(411 days)
ET System: The HIOSSEN Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.
US/SS System: 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 ET US SS Prosthetic system is intended for use as an aid in prosthetic restoration. It is consisted of abutments, components and abutment screws.
The provided document is a 510(k) Premarket Notification from the FDA for a dental prosthetic system. It details the device, its intended use, and its substantial equivalence to predicate devices based on nonclinical testing. However, it does not contain acceptance criteria for device performance, nor does it describe a study proving the device meets specific performance criteria in terms of clinical effectiveness or accuracy.
Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices, which is a different regulatory pathway than proving novel performance. Substantial equivalence is established by showing that the new device has the same intended use and the same technological characteristics as the predicate device, or, if it has different technological characteristics, that the different characteristics do not raise new questions of safety and effectiveness and that the device is as safe and effective as the predicate device.
Here's an analysis of the information available in the document, keeping in mind that it's a substantial equivalence filing rather than a performance validation study against acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The document primarily identifies the device's characteristics (materials, dimensions, intended use) and compares them to predicate devices to establish substantial equivalence. It does not list quantitative acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity, or success rates) or specific performance metrics that the device is intended to meet.
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable in the context of the provided document. The submission explicitly states:
- "No clinical studies are submitted." (Page 22)
- The nonclinical testing primarily involves fatigue testing and biocompatibility evaluations, which are typically performed on samples of the device components rather than a "test set" of patient data. The sample sizes for these engineering tests are not specified in this summary.
- Data provenance for clinical data is not applicable as no clinical data was submitted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as no clinical studies with a test set requiring ground truth establishment by experts were submitted.
4. Adjudication Method for the Test Set
This information is not applicable as no clinical studies with a test set requiring adjudication were submitted.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The device described is a physical dental prosthetic system (abutments, screws, caps), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related effect sizes are not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This information is not applicable for the same reason as point 5. The device is a physical prosthetic, not an algorithm.
7. The Type of Ground Truth Used
This information is not applicable as no clinical studies requiring ground truth were submitted. The basis for safety and effectiveness is substantial equivalence to predicate devices, supported by nonclinical testing (fatigue, biocompatibility, sterilization validation).
8. The Sample Size for the Training Set
This information is not applicable. There is no mention of a "training set" as this device is not an AI/machine learning product and no clinical data or algorithms are being trained.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set mentioned in relation to this device.
Summary of the Study and "Acceptance Criteria" (as interpreted from the document's context):
The "study" described in the document is primarily focused on nonclinical testing and demonstrating substantial equivalence to predicate devices rather than fulfilling specific performance acceptance criteria for clinical outcomes.
Acceptance Criteria (Implicit from Substantial Equivalence):
From the context of a 510(k) submission, the "acceptance criteria" are implicitly met if the device can demonstrate that it is as safe and effective as a legally marketed predicate device. This is achieved by showing:
- Same Intended Use: The ET US SS Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations (crowns, bridges, over-dentures), which is identical to the indications for use of its identified predicate and reference predicate devices (e.g., K062030, K130662).
- Same Technological Characteristics OR Equivalent Safety/Effectiveness with Different Characteristics:
- Material: Titanium Alloy, PEEK, Polymer (Polycarbonate, POM) – consistent with predicate devices.
- Design & Function: Described as similar in various components (e.g., Quick Temporary Abutment, Solid Abutment, ComOcta Abutment, Healing Abutment, Ti Screw, O-ring Abutment, Multi Angled Abutment, Esthetic-low Temporary Cylinder). Where there are differences (e.g., new dimensions, slight shape changes, different connection structures for Multi Angled Abutments), the submission asserts that these differences "do not raise new questions of safety and effectiveness" and that the device maintains "same principles of operation, function, material, characteristic and intended use."
- Biocompatibility: Stated to be the same as predicates, thus requiring no additional testing.
- Sterilization: For Cover Screw and Healing Abutment, considered substantially equivalent to a predicate. Other components are non-sterile and require steam sterilization validation according to ISO 17665-1:2006. The results implicitly meet the standard.
- Fatigue Testing: Performed according to "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with a worst-case scenario. The implied acceptance is that the device met the fatigue strength requirements comparable to the predicate devices or within safe limits for its intended use, ensuring structural integrity. Specific results or detailed criteria are not laid out, but the successful completion of these tests supports substantial equivalence.
Reported Device Performance (from the perspective of 510(k) substantial equivalence):
The document reports the device's performance by demonstrating its similarities to predicate devices across various characteristics:
- Materials: Predominantly Titanium Alloy (ASTM F 136), Titanium (ASTM F 67), and various polymers (PEEK, Polycarbonate, PolyOxy Methylene). These are well-established materials in dental prosthetics, matching those of the predicate devices.
- Dimensions: Various diameters and heights are listed for each component, often including new dimensions that are added to existing product lines. The claim is that these new dimensions do not alter the fundamental safety or effectiveness and maintain the "same principles of operation, function, material, characteristic and intended use" as the predicate devices.
- Functional Principles: Described for each component (e.g., "Used to make temporary prosthesis," "Used in producing ordinary cement-retained prosthetics," "Connect an abutment with fixture by screw"). These are consistently aligned with the predicate device functions.
- Nonclinical Test Results:
- Biocompatibility: Implicitly deemed acceptable due to using the same materials, manufacturing processes, surface treatments, and sterilization methods as legally marketed predicate devices.
- Sterilization Validation: Cover Screw and Healing Abutment results are "considered to be substantial equivalent" to a specific predicate, indicating adequate sterilization protocols. Other non-sterile devices underwent steam sterilization validation to ISO 17665-1:2006, implying successful validation.
