device. In addition, proposed device is straight type and is not received single load | |||
| because this is used for making overdenture that means load is dispersed to the | |||
| full denture. Therefore, we don't consider additional fatigue testing. | |||
| . . Proposed Port Abutment and the predicate device have common in design, | |||
| function, indications for use, material, manufacturing process, manufacturer, etc.; | |||
| therefore, the proposed device is substantially equivalent to the predicate device. |
| Subject Device | Reference Device | Remark | |
|---|---|---|---|
| Device Name | O-ring Abutment | O-ring Abutment | Same |
| 510(k) Number | - | K062051 | - |
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same |
11
Image /page/11/Picture/0 description: The image shows the logo for Osstem Implant. The logo is in orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, lighter font. The logo is simple and modern.
Osstem Implant Co., Ltd.
Osstem Implant Co., و Ltd.
66-16, Bansong-ro 513beon-gil, Haundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
| Design | Image: Prosthetic system design 1 | Image: Prosthetic system design 2 | Same |
|---|---|---|---|
| Indication for | |||
| Use | The OSSTEM Prosthetic system | ||
| is intended for use with a dental | |||
| implant to provide support for | |||
| prosthetic restorations such as | |||
| crowns, bridges, or over-dentures. | SS system in 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 | |||
| terminal or intermediate abutment | |||
| support for fixed bridgework. SS | |||
| System is for single stage surgical | |||
| procedures | Same | ||
| Principle of | |||
| Operation | Using making stud type | ||
| overdenture prosthetics. | Using making stud type | ||
| overdenture prosthetics. | Same | ||
| Diameter (D) | |||
| and Gingiva | |||
| Height (G/H) | $Ø4.3$ x G/H 0, 2, 4 | $Ø3.5$ x G/H 0, 2, 4 | Different |
| Material | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) | Same |
| S.E. | Similarities | ||
| Proposed O-ring Abutment has same design, function and indication for use; and | |||
| is made with same material with same manufacturing process by same | |||
| manufacturer compared to that of the reference O-ring Abutment, K062051. | |||
| Differences | |||
| The only difference is that the proposed device has a diameter $Ø4.3$ compared to | |||
| the reference device diameter $Ø3.5$ . However, added diameter is bigger than | |||
| reference device and the gingiva height 0~4mm is same as the range of predicate | |||
| device. In addition, proposed device is straight type and is not received single load | |||
| because this is used for making overdenture that means load is dispersed to the | |||
| full denture. Therefore, we don't consider additional fatigue testing. | |||
| . . Proposed O-ring Abutment and the predicate device have common in design, | |||
| function, indications for use, material, manufacturing process, manufacturer, etc.; | |||
| therefore, the proposed device is substantially equivalent to the predicate device. | |||
| Subject Device | Reference Device | Remark | |
| Device Name | Closing Screw | Closing Screw | Same |
| 510(k) Number | - | K062051 | - |
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same |
| Design | Image: dental implant | Image: dental implant | Different |
| Indication for | |||
| Use | The OSSTEM Prosthetic system | ||
| is intended for use with a dental | |||
| implant to provide support for | |||
| prosthetic restorations such as | |||
| crowns, bridges, or over-dentures. | SS system in 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 | |||
| terminal or intermediate abutment | |||
| support for fixed bridgework. SS | |||
| System is for single stage surgical | |||
| procedures | Same | ||
| Principle of | |||
| Operation | It is connected with placed | ||
| implant to protect other | |||
| substances from ingressing into | |||
| the fixture after the surgical | |||
| operation. | It is connected with placed | ||
| implant to protect other | |||
| substances from ingressing into | |||
| the fixture after the surgical | |||
| operation. | Same | ||
| Diameter (D) | |||
| and Length (L) | Ø3.5 x L 6.0 | ||
| Ø4.3 x L 6.4 | Ø3.5 x L 5.5 | ||
| Ø4.3 x L 5.85 | Different | ||
| Material | Titanium Gr 4 | Titanium Gr 4 | Same |
| Sterilization | Radiation Sterile | Radiation Sterile | Same |
| Shelf life | 8 years | 8 years | Same |
| S.E. | Similarities | ||
| Proposed Closing Screw has same diameter dimension, design, function and | |||
| indication for use; and is made with same material with same manufacturing | |||
| process by same manufacturer compared to that of the predicated Closing Screw, | |||
| K062051. | |||
| Differences | |||
| Although there are differences in dimensions that the proposed device is longer | |||
| than predicate device, it does not affect safety and effectiveness because it is used | |||
| to protect the exposed platform of the implant during healing period. | |||
| :. Proposed Closing Screw and the predicate device have common in design, |
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Image /page/12/Picture/0 description: The image contains 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, sans-serif font. The logo is simple and modern.
Osstem Implant Co., Ltd.
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
13
OSTEM
IMPLANT
Dsstem Implant Co.. Ltd
-16. Bansong-ro 513beon-gil. Haeundae-gu. Busan. Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
therefore, the proposed device is substantially equivalent to the predicate device. Summary of Non-clinical Performance Testing 7.
Non-clinical testing data are submitted to demonstrate substantial equivalence.
Biocompatibility Evaluation
Biocompatibility testing was considered followed the FDA Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, " The SS Abutment System has same materials, manufacturer, manufacturing process etc., as predicate devices. Therefore, we didn't conduct additional biocompatibility test.
Sterilization Validation and Shelf-life
Validation of the gamma irradiation process was previously conducted for the predicated device. There has been no change to the manufacturing or sterilization processes since then and the subject devices do not present a new worst case for sterilization validation; therefore, additional validation is not required. In addition, SS Abutment System are made with titanium and titanium alloy we don't consider about shelf life of material by itself because this metal is widely known that it generally has no adversely affect by aging. Therefore we certify that product such like metal has no shelf life.
Mechanical Properties
Fatigue testing was considered according to the FDA Guidance Document Guidance for Industry and FDA Staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment and ISO 14801 standard with the worst case scenario. The subject devices do not provide a new worst case for fatigue testing because they are all straight.
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 variations (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.
8. Summary of Clinical Testing
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 SS Abutment System is substantially equivalent to the predicated devices as herein.