(343 days)
Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
• Link Abutment for CEREC
The Link Abutment for CEREC is titanium alloy abutments placed onto OSSTEM dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. CAD/CAM manufacturing/milling occurs at dental laboratories per the design limitations of the Sirona CEREC.
Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Osstem Abutment System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.
Osstem Abutment System is substantially equivalent in design, function and intended use to the predicate devices as above.
The document then lists various components of the system including Transfer Abutment, Angled Abutment, Link Abutment for Cerec, Temporary Abutment, Multi Angled Abutment, Multi NP-Cast Cylinder, Multi Combination Cylinder, Convertible Angled Cylinder, Stud Abutment, O-ring, O-ring Retainer Cap, Port Abutment, Port Angled Abutment, Port Angled Abutment Head, Port Male, Port Extended Male, Port Male Cap, Port Male Kit, Abutment Screw, Cylinder Screw, Esthetic-low Temporary Cylinder, and Temporary Cap (Narrow Ridge), along with their descriptions, materials, and dimensions.
The provided document is a 510(k) premarket notification for the Osstem Abutment System. It outlines how the device is considered substantially equivalent to already marketed predicate devices, rather than providing a performance study against specific acceptance criteria for a new AI/software device.
Therefore, many of the requested details, such as those related to AI/algorithm performance (e.g., test set sample size, expert ground truth establishment, MRMC studies, standalone performance), are not applicable to this type of submission. The document focuses on material properties, design, indications for use, and a comparison to predicate devices to establish substantial equivalence.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not present explicit acceptance criteria in the typical sense of performance metrics for an AI/software device (e.g., accuracy, sensitivity, specificity). Instead, substantial equivalence is claimed based on similarities in:
- Intended Use
- Technology (design principles)
- Material Composition
- Performance Characteristics (mechanical properties, biocompatibility, sterilization)
The performance is "reported" by demonstrating that the device is equivalent to known predicate devices through non-clinical testing (biocompatibility, sterilization validation, mechanical properties, specifically fatigue testing and retention testing). The document states: "Non-clinical testing data are submitted, referenced, or relied upon to demonstrate substantial equivalence."
| Acceptance Criteria (Demonstration of Substantial Equivalence to Predicates) | Reported Device Performance (as described in the 510(k)) |
|---|---|
| Biocompatibility | Evaluted following FDA Guidance Document ISO 10993-1 and ISO 10993 suite of standards. (Implies compliance, but no specific numerical results or pass/fail thresholds are provided in this summary.) |
| Sterilization Validation | Considered according to ISO 17665-1 (for non-sterile delivery). (Implies validation, but no specific numerical results or pass/fail thresholds are provided. Products are provided non-sterile, so this refers to validation of sterilization methods for the end-user.) |
| Mechanical Properties (Fatigue Testing) | Considered according to 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 worst-case scenario. (Implies testing was performed and passed, but no specific numerical results or pass/fail thresholds are provided.) |
| Mechanical Properties (Retention Testing for Dental Attachments) | Conducted. (Implies testing was performed and passed, but no specific numerical results or pass/fail thresholds are provided.) |
| Indications for Use | "Identical, with the exception of the addition to the Subject Indications for Use Statements language regarding the Link Abutment for CEREC. This language is identical to the Indications for Use Statement of the Reference Device being used for the Substantial Equivalence comparison for the Link Abutment for CEREC." (Demonstrated through comparison tables in Section 6). |
| Material Composition | "Identical" or "Within the range of the predicates" for most components. (Demonstrated through comparison tables in Section 6). |
| Design/Dimensions | "Identical" or "Similar" or "Within the range of the predicates" with explanations for minor differences and why they don't affect safety/effectiveness. (Demonstrated through comparison tables in Section 6). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided. The submission relies on non-clinical (laboratory) testing for mechanical properties and biocompatibility, as well as comparison to predicate devices, not on a clinical test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical test set or human expert review of "truth" data for diagnostic performance is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/software device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For mechanical testing, the "ground truth" would be established by the physical and mechanical properties of the materials and designs as measured in laboratory tests, and compared against established industry standards (ISO 14801) and FDA guidance for dental abutments. For biocompatibility, it's adherence to ISO 10993 standards. No clinical ground truth from patients is established or used for this 510(k) submission.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of device submission.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
July 12, 2019
Osstem Implant Co., Ltd. % Peter Lee QA/RA Manager Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030
Re: K182091
Trade/Device Name: Osstem Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 12, 2019 Received: June 13, 2019
Dear Peter Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality 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" also appearing in orange next to the company name. The contact information includes the company's address, telephone number (+82 51 850 2500), fax number (+82 51 861 4693), and website (www.osstem.com).