- Fatigue Testing: Performed on a "worst-case scenario" sample, suggesting that the device's mechanical durability was assessed and found satisfactory based on the relevant guidance document, thereby supporting its structural integrity and equivalence.
In conclusion, the document demonstrates that the ET US SS Prosthetic System meets the "acceptance criteria" for a 510(k) submission by establishing its substantial equivalence to predicate devices through a comparison of technological characteristics and successful nonclinical testing for biocompatibility, sterilization, and fatigue. No clinical performance criteria or studies are presented.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 25, 2017
OSSTEM Implant Co., Ltd. % David Kim Manager HiOSSEN Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030
Re: K160670
Trade/Device Name: ET US SS Prosthetic System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 12, 2017 Received: April 12, 2017
Dear David Kim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The logo includes the company name in bold, black font, with the word "OSSTEM" in orange to the left of the company name. Below the company name is the address: 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea. The phone number is +82 51 850-2500, the fax number is +82 51 850-4341, and the website is www.osstem.com.
Indications for Use Statement
_K160670 510(k) Number
Device Name: ET US SS Prosthetic system
Indication for use:
ET System
The HIOSSEN Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.
US/SS System
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.
Prescription Use X (Per 21CFR801 Subpart D) OR
Over-The-Counter Use (Per 21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
510(k) Summary
Date: April 25, 2017
- Company and Correspondent making the submission:
| - Submitter's Name: | OSSTEM Implant Co., Ltd. |
|---|---|
| - Address: | 66-16, Bansong-ro 513beon-gil, Haeundae-gu,Busan, Republic of Korea |
| - Contact: | Mr. Hee Kwon Son |
| - Phone: | +82 51 850 2575 |
| - Correspondent's Name: | HIOSSEN Inc. |
| - Address: | 85 Ben Fairless Dr. Fairless Hills, PA 19030 |
| - Contact: | DAVID KIM |
| - Phone: | 267 759 7031 |
-
- Device:
| Trade or (Proprietary) Name: | ET US SS Prosthetic system |
|---|---|
| Common or Usual Name: | Dental Abutment |
| Classification Name: | Endosseous dental implant abutment |
| Regulation Number: | 21CFR872.3630 |
| Device Classification: | Class II |
| Product Code: | NHA |
-
- Predicate Device:
Primary Predicate K062030 US System, OSSTEM IMPLANT CO.,LTD
- Predicate Device:
Reference Predicates
K121585 TS Implant System, OSSTEM IMPLANT CO.,LTD K100245 HS, HG Prosthetic System, OSSTEM IMPLANT CO.,LTD K130662 ET Prosthetic System, OSSTEM IMPLANT CO.,LTD K062051 SS System, OSSTEM IMPLANT CO.,LTD K073247 US.SS.GS System, OSSTEM IMPLANT CO.,LTD K121843 NP Cast Abutment System, OSSTEM IMPLANT CO.,LTD K081575 HU.HS.HG Prosthetic System, OSSTEM IMPLANT CO.,LTD K 132067 Multi Angled Abutment with carrier, OSSTEM IMPLANT CO.,LTD
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66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
4. Description:
The ET US SS Prosthetic system is intended for use as an aid in prosthetic restoration. It is consisted of abutments, components and abutment screws.
The ET US SS Prosthetic system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
The ET US SS Prosthetic system is substantially equivalent in design, function and intended use to the Predicate Devices as above.
| Item | Content | |
|---|---|---|
| Quick TemporaryAbutment | Description | Used temporary until final prosthesis is made to maintainesthetic appearance.Quick Temporary Abutment Set is consisted of QuickTemporary Abutment and Ti Screw. |
| Material | Titanium Alloy + Plastic (Polyetherethereketone) | |
| Diameter (mm) | 4, 4.5 | |
| Height (mm) | 13.9, 14.3, 14.5, 14.6, 17.4, 17.8, 18.0, 18.1 | |
| Multi Abutment | Description | Used for edentulous mandible or maxilla.Usually use to make full denture.Screw Retained Restoration.Used in screw type prosthetics in multiple cases.Multi Abutment Set is consisted of Multi Abutment andMulti Abutment Carrier. |
| Material | Titanium Alloy (TiN Coating) | |
| Diameter (mm) | 4.8 | |
| Height (mm) | 8.3, 8.7, 9.3 9.7, 10.3, 10.7, 11.3, 11.7, 12.3, 12.7 |
ET System
SS System
| Item | Content |
|---|---|
| Solid Abutment | DescriptionUsed in producing ordinary cement-retained prosthetics.Solid Abutment Set is consisted of Solid Abutment andSolid Protect Cap. |
| MaterialTitanium Alloy (ASTM F 136) | |
| Diameter (mm)3.5, 4.3 | |
| Height (mm)9.5, 9.8, 11, 11.3, 12.5, 12.8 | |
| Solid Protect Cap | DescriptionUsed to protect Solid abutments in the oral cavity. |
| MaterialPolymer (Polycarbonate) | |
| Diameter (mm)5.3, 6.02 | |
| Excellent Solid Abutment | DescriptionUsed in producing cement-retained prosthetics.Excellent Solid Abutment Set is consisted of ExcellentSolid Abutment and Solid Protect Cap. |
| MaterialTitanium Alloy (ASTM F 136) | |
| Diameter (mm)4.3, 5.29 |
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Image /page/5/Picture/0 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is written in a bold, sans-serif font in orange color. Below the word "OSSTEM", the word "IMPLANT" is written in a smaller, sans-serif font in gray color. 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 51 850-4341 www.osstem.com
| Height (mm) | 9.5, 9.7, 11, 11.2, 12.5, 12.7 | |
|---|---|---|
| Excellent SolidProtect Cap | Description | Used to protect Excellent Solid Abutments in the oral cavity. |
| Material | Polymer (Polycarbonate) | |
| Diameter (mm) | 5.3, 6.6 | |
| ComOcta Abutment | Description | Used for making general cement-type prosthesis.ComOcta Abutment is consisted of ComOcta Abutment and Ti Screw. |
| Material | Titanium Alloy (ASTM F 136) | |
| Diameter (mm) | 4.3, 5.26 | |
| Height (mm) | 6.53, 6.55, 6.88, 6.90, 8.03, 8.05, 8.38, 8.40, 9.53, 9.55,9.88, 9.90 | |
| ComOcta Plus Abutment | Description | Used for making general cement-type prosthesis and used when there is deep gingiva or a fixture is to be deeply inserted.Gold coloring on gingiva region is for aesthetics.ComOcta Plus Abutment Set is consisted of ComOcta Plus Abutment and Ti Screw. |
| Material | Titanium Alloy (ASTM F 136) | |
| Diameter (mm) | 4.8, 6.0 | |
| Height (mm) | 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10 | |
| ComOcta AngledAbutment | Description | Used for prosthetic restoration and path adjustment of prosthesis in case of 15° and 20° axial angle.ComOcta Angled Abutment Set is consisted of ComOcta Angled Abutment and Ti Screw. |
| Material | Titanium Alloy (ASTM F 136) | |
| Diameter (mm) | 3.75, 4.3 | |
| Height (mm) | 5.5, 6.7 | |
| ComOcta Retraction Cap | Description | Used to protect ComOcta abutments in the oral cavity |
| Material | Polymer (PolyOxy Methylene) | |
| Diameter (mm) | 6.4, 7.7 |
US System
| Item | Content | |
|---|---|---|
| Cover Screw | DescriptionMaterialDiameter (mm)Height (mm) | Used to protect other substances from ingressing into the fixture after the sugical operation.Titanium (ASTM F 67)3.7, 4.3, 5.2, 5.35.9 |
| Healing Abutment | DescriptionMaterialDiameter (mm)Height (mm) | Used to form the appropriate gingival shape after the second surgery.Titanium (ASTM F 67)4, 5, 6, 77.9, 8.9, 9.9, 11.4, 12.9 |
| Cemented Abutment | DescriptionMaterialDiameter (mm) | Used for making general cement-type prosthesis.Titanium Alloy (ASTM F 136)4.0, 4.1, 5.0, 5.1, 6.0, 7.0 |
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Image /page/6/Picture/0 description: The image contains the logo for Osstem Implant. The logo is in orange and consists of the word "OSSTEM" in a bold, sans-serif font, with the word "IMPLANT" in a smaller, lighter font underneath. The logo is simple and modern, and the orange color is eye-catching.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
| Height (mm) | 5.0, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0, 11.0 | |
|---|---|---|
| Ti Screw | Description | Used to connect abutment with fixture. |
| Material | Titanium Alloy (ASTM F 136) | |
| Diameter (mm) | 2.3, 2.9, 3.2 | |
| Height (mm) | 8.0, 8.2 | |
| US Multi AngledAbutment | Description | If a few number of fixture were implanted in mandibularbone for making full denture, some of fixture path shouldbe leaned. In that case, US Multi Angled Abutment is usedto adjust path of prosthesis in case of 17 and 30° axialangle.US Multi Angled Abutment Set is consisted of US MultiAngled Abutment, Ti Screw, and Abutment Carrier. |
| Material | Titanium Alloy (ASTM F 136) | |
| Diameter (mm) | 3.4, 4.0, 4.1 | |
| Height (mm) | 3.97, 3.98, 4.28, 4.77, 4.78, 5.28, 5.47, 6.28 | |
| Ti Screw | Description | Used to connect abutment with fixture. |
| Material | Titanium Alloy (ASTM F 136) | |
| Diameter (mm) | 2.2, 2.3 | |
| Height (mm) | 4.9, 5.55 | |
| Esthetic-low Abutment | Description | Used in producing screw-retained aesthetic prosthetics.Structure producing prosthetics in cylinder after attachingabutment in the oral cavity.Esthetic-low Abutment Set is consisted of Esthetic-lowAbutment and Esthetic-low Abutment Screw. |
| Material | Titanium (ASTM F67) | |
| Diameter (mm) | 4.8, 5.5 | |
| Height (mm) | 2.1, 2.2, 3.0, 3.1, 4.0, 4.1, 5.0, 5.1 | |
| Esthetic-low AbutmentScrew | Description | Used to connect Esthetic-low abutment with fixture. |
| Material | Titanium (ASTM F67) | |
| Diameter (mm) | 3.1, 3.6 | |
| Height (mm) | 7.8, 7.9, 8.8, 8.9, 9.8, 9.9, 10.8, 10.9 | |
| Esthetic-low TemporaryCylinder | Description | Used in producing temporary prosthetics.Esthetic-low Temporary Cylinder is consisted of Esthetic-low Temporary Cylinder and Ti Screw. |
| Material | Titanium (ASTM F 67) | |
| Diameter (mm) | 4.8, 5.5 | |
| Height (mm) | 12.0 | |
| O-ring Abutment | Description | Used in creating stud type overdenture prosthetics. |
| Material | Titanium Alloy | |
| Diameter (mm) | 5.0, 5.6 | |
| Height (mm) | 2.0, 3.0, 4.0, 5.0, 6.0 |
5. Indications for Use:
ET System
The HIOSSEN Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.