510(k) Number: K182091
Device Name: Osstem Abutment System
Indication for Use:
Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
· Link Abutment for CEREC
The Link Abutment for CEREC is titanium alloy abutments placed onto OSSTEM dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. CAD/CAM manufacturing/milling occurs at dental laboratories per the design limitations of the Sirona CEREC.
X Prescription Use (21 CFR 801 Subpart D) Over-The Counter Use (21 CFR 801 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 51 861 4693 www.osstem.com
510(k) Summary
K182091
Date: July 12, 2019
1. Administrative Information
| Submitter | OSSTEM IMPLANT Co., Ltd. |
|---|---|
| - Address | 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, 612-070, Korea |
| - Contact | Ms. Jungmin Yoo |
| - Phone | +82-51-850-2575 |
| Correspondent | HIOSSEN Inc. |
| - Address | 85 Ben Fairless Dr. Fairless Hills, PA 19030 |
| - Contact | Mr. Peter Lee |
| - Phone | 267-759-7031 |
2. Device Name and Classification
| Trade or (Propreitary) Name | Osstem Abutment System |
|---|---|
| Common or Usual Name | Dental Abutment |
| Classification Name | Endosseous dental implant abutment |
| Regulation Number | 21 CFR 872.3630 |
| Device Classification | Class II |
| Product Code | NHA |
3. Predicate Device
| Primary Predicate | |
|---|---|
| K161689 | OSSTEM Implant System - Abutment, Osstem Implant Co., Ltd. |
| Reference Predicates | |
| K160670 | ET US SS Prosthetic System |
| K160519 | Link Abutment for CEREC, Osstem Implant Co., Ltd. |
| K150295 | LOCATOR RTx, Zest Anchors, Inc. |
| K140507 | Hiossen Prosthetic System, Osstem Implant Co., Ltd. |
| K132067 | Multi Angled Abutment System, Osstem Implant Co., Ltd. |
| K120847 | ET/SS Implant System, Osstem Implant Co., Ltd. |
| K080594 | MS System (Narrow Ridge), Osstem Implant Co., Ltd. |
| K063861 | GS System, Osstem Implant Co., Ltd. |
| K062030 | US System, Osstem Implant Co., Ltd. |
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4. Indication for Use
Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
· Link Abutment for CEREC
The Link Abutment for CEREC is titanium alloy abutments placed onto OSSTEM dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. CAD/CAM manufacturing/milling occurs at dental laboratories per the design limitations of the Sirona CEREC.
5. Device Description
| Manufacturer | Model Name | Connection | Diameter (mm) |
|---|---|---|---|
| Osstem Implant Co., Ltd. | TS SA Fixture | Internal Hex | 3.2, 3.5, 3.75, 3.77, 4.2, 4.25, 4.4, 4.6, 4.63,4.65, 4.8, 4.9, 5.05, 5.08, 5.1, 5.25, 5.92, 5.95,6, 6.2, 6.8, 7.1 |
| SS SA Fixture | Internal Octa | 3.75, 4.1, 4.25, 4.45, 4.6, 4.9, 5, 5.05, 5.92,5.95, 5.96, 6, 6.8, 6.93 | |
| US SA Fixture | External Hex | 3.6, 4.2, 5.1, 5.2 | |
| MS SA Implant | Narrow Ridge | 2.5, 2.9 |
Osstem Abutment System is compatible with the following implant systems.
Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Osstem Abutment System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.
Osstem Abutment System is substantially equivalent in design, function and intended use to the predicate devices as above.
| Device | Content | |
|---|---|---|
| Transfer Abutment | Description Transfer Abutment is used for prosthetic restoration. It | |
| is used for making general cement-type prosthesis. | ||
| Material | Titanium Alloy (Ti-6Al-4V, ASTM F136) | |
| Diameter (mm) | 4.0, 4.6, 5.0, 6.0, 7.0 | |
| Post Height (mm) | 4.0, 5.5, 7.0 | |
| Description | Angled Abutment is used for prosthetic restoration. It is used for making general cement-type prosthesis. It is used when a prosthetic's path adjustment is necessary | |
| Angled Abutment | Material | Titanium Alloy (Ti-6Al-4V, ASTM F136) |
| Diameter (mm) | 4.0, 4.5, 5.0, 6.0 | |
| Post Height (mm) | 8 | |
| Angulation | 17° | |
| Link Abutment for Cerec | Description | Link Abutment for Cerec is used for customized prosthetic restoration. It is indicated for screw-retained single tooth or cement-retained single tooth and bridges restorations. It is compatible with the Sirona CEREC MC X and MC XL prosthetic milling system. |
| Material | Titanium Alloy (Ti-6Al-4V, ASTM F136) | |
| Diameter (mm) | 4.5 | |
| Post Height (mm) | 4.7 | |
| Temporary Abutment | Description | Temporary Abutment is used for prosthetic restoration. It is used temporarily to maintain esthetic appearance until final prosthesis is made. |
| Material | Titanium Gr.3 (ASTM F67) | |
| Diameter (mm) | 4.0, 4.5 | |
| G/H (mm) | 1.0, 3.0 | |
| Multi Angled Abutment | Description | If a few numbers of fixtures were implanted in mandibular bone for making full denture, some of fixture path should be leaned. Multi Angled Abutment is used to adjust path of prosthesis. |
| Material | Titanium Alloy (Ti-6Al-4V, ASTM F136) | |
| Diameter (mm) | 4.9 | |
| Height (mm) | 5, 5.1, 5.5, 5.6, 6, 6.1, 6.5, 6.6, 7.5, 7.6 | |
| Angulation | 17°, 30° | |
| Multi NP-Cast Cylinder | Description | Multi NP-Cast Cylinder is used for prosthetic restoration. It is used for making screw-retained type prosthesis by casting with non-precious metal alloy; and used with Multi Abutment together. It creates framework of the final prosthesis to be fixed on top of the abutment. |
| Material | Co-Cr-Mo Alloy (Cylinder Body) + POM (Cylinder Sleeve) | |
| Diameter (mm) | 5.0 | |
| Length (mm) | 7.3 | |
| Multi Combination Cylinder | Description | Multi Combination Cylinder is used for prosthetic restoration. It is used for making combination-retained type prosthesis with using Multi Abutment together. It |
| tope of the abutment. | ||
| Material | Titanium Gr. 3 (ASTM F67) | |
| Diameter (mm) | 5.0 | |
| Length (mm) | 7.3 | |
| Convertible Angled Cylinder | Description | Convertible Angled Cylinder is used for prostheticrestoration. It is used for making combination-retaiendtype prosthesis by using with Convertible Abutmenttogether. It is used when path adjustment is necessaryat 17° axial angle. |
| Material | Titanium Gr. 3 (ASTM F67) | |
| Diameter (mm) | 4.2, 5.0, 6.3 | |
| Length (mm) | 7.8 | |
| Angulation | 17° | |
| Description | Stud Abutment is used for prosthetic restoration. It isused for making stud type overdenture prosthetics. | |
| Stud Abutment | Material | Titanium Alloy (Ti-6Al-4V, ASTM F136) |
| Diameter (mm) | 3.5 | |
| Head length (mm) | 2.5 | |
| O-ring | Description | O-ring is inserted into retainer or retainer cap andserves as a buffer for abutments/implants and denturefixation. |
| Material | NBR (Acrylonitrile & Butadiene Polymer) | |