US/ SS System
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.
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Image /page/7/Picture/0 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 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 51 850-4341 www.osstem.com
6. Substantial Equivalence Matrix:
| Proposed Device | Primary Predicate Device | Reference Predicate | |
|---|---|---|---|
| 510K | - | K062030 | K130662 |
| Indications forUse | ET SystemThe HIOSSENProsthetic system isintended for use with adental implant toprovide support forprosthetic restorationssuch as crowns, bridges,or over-dentures.US/ SS SystemThe OSSTEM Prostheticsystem is intended for usewith a dental implant toprovide support forprosthetic restorationssuch as crowns, bridges,or over-dentures. | Us system and ssii mini areintended for use in partiallyor fully edentulous mandiblesand maxillae, in support ofsingle or multiple-unitrestorations including:cemented retained, screwretained, or overdenturerestorations, and terminal orintermediate abutmentsupport for fixed bridgework.Us system is for two stagesurgical procedures. It is notfor one stage or immediateload. Ssii mini is for one andtwo stage surgical procedures.It is not for immediate load. | ET ProstheticSystems is intendedfor use with a dentalimplant to providesupport for prostheticrestorations such ascrowns, bridges, oroverdentures. |
The Indications for Use of the submission device differs from the primary predicate as in that the submission Indications are specific to the sub-set of devices, that is abutments, which have been included in the current submission. The primary predicate contains devices for a complete implant system and the Indications reflects this. Since the current submission is a sub-set of devices included in the primary predicate, the modification of the Indications to a sub-set of the primary predicate Indications is also appropriate. The Indications for the submission device are also identical to a reference predicate which only contains a similar abutment sub-set of devices.
Subtantial Equivalence Matrixes for each specific device are provided as shown below.
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| 510K | - | K121843 |
| Material | Titanium AlloyPEEK | Titanium AlloyPEEK |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description(Intended for use) | Used to make temporaryprosthesis | Used to make temporaryprosthesis |
| Principles ofOperation | Quick Temporary Abutment isused in producing temporary | Quick Temporary Abutment isused in producing temporary |
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Image /page/8/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, gray font.
| prosthetics for immediate loadingUpper part is made with plastic(PEEK) for easy altering/removingwhen make temporary prosthetics | prosthetics for immediate loadingUpper part is made with plastic(PEEK) for easy altering/removingwhen make temporary prosthetics | |
|---|---|---|
| Dimension(Diameter) | 4mm, 4.5mm | 4.5mm, 5.5mm |
| Connection | Internal Hex Connection | Internal Hex Connection |
| Characteristic | Cement retained restoration.Capable of easily altering/removingshape of plastic material.Abutment + Screw | Cement retained restoration.Capable of easilyaltering/removing shape of plasticmaterial.Abutment + Screw |
| Design | Image: Abutment with screw | Image: Abutment with screw |
| SE | Difference:Shape of upper part (Plastic part) is different from predicate, QuickTemporary AbutmentIt is designed to be used when limitations in space (narrow space )The Quick Temporary Abutment had been cleared with K121585 but itis being sumitted to add revised shape therefore Quick TemporaryAbutmet and Predicate devices have same principles of operation,function, material, Connection structure, charateristic and intended use |
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| 510K | - | K062051 |
| Material | Titanium Alloy | Titanium Alloy |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description(Intended for use) | Used to make Cement-retainedprosthesis | Used to make Cement-retainedprosthesis |
| Principles ofoperation | As general one body cementretained restoration, it is connectedwith fixture and cemented crownon the abutment | As general one body cementretained restoration, it is connectedwith fixture and cemented crownon the abutment |
| Dimension(Height) | 9.5mm, 9.8mm, 11mm, 11.3mm,12.5mm, 12.8mm | 9.5mm, 9.8mm, 11mm, 11.3mm,12.5mm |
| Connection | Internal Octa Connection | Internal Octa Connection |
| Characteristic | Cement retained restorationAbutment + Protect Cap | Cement retained restorationAbutment + Protect Cap |
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Image /page/9/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, and the word "IMPLANT" is written in gray below it. The font is sans-serif and appears to be bolded.
| Design | Image: dental abutment | Image: dental abutment |
|---|---|---|
| Difference:New dimension is added. | ||
| S E | The Solid Abutment had been cleared with K062051, but it is beingsumitted to add a new dimension. Therefore, Solid Abutment andPredicate devices have same principles of operation, function, material,connection structure, charateristic and intended use. |
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| Solid Protect Cap | Solid Protect Cap | |
| 510K | K062051 | |
| Material | Polymer (Polycarbonate) | Polymer (Polycarbonate) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description(Intended for use) | Used to protect Solid Abutment inthe oral cavity | Used to protect Solid Abutment inthe oral cavity |
| Principles ofoperation | Solid Protect Cap is connectedwith Solid Abutment to protect inthe oral cavity and minimizeforeign body sensation by thepatient | Solid Protect Cap is connectedwith Solid Abutment to protect inthe oral cavity and minimizeforeign body sensation by thepatient |
| Dimension(diameter) | 5.3mm, 6.02mm | 5.5mm, 6.7mm |
| Characteristic | Protect abutment in the oral cavity | Protect abutment in the oral cavity |
| Design | Image: Proposed Device Design | Image: Predicate Device Design |
| SE | Difference:New dimension is added and shape is changed.The Solid Protect Cap had been cleared with K062051, but it is beingsumitted to add a new dimension added and its shape changed.Therefore, Solid Protect Cap and Predicate devices have same principlesof operation, function, material, charateristic and intended use. |
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in large, bold, orange letters. Below it, the word "IMPLANT" is in smaller, gray letters. The logo is simple and modern.