| Diameter (mm) | 3.5 | |
| Description | O-ring Retainer Cap is used for making stud-typeoverdenture. It is inserted and fixed into denture; and isconnected with abutment/implants. | |
| O-ring Retainer Cap | Material | Titanium Gr. 3 (ASTM F67) |
| Diameter (mm) | 3.95 | |
| Height (mm) | 2.9 | |
| Description | Port Abutment is used for prosthetic restoration. It isfor implant retained overdenture at maxilla/mandible incase of the patient has no teeth. | |
| Port Abutment | Material | Titanium Alloy (Ti-6Al-4V, ASTM F136) |
| Diameter (mm) | 3.5, 3.7, 4.1, 4.8, 5.1 | |
| G/H (mm) | 1, 2, 3, 4, 5, 6, 7 | |
| Description | Port Angled Abutment is used for prostheticrestoration. It is for implant retained overdentureneeded of path compensation at maxilla/mandible incase of the patient has no teeth. | |
| Port Angled Abutment | Material | Titanium Alloy (Ti-6Al-4V, ASTM F136) |
| Diameter (mm) | 4.63, 4.66, 4.68, 4.72, 4.73, 4.74, 4.77, 4.82 | |
| Height (mm) | 6.5, 6.8, 7.5, 7.6 | |
| Angulation | 10°, 17°, 30° | |
| Port Angled Abutment Head | Description | Port Angled Abutment Head is used for prostheticrestoration. It is a part that is used to connect with PortAngled Abutment. |
| Material | Titanium Alloy (Ti-6Al-4V, ASTM F136) | |
| Diameter (mm) | 4.6 | |
| Height (mm) | 3.7 | |
| Port Male, Port Extended Male | Description | Port Male and Port Extended Male is used forprosthetic restoration. It is used to be inserted betweenPort Abutment/Port Angled Abutment and Port MaleCap and takes a role to maintain retention ofoverdenture. |
| Material | Nylon | |
| Diameter (mm) | 4.75 | |
| Height (mm) | 1.8 | |
| Port Male Cap | Description | Port Male Cap is used for prosthetic restoration. It isused to fix Port Male or Port Extended Male byinserted into the denture. |
| Material | Titanium Alloy (Ti-6Al-4V, ASTM F136) | |
| Diameter (mm) | 5.5 | |
| Height (mm) | 2.25 | |
| Port Male Kit | Description | Port Male Kit is used for prosthetic restoration byproviding accessories that are used with Port Abutmentor Port Angled Abutment, and it is included of PortMale Cap, Port Provisional Male, Port Spacer, and 3different types of Port Male as a set. |
| Set Configuration | Port Male Cap + Port Provisional Male + Port Spacer +Port Male (3ea) | |
| Abutment Screw | Description | Abutment Screw is used to connect an abutment to thefixture. |
| Material | Titanium Alloy (Ti-6Al-4V, ASTM F136) | |
| Diameter (mm) | 2, 2.05 | |
| Length (mm) | 7.5, 9.6 | |
| Cylinder Screw | Description | Cylinder Screw is used to connect a cylinder to theabutment. |
| Material | Titanium Alloy (Ti-6Al-4V, ASTM F136) | |
| Diameter (mm) | 2.2, 2.5 | |
| Length (mm) | 4.35, 4.9 | |
| Esthetic-low Temporary Cylinder | Description | Esthetic-low Temporary Cylinder is used for prostheticrestoration. It is used for making temporary prosthesisbefore loading final prosthesis. It is used by connectedwith Multi Abutment, US Multi Angled Abutment orEsthetic-low Abutment to make overdenture and bridgeas multiple cases. |
| Material | Titanium Gr. 3 (ASTM F67) | |
| Diameter (mm) | 4.8, 5.5 | |
| Length (mm) | 12 | |
| Temporary Cap (Narrow Ridge) | Description | Temporary Cap is used for prosthetic restorationtemporarily. It is a component used to protect upperstructure while final prosthesis is made. |
| Material | PC (Poly Carbonate) | |
| Diameter (mm) | 4 | |
| Length (mm) | 9.6 |
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Image /page/5/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with the superscript "6" next to it. Below the word "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and modern.
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Image /page/6/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with the superscript symbol for a registered trademark next to the "M". Below "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and modern.
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Image /page/7/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a small superscript "6" next to the "M". Below "OSSTEM", the word "IMPLANT" is written in gray. The logo is simple and modern.
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Image /page/8/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a small superscript "6" next to it. Below the word "OSSTEM", the word "IMPLANT" is written in gray. The logo is simple and modern.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
6. Substantial Equivalence Discussion
These subject devices are cleared in past 510(k) submissions but submitted to change their identifiers without modifications of dimensions or shape.
Link Abutment for Cerec, K160519 Multi Angled Abutment, K132067 Abutment Screw, K132067
The Indications for Use Statements are compared in the tables below. It can be seen that the Indications for Use Statements of the Subject and Primary Predicate devices are identical, with the exception of the addition to the Subject Indications for Use Statements language regarding the Link Abutment for CEREC. This language is identical to the Indications for Use Statement of the Reference Device being used for the Substantial Equivalence comparison for the Link Abutment for CEREC. All other reference devices have minor changes in wording, but nothing that affects the intended use or safety and effectiveness of the subject device system.
| Osstem Abutment System | OSSTEM Implant System -Abutment | Link Abutment for CEREC | |
|---|---|---|---|
| 510(k) No. | Proposed | Predicated (K161689) | Referenced (K160519) |
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. |
| Indications forUse Statement | Osstem Abutment System isintended for use with a dentalimplant to provide supportfor prosthetic restorationssuch as crowns, bridges, oroverdentures.• Link Abutment for CERECThe Link Abutment forCEREC is titanium alloyabutments placed ontoOSSTEM dental implants toprovide support forcustomized prostheticrestorations. Link Abutmentfor CEREC is indicated forscrew-retained single tooth orcement-retained single toothand bridge restorations. Alldigitally designed copingsand/or crowns for use withthe Link abutment forCEREC is to be scanned | The OSSTEM ImplantSystem - Abutment isintended for use with a dentalimplant to provide supportfor prosthetic restorationssuch as crowns, bridges, oroverdentures. | The Link Abutment forCEREC is titanium alloyabutments placed ontoHIOSSEN dental implants toprovide support forcustomized prostheticrestorations. Link Abutmentfor CEREC is indicated forscrew-retained single tooth orcement-retained single toothand bridge restorations. Alldigitally designed copingsand/or crowns for use withthe Link abutment forCEREC is to be scannedusing Sirona CEREC AC orCEREC AF or CEREC AI,designed using Sirona inLabsoftware (Version 3.65) orSirona CEREC Software(Version 4.2) andmanufactured using a SironaCEREC or inLab MC X or |
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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 gray. There is a small superscript "6" next to the "M" in "OSSTEM."
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
| using Sirona CEREC AC orCEREC AF or CEREC AI,designed using Sirona inLabsoftware (Version 3.65) orSirona CEREC Software(Version 4.2) andmanufactured using a SironaCEREC or inLab MC X orMC XL milling unit.CAD/CAMmanufacturing/milling occursat dental laboratories per thedesign limitations of theSirona CEREC. | MC XL milling unit.CAD/CAMmanufacturing/milling occursat dental laboratories per thedesign limitations of theSirona CEREC. |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------ |
Except for them, the subject devices are substantially equivalent in indications and design principles to the predicate devices as shown below.