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| 510K | - | K062051 |
| Material | Titanium Alloy (ASTM F 136) | Titanium Alloy (ASTM F 136) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description(Intended for use) | Used to make Cement-retainedprosthesis | Used to make Cement-retainedprosthesis |
| Principles ofoperation | As general one body cementretained restoration, it is connectedwith fixture and cemented crownon the abutment | As general one body cementretained restoration, it is connectedwith fixture and cemented crownon the abutment |
| Dimension(Height) | 9.5mm, 9.7mm, 11mm, 11.2mm,12.5mm, 12.7mm | 9.5mm, 9.7mm, 11mm, 11.2mm,12.5mm |
| Connection | Internal Octa Connection | Internal Octa Connection |
| Characteristic | Cement retained restorationAbutment + Protect Cap | Cement retained restorationAbutment + Protect Cap |
| Design | Image: Proposed Device Design | Image: Predicate Device Design |
| SE | Difference:New dimension is added.The Excellent Solid Abutment had been cleared with K062051, but it isbeing sumitted to add a new dimension. Therefore, Solid Abutment andPredicate devices have same principles of operation, function, material,connection structure, charateristic and intended use. |
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| Excellent Solid Protect Cap | Excellent Solid Protect Cap | |
| 510K | - | K062051 |
| Material | Polymer (Polycarbonate) | Polymer (Polycarbonate) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description(Intended for use) | Used to protect Excellent SolidAbutment in the oral cavity | Used to protect Excellent SolidAbutment in the oral cavity |
| Principles ofoperation | Excellent Solid Protect Cap isconnected with Solid Abutment toprotect in the oral cavity andminimize foreign body sensationby the patient | Excellent Solid Protect Cap isconnected with Solid Abutment toprotect in the oral cavity andminimize foreign body sensationby the patient |
| Dimension(Height) | 6.35mm, 7.85mm, 9.35mm,9.65mm | 6.35mm, 7.85mm, 9.35mm |
{11}------------------------------------------------
I M P L A N 1
| Characteristic | Protect abutment in the oral cavity | Protect abutment in the oral cavity |
|---|---|---|
| Design | Image: Protect abutment in the oral cavity | Image: Protect abutment in the oral cavity |
| S E | Difference:New dimension is added.The Excellent Solid Protect Cap had been cleared with K062051, but itis being sumitted to add a new dimension. Therefore, Solid Protect Capand Predicate devices have same principles of operation, function,material, charateristic and intended use. |
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| 510K | ComOcta Abutment | K073247 |
| Material | Titanium Alloy (ASTM F 136) | Titanium Alloy (ASTM F 136) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description(Intended for use) | Used to make Cement-retainedprosthesis | Used to make Cement-retainedprosthesis |
| Principles ofoperation | As general cement retainedrestoration, it is connected withfixture and cemented crown on theabutment | As general cement retainedrestoration, it is connected withfixture and cemented crown on theabutment |
| Dimension(Height) | 6.53mm, 6.55mm, 6.88mm,6.90mm, 8.03mm, 8.05mm,8.38mm, 8.40mm, 9.53mm,9.55mm, 9.88mm, 9.90mm | 6.53mm, 6.55mm, 6.88mm,6.90mm, 8.03mm, 8.05mm,8.38mm, 8.40mm, 9.53mm,9.55mm |
| Connection | Internal Octa Connection | Internal Octa Connection |
| Characteristic | Cement retained restorationAbutment + Screw | Cement retained restorationAbutment + Screw |
| Design | Image: ComOcta Abutment design | Image: ComOcta Abutment design |
| SE | Difference:New dimensions are added.The ComOcta Abutment had been cleared with K062051, but it is beingsumitted to add new dimension. Therefore, ComOcta Abutment and |
{12}------------------------------------------------
Image /page/12/Picture/0 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.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
Predicate devices have same principles of operation, function, material, connection structure, charateristic and intended use.