| Transfer Abutment | Transfer Abutment | Remark | |
|---|---|---|---|
| 510(k) No. | Proposed | Predicated (K161689) | - |
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Identical |
| Design | Image: Transfer Abutment | Image: Transfer Abutment | Identical |
| Indications for UseStatement | The Osstem Abutment Systemis intended for use with adental implant to providesupport for prostheticrestorations such as crowns,bridges, or overdentures. | The OSSTEM Implant System- Abutment is intended for usewith a dental implant toprovide support for prostheticrestorations such as crowns,bridges, or overdentures. | Identical |
| Principle ofOperation | Using making for generalcement-type prosthesis. | Using making for generalcement-type prosthesis. | Identical |
| Material | Titanium Alloy(Ti-6Al-4V, ASTM F136) | Titanium Alloy(Ti-6Al-4V, ASTM F136) | Identical |
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. The logo is simple and modern.
| D(Ø) | G/H | Post | D(Ø) | G/H | Post | ||||
|---|---|---|---|---|---|---|---|---|---|
| Dimension (mm) | 4 | 1, 2, 3, 4,5, 6, 7 | 5.5, 7 | -. Addition of Ø4(New, smallestdiameter) | |||||
| 4.6 | 6, 7 | 5.5, 7 | 4.6 | 1, 2, 3, 4,5 | 5.5, 7 | -. Addition of Ø4.6(G/H 6, 7mm) | |||
| 5 | 6, 7 | 4, 5.5,7 | 5 | 1, 2, 3, 4,5 | 4, 5.5,7 | -. Addition of Ø5(G/H 6, 7mm) | |||
| 6 | 6, 7 | 4, 5.5,7 | 6 | 1, 2, 3, 4,5 | 4, 5.5,7 | -. Addition of Ø6(G/H 6, 7mm) | |||
| 7 | 1, 2, 3, 4,5, 6, 7 | 4 | -. Addition of Ø7(Post 4mm) | ||||||
| 7 | 6, 7 | 5.5 | 7 | 1, 2, 3, 4,5 | 5.5 | -. Addition of Ø7(G/H 6, 7mm) | |||
| S.E. | SimilaritiesProposed Transfer Abutment has same design, function and indications for usestatement; and is made with same material with same manufacturing method by samemanufacturer and is generally used for cement-retained restoration compared to that ofthe predicated Transfer Abutment (K161689).DifferencesThe proposed Transfer Abutment has diameter of 4.0 to 7.0mm that has smallestdiameter among the proposed and the predicated Transfer Abutment (K161689).However, the proposed abutment is straight type; therefore, we do not consideradditional fatigue testing... Except for its size of diameter, proposed Transfer Abutment and the predicatedTransfer Abutment have common in design, function, indication for use, material,manufacturing process, manufacturer, etc.; therefore, the proposed Transfer Abutment issubstantially equivalent to the predicated Transfer Abutment (K161689). |
| Angled Abutment | Angled Abutment | Remark | |
|---|---|---|---|
| 510(k) No. | Proposed | Predicated (K120847) | - |
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Identical |
| Design | Image: Angled abutment with TiN Coating | Image: Angled abutment with TiN Coating | Identical except forits TiN coatingsection |
| Indications for UseStatement | The Osstem Abutment Systemis intended for use with a | The abutment is intended foruse with a dental implant | Identical |
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is in orange, with a small superscript "6" next to it. Below "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and clean, with a focus on the company name.
| dental implant to providesupport for prostheticrestorations such as crowns,bridges, or overdentures. | fixture to provide support forprosthetic restorations such ascrowns, bridges, oroverdenture. | ||
|---|---|---|---|
| Principle ofOperation | Using making general cement-type prosthesis when aprosthetic's path adjustment isnecessary. | Using making general cement-type prosthesis when aprosthetic's path adjustment isnecessary. | Identical |
| Material | Titanium Alloy(Ti-6Al-4V, ASTM F136) | Titanium Alloy(Ti-6Al-4V, ASTM F136) | Identical |
| Diameter (mm) | 4.0, 4.5, 5.0, 6.0 | 4.3, 4.5, 5.0, 5.5, 6.0 | Ø4.0 is added; andthe rest is within therange of thepredicates |
| Post Height (mm) | 8 | 8 | Identical |
| Angulation | 17° | 17° | Identical |
| S.E. | SimilaritiesProposed Angled Abutment has same design, function and indications for use statement;and is made with same material with same manufacturing method by same manufacturerand is generally used for cement-retained restoration compared to that of the predicatedAngled Abutment (K120847).DifferencesTiN coating section between the proposed and predicated Angled Abutment is different.The proposed Angled Abutment has diameter of 4.0 to 6.0mm that has smallest diameteramong the proposed and the predicated Angled Abutment (K120847). Therefore, we doconsider the additional fatigue testing.... While TiN coating section is changed and the devices that has different size ofdiameter are added, proposed Angled Abutment and the predicated Angled Abutmenthave common in design, function, indications for use, material, manufacturing process,manufacturer, etc.; therefore, the proposed Angled Abutment is substantially equivalentto the predicated Angled Abutment (K120847). |
| Temporary Abutment | Temporary Abutment | Remark | |
|---|---|---|---|
| 510(k) No. | Proposed | Predicated (K161689) | - |
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Identical |
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a small degree symbol next to the "M". Below the word "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and modern.
| Design | Image: Osstem Abutment System | Image: OSSTEM Implant System - Abutment | Identical except forits shape of the post |
|---|---|---|---|
| Indications for UseStatement | The Osstem Abutment Systemis intended for use with adental implant to providesupport for prostheticrestorations such as crowns,bridges, or overdentures. | The OSSTEM Implant System- Abutment is intended for usewith a dental implant toprovide support for prostheticrestorations such as crowns,bridges, or overdentures. | Identical |
| Principle ofOperation | Cement/screw retainedrestoration; using makingtemporary prosthesis tomaintain aesthetic appearanceuntil final prosthesis is made. | Cement/screw retainedrestoration; using makingtemporary prosthesis tomaintain aesthetic appearanceuntil final prosthesis is made. | Identical |
| Material | Titanium Gr. 3(ASTM F67) | Titanium Gr. 3(ASTM F67) | Identical |
| Diameter (mm) | 4.0, 4.5 | 4.0, 4.5 | Identical |
| Post Height (mm) | 10 | 10 | Identical |
| S.E. | SimilaritiesProposed Temporary Abutment has same design (except for its shape of post), functionand indications for use statement; and is made with same material with samemanufacturing method by same manufacturer and is used for cement/screw-retainedrestoration compared to that of the predicated Temporary Abutment (K161689).DifferencesShape of the post between the proposed and predicated Temporary Abutment isdifferent. Since proposed device is used temporarily, we do not consider additionalfatigue testing... While shape of the post of Temporary Abutment is changed compared to thepredicates, proposed Temporary Abutment and the predicated Temporary Abutmenthave common in design, function, indications for use, material, manufacturing process,manufacturer, etc.; therefore, the proposed Temporary Abutment is substantiallyequivalent to the predicated Temporary Abutment (K161689). |
| Multi NP-CastCylinder | Esthetic-lowGold Cylinder | NP-CastAbutment | Remark | |
|---|---|---|---|---|
| 510(k) No. | Proposed | PrimaryPredicated(K140507) | ReferencePredicated(K140507) | - |
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a small superscript "6" next to the "M". Below "OSSTEM", the word "IMPLANT" is written in gray. The logo is simple and modern.