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| ComOcta Plus Abutment | ComOcta Plus Abutment | |
| 510K | - | K073247 |
| Material | Titanium Alloy (ASTM F 136) | Titanium Alloy (ASTM F 136) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description(Intended for use) | Used to make Cement-retainedprosthesisUsed when there is deep gingiva ora fixture is to be deeply inserted | Used to make Cement-retainedprosthesisUsed when there is deep gingiva ora fixture is to be deeply inserted |
| Principles ofoperation | As general cement retainedrestoration, it is connected withfixture and cemented crown on theabutment | As general cement retainedrestoration, it is connected withfixture and cemented crown on theabutment |
| Dimension(Height) | 6.5mm, 7mm, 7.5mm, 8mm,8.5mm, 9mm, 9.5mm, 10mm | 7.5mm, 8mm, 9.5mm, 10mm |
| Connection | Internal Octa Connection | Internal Octa Connection |
| Characteristic | Cement retained restorationAbutment + ScrewGold coloring on gingiva regionfor asthetics | Cement retained restorationAbutment + ScrewGold coloring on gingiva regionfor asthetics |
| Design | Image: abutment | Image: abutment |
| SE | Difference:New dimensions and Non-Octa type abutments are added.The ComOcta Plus Abutment had been cleared with K073247, but it isbeing sumitted to add new dimensions and Non-Octa type abutments.Therefore, ComOcta Plus Abutment and Predicate devices have sameprinciples of operation, function, material, charateristic and intended use. |
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| ComOcta Angled Abutment | ComOcta Angled Abutment | |
| 510K | - | K073247 |
| Material | Titanium Alloy (ASTM F 136) | Titanium Alloy (ASTM F 136) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description | Used for prosthetic restoration | Used for prosthetic restoration |
{13}------------------------------------------------
MPLAN7
| (Intended for use) | Used for the path adjustment ofprosthesis in case of 15° and 20°axial angle | Used for the path adjustment ofprosthesis in case of 15° and 20°axial angle |
|---|---|---|
| Principles ofoperation | As general cement retainedrestoration, it is connected withfixture and cemented crown on theabutmentComOcta Angled Abutment has15° and 20° axial angle for pathadjustment of prosthesis | As general type cement retainedrestoration, it is connected withfixture and cemented crown on theabutmentComOcta Angled Abutment has15° and 20° axial angle for pathadjustment of prosthesis |
| Dimension(diameter) | 3.75mm, 4.3mm | 3.75mm, 4.3mm |
| Connection | Internal Octa Connection | Internal Octa Connection |
| Characteristic | Cement retained restorationAbutment + Screw | Cement retained restorationAbutment + Screw |
| Design | Image: Design 1 | Image: Design 2 |
| SE | Difference:Non-Octa type abutments are added.The ComOcta Angled Abutment had been cleared with K073247, but itis being sumitted to add Non-Octa type. Therefore, ComOcta AngledAbutment and Predicate devices have same principles of operation,function, material, charateristic and intended use. |
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| 510K | - | K062030 |
| Material | Titanium (ASTM F 67) | Titanium (ASTM F 67) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description(Intended for use) | Used to protect other substancesfrom ingressing into the fixtureafter the surgical operation | Used to protect other substancesfrom ingressing into the fixtureafter the surgical operation |
| Principles ofoperation | Cover Screw is connected withimplanted fixture to protect othersubstances from ingressing into thefixture after the surgical operation | Cover Screw is connected withimplanted fixture to protect othersubstances from ingressing into thefixture after the surgical operation |
| Dimension(diameter) | 3.7mm, 4.3mm, 5.2mm, 5.3mm | 3.7mm, 4.3mm, 5.3mm |
| Characteristic | Used to protect other substancesfrom ingressing into the fixture | Used to protect other substancesfrom ingressing into the fixture |
{14}------------------------------------------------
OSSTEM
IMPLANT
| Design | Image: screw | Image: screw |
|---|---|---|
| S E | Difference:New dimension is added.The Cover Screw had been cleared with K062030, but it is beingsumitted to add a new dimensio. Therefore, Cover Screw and Predicatedevices have same principles of operation, function, material,charateristic and intended use. |
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| Healing Abutment | Healing Abutment | |
| 510K | K062030 | |
| Material | Titanium (ASTM F 67) | Titanium (ASTM F 67) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description(Intended for use) | Used to form the appropriategingival shape after the secondssurgery | Used to form the appropriategingival shape after the secondssurgery |
| Principles ofoperation | Healing Abutment is connectedwith implanted fixture to form theappropriate gingival shape afterthe seconds surgery | Healing Abutment is connectedwith implanted fixture to form theappropriate gingival shape after theseconds surgery |
| Dimension(diameter) | 4mm, 4.13mm, 5mm, 5.1mm,5.13mm, 6mm, 7mm | 4mm, 5mm, 6mm, 7mm |
| Characteristic | Used to protect other substancesfrom ingressing into the fixture | Used to protect other substancesfrom ingressing into the fixture |
| Design | Image: Proposed Device Design | Image: Predicate Device Design |
| SE | Difference:New dimensions and shape are added.The Healing Abutment had been cleared with K062030, but it is beingsumitted to add new dimensions and shape. Therefore, HealingAbutment and Predicate devices have same principles of operation,function, material, charateristic and intended use. |
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in large, bold, orange letters. Below it, the word "IMPLANT" is in smaller, gray letters. The logo is simple and modern.
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| 510K | - | K073247 |
| Material | Titanium Alloy (ASTM F 136) | Titanium Alloy (ASTM F 136) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description(Intended for use) | Used to make Cement-retainedprosthesis | Used to make Cement-retainedprosthesis |
| Principles ofoperation | As general cement retainedrestoration, it is connected withfixture and cemented crown on theabutment | As general cement retainedrestoration, it is connected withfixture and cemented crown on theabutment |
| Dimension(diameter) | 4.0mm, 4.1mm, 5.0mm, 5.1mm,6.0mm, 7.0mm | 4.0mm, 5.0mm, 6.0mm, 7.0mm |
| Connection | External Hex Connection | External Hex Connection |
| Characteristic | Cement retained restorationAbutment + Screw | Cement retained restorationAbutment + Screw |
| Design | Image: Proposed Device Design | Image: Predicate Device Design |
| SE | Difference:New dimension are added.The Cemented Abutment had been cleared with K073247, but it is beingsumitted to add a new dimension. Therefore, Cemented Abutment andPredicate devices have same principles of operation, function, material,connection structure, charateristic and intended use. |
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| Ti Screw | Ti Screw | |
| 510K | - | K062030 |
| Material | Titanium Alloy (ASTM F 136) | Titanium Alloy (ASTM F 136) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description (Intended for use) | Used to connect abutment with fixture | Used to connect abutment with fixture |
| Principles of operation | Connect an abutment with fixture using by screw | Connect an abutment with fixture using by screw |
| Dimension (diameter) | 2.3mm, 2.9mm, 3.2mm | 2.5mm, 2.6mm, 2.9mm, 3.2mm |
| Characteristic | Connect an abutment with fixture | Connect an abutment with fixture |
{16}------------------------------------------------
0
| Design | Image: Screw | Image: Screw |
|---|---|---|
| Difference:New dimension is added. | ||
| S E | The Ti Screw had been cleared with K062030, but it is being sumitted toadd new code for new dimension added. Therefore, Ti Screw andPredicate devices have same principles of operation, function, material,charateristic and intended use. |
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| Esthetic-low Abutment | Esthetic-low Abutment | |
| 510K | - | K062030 |
| Material | Titanium (ASTM F67) | Titanium (ASTM F67) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description(Intended for use) | Used in producing screw-retainedaesthetic prostheticsStructure producing prosthetics incylinder after attaching abutmentin the oral cavity | Used in producing screw-retainedaesthetic prostheticsStructure producing prosthetics incylinder after attaching abutmentin the oral cavity |
| principles ofoperation | Esthetic-low abutment isconnected to implanted fixture andupper part is connected to cylinderEsthetic-low abutment usescylinder screw to fasten screw-retained type prosthesis | Esthetic-low abutment isconnected to implanted fixture andupper part is connected to cylinderEsthetic-low abutment usescylinder screw to fasten screw-retained type prosthesis |
| Dimension(Diameter ofConnection) | 2.41mm, 2.71mm, 3.41mm | 2.71mm, 3.41mm |
| Connection | External Hex Connection | External Hex Connection |
| Characteristic | Screw retained prosthesis | Screw retained prosthesis |
| Design | Image: Design of Esthetic-low Abutment | Image: Design of Esthetic-low Abutment |
| SE | Difference:New dimensions are added.The Esthetic-low Abutment had been cleared with K062030, but it isbeing sumitted to add new dimensions. Therefore, Esthetic-lowAbutment and Predicate devices have same principles of operation |
{17}------------------------------------------------
Image /page/17/Picture/1 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 51 850-4341 www.osstem.com
function, material, connection structure, charateristic and intended use.
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| O-ring Abutment | O-ring Abutment | O-ring Abutment |
| 510K | - | K062030 |
| Material | Titanium Alloy | Titanium Alloy |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description(Intended for use) | Used in creating stud typeoverdenture prosthetics | Used in creating stud typeoverdenture prosthetics |
| principles ofoperation | O-ring abutment is generallyapplied to prosthetic procedurefor overdentures.Its O-ring attachment retainedabutment, connected to fixture,and then acts as the malecounterpart | O-ring abutment is generally appliedto prosthetic procedure foroverdentures.Its O-ring attachment retainedabutment, connected to fixture, andthen acts as the male counterpart |
| Dimension(diameter) | 5.0mm, 5.6mm | 5.0mm |
| Connection | External Hex Connection | External Hex Connection |
| Characteristic | Stud type overdenture prosthesis | Stud type overdenture prosthesis |
| Design | Image: Proposed Device Design | Image: Predicate Device Design |
| S E | Difference:New dimensions are added.The O-ring Abutment had been cleared with K062030, but it is beingsubmitted to add new dimensions added. Therefore, O-ring Abutmentand Predicate devices have same principles of operation, function,material, connection structure, characteristic and intended use. |
| Proposed Device | Predicate Device | |
|---|---|---|
| Part Name | ComOcta Retraction Cap | Excellent Solid Retraction cap |
| 510K | - | K100245 |
| Material | Polymer (POM) | Polymer (POM) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
{18}------------------------------------------------
Image /page/18/Picture/0 description: The image shows the text "Section 003" in a clear, sans-serif font. The text is presented in a warm, orange color, which makes it stand out against the white background. The words are arranged on a single line, with "Section" appearing first, followed by a space, and then the number "003".
Image /page/18/Picture/1 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 small circle above the "M" in "OSSTEM".
| Description(Intended for use) | Used to protect ComOctaabutments in the oral cavity andminimize foreign bodysensation by the patientAccurate margin impressionfunction when takingimpression directly from aComOcta abutment | Used for the protection of theExcellent solid abutment on thepatient's discomfort. |
|---|---|---|
| Dimension(Diameter) | 6.4, 7.7mm | 6.4, 7.7mm |
| Design | Image: ComOcta Retraction Cap | Image: Excellent Solid Retraction Cap |
| Principles ofoperation | ComOcta Retraction Cap istemporary connected withComOcta abutment forminimize foreign bodysensation by the patient andaccurate margin impressionfunction when takingimpression directly from aComOcta abutment | Excellent Solid Retraction Capis temporary connected withExcellent Solid abutment forminimize foreign bodysensation by the patient andaccurate margin impressionfunction when takingimpression directly from aExcellent solid abutment |
| SE | DifferentOnly connection shape is different because of difference ofcompatible abutment post shape | |
| ComOcta Retraction Cap is elementally the same to ExcellentSolid Retraction cap (K100245) Such as principles of operation.function, material, charateristic and intended use but connectionshape is different depend on abutment shape |
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| 510K | - | K132067 |
| Material | titanium alloy (ASTM F 136) | titanium alloy (ASTM F 136) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description(Intended for use) | If a few number of fixture wereimplanted in mandibular bonefor making full denture, someof fixture path should be leaned.In that case, US Multi Angled | If a few number of fixture wereimplanted in mandibular bonefor making full denture, someof fixture path should be leaned.In that case, Multi Angled |
{19}------------------------------------------------
Image /page/19/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with the word "IMPLANT" written in gray underneath. The logo is simple and modern, and it is likely used to promote the company's dental implant products.
Section 003
| Abutment is used to adjust pathof prosthesis. | Abutment is used to adjust pathof prosthesis. | |
|---|---|---|
| Dimension(Diameter) | 3.4, 4.0, 4.1mm | 2.84, 2.88, 3.39, 4.9mm |
| Connection | external Hex Connection | Internal Hex Connection |
| Characteristic | Screw retained restoration.Connected with CylinderAbutment + Screw | Screw retained restoration.Connected with CylinderAbutment + Screw |
| Design | Image: Angled abutment | Image: Angled abutment with cylindrical base |
| Principles ofoperation | US Multi Angled Abutment isconnected implanted fixture andupper part is connected cylinder | Multi Angled Abutment isconnected implanted fixture andupper part is connected cylinder |
| SE | Difference:US Multi Angled Abutment has different connection structureconnected implanted fixture from Predicate device, Multi AngledAbutment (K132067) because US Multi Angled Abutment isconnected with external Hex Connection fixture and Multi AngledAbutment is connected with Internal Hex Connection fixtureBut elementally US Multi Angled Abutment and Predicate deviceshave same principles of operation, function, material, Connectionstructure connected with cylinder, charateristic and intended use |
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| Ti Screw | Ti Screw | |
| 510K | - | K062030 |
| Material | Titanium Alloy (ASTM F 136) | Titanium Alloy (ASTM F 136) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description(Intended for use) | Used to connect abutment withfixture | Used to connect abutment withfixture |
| Principles ofOperation | Connect an abutment withfixture using by screw | Connect an abutment with fixtureusing by screw |
| Dimension(Diameter) | 2.2mm, 2.3mm | 2.5mm, 2.6mm, 2.9mm, 3.2mm |
| Characteristic | Connect an abutment withfixture using by screw | Connect an abutment with fixture |
{20}------------------------------------------------
Section 003
Image /page/20/Picture/1 description: The image contains the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, gray, sans-serif font. The logo is simple and modern.
OSSTEM Implant Co., Ltd.
| Design | Image: screw design 1 | Image: screw design 2 |
|---|---|---|
| SE | Difference:Dimensions are different between proposed device and predicate device.But elementally Ti screw and Predicate devices have sameprinciples of operation, function, material, characteristic andintended use. |
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| 510K | - | K062030 |
| Material | Titanium (ASTM F 67) | Titanium (ASTM F 67) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description(Intended for use) | Esthetic-low TemporaryCylinder is used for prostheticrestoration. This is used tomake temporary prosthesis anddesigned to minimizedindication constraints | Esthetic-low TemporaryCylinder is used for prostheticrestoration. This is used tomake temporary prosthesis anddesigned to minimizedindication constraints |
| Dimension(Diameter) | 4.8, 5.5mm | 4.8, 5.5mm |
| Connection | external Hex Connection | external Hex Connection |
| Characteristic | Cement retained restoration.Abutment + Screw | Cement retained restoration.Abutment + Screw |
| Principles ofoperation | Esthetic-low TemporaryCylinder is used in producingtemporary prosthetics that isconnected with Esthetic-lowAbutment for immediateloading | Esthetic-low TemporaryCylinder is used in producingtemporary prosthetics that isconnected with Esthetic-lowAbutment for immediateloading |
| Design | Image: Proposed Device Design | Image: Predicate Device Design |
{21}------------------------------------------------
Section 003
Image /page/21/Picture/1 description: The image contains the logo for OSSTEM IMPLANT. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern.
)SSTEM Implant Co., Ltd.
6-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
| Difference:Post shape of subject device is different with predicateAddition of new post shape | |
|---|---|
| SE | Esthetic-low Temporary Cylinder is exactly same with predicateddevice, Esthetic-low Temporary Cylinder in principles ofoperation, function, material, Connection structure, charateristicand intended use |
7. Summary of nonclinical testing:
The following nonclinical testing data were provided or relied upon in support of the substantial equivalence determination.
Biocompatibility
Material in use, manufacturing process, surface treatment, and sterilization method is same as the predicates, US System, OSSTEM IMPLANT CO., LTD., K062030; TS Implant System, OSSTEM IMPLANT CO., LTD., K121585; HS, HG Prosthetic System, OSSTEM IMPLANT CO., LTD., K100245; ET Prosthetic System, OSSTEM IMPLANT CO., LTD., K130662; SS System, OSSTEM IMPLANT CO., LTD., K062051; US, SS, GS System, OSSTEM IMPLANT CO., LTD., K073247; NP Cast Abutment System, OSSTEM IMPLANT CO., LTD., K121843; HU, HS, HG Prosthetic System, OSSTEM IMPLANT CO., LTD., K081575; and Multi Angled Abutment with carrier, OSSTEM IMPLANT CO., LTD., K132067. Therefore, no additional testing is required to support the biological safety of the subject devices.
Sterilization Validation
For Cover Screw and Healing Abutment, the test result is considered to be substantial equivalent to that of the predicate, GSII RBM Fixture of GS Fixture System, OSSTEM IMPLANT CO., LTD., K072896; therefore, no additional testing is required. Except for them, the rest are non-sterile devices and are conducted of steam sterilization validation according to ISO 17665-1:2006.
Fatigue Test
Fatigue testing was considered according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario.
-
- Summary of clinical testing:
No clinical studies are submitted.
- Summary of clinical testing:
-
- Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based
- Conclusions:
{22}------------------------------------------------
Image /page/22/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with the word "IMPLANT" written in gray underneath. The logo is simple and modern, and it is likely used to represent a company that manufactures or sells dental implants.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
on the information provided in this premarket notification OSSTEM CO., LTD. concludes that ET US SS Prosthetic system is substantially equivalent to the predicate devices as described herein.
§ 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.)