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Identical | MultiCombination Cylinder | ConvertibleCombination Cylinder | Remark | |
|---|---|---|---|---|---|---|---|---|
| Design | Image: Osstem Abutment System | Image: Hiossen Prosthetic system | Image: Hiossen Prosthetic system | Differentbut similar | 510(k) No. | Proposed | Predicated (K120847) | - |
| Indications forUse Statement | The OsstemAbutment System isintended for use witha dental implant toprovide support forprostheticrestorations such ascrowns, bridges, oroverdentures. | Hiossen Prostheticsystem is intended foruse with a dentalimplant to providesupport for prostheticrestorations such ascrowns, bridges, orover-dentures. | Hiossen Prostheticsystem is intended foruse with a dentalimplant to providesupport for prostheticrestorations such ascrowns, bridges, orover-dentures. | Identical | Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Identical |
| Principle ofOperation | Using making screw-retained typeprosthesis by castingwith non-preciousmetal alloy; and usedwith Multi Abutmenttogether by creatingframework of thefinal prosthesis to befixed on top of theabutment. | Using making screw-retained typeprosthesis by castingwith gold alloy; andused with MultiAbutment orEsthetic-lowAbutment by creatingframework of thefinal prosthesis to befixed on top of theabutment. | Using screw-retainedtype prosthesis incases with path,aesthetic, and spatialconstraints by castingwith non-preciousmetal alloy. | Similar | Design | Similar | ||
| Material | Body: Co-Cr-Mo AlloySleeve: POM | Body: Gold AlloySleeve: POM | Body: Co-Cr-Mo AlloySleeve: POM | Partial Identical | Indications for UseStatement | The Osstem Abutment Systemis intended for use with adental implant to providesupport for prostheticrestorations such as crowns,bridges, or overdentures. | The abutment is intended foruse with a dental implant toprovide support for prostheticrestorations such as crowns,bridges, or overdenture. | Identical |
| Casting Material | Non-preciousmetal alloy | Gold alloy | Non-preciousmetal alloy | Different | Principle ofOperation | Using making combination-retained type prosthesis withusing Multi Abutment togetherby creating framework of thefinal prosthesis to be fixed ontop of the abutment. | Using making combination-retained type prosthesis withusing Convertible Abutmenttogether by creatingframework of the finalprosthesis to be fixed on topof the abutment. | Identical |
| Diameter (mm) | 5.0 | 4.8 | 4.0, 4.5 | Bigger than thepredicates | Material | Titanium Gr. 3(ASTM F67) | Titanium Gr. 3(ASTM F67) | Identical |
| Length (mm) | 7.3 | 10 | 10 | Smaller than thepredicates | Diameter (mm) | 5.0 | 4.2~6.3 | Within the range ofthe predicates |
| S.E. | SimilaritiesProposed Multi NP-Cast Cylinder has similar design that is composed with body andsleeve together; function; indications for use statement; and is used for making screw-retained restoration with Multi Abutment compared to that of the predicated Esthetic-lowGold Cylinder (K140507).DifferencesProposed Multi NP-Cast Cylinder has bigger diameter than that of the predicated Esthetic- | Length (mm) | 7.3 | 7 | Different but similar | |||
| S.E. | SimilaritiesProposed Multi Combination Cylinder has similar design, function, and indications foruse statement; and is made with same material with same manufacturing method bysame manufacturer and is used for making combination-retained restoration with MultiAbutment compared to that of the predicated Convertible Combination Cylinder |
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a small superscript "6" next to the "M". Below "OSSTEM", the word "IMPLANT" is written in gray, in a smaller font size. The logo is simple and clean, with a focus on the company name.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
low Gold Cylinder and NP-Cast Abutment. Also, proposed Multi NP-Cast Cylinder is being casted with non-precious metal alloy as same as the predicated NP-Cast Abutment, but the predicated Esthetic-low Gold Cylinder is being casted with gold alloy. Since the casting material in used for proposed Multi NP-Cast Cylinder has better or substantially equivalent in mechanical strength than that of the predicates; therefore, we do not consider additional fatigue testing.
: · Proposed Multi NP-Cast Cylinder has similar design that is composed with body and sleeve together; function; and indication for use; compared to that of the predicated Esthetic-low Gold Cylinder (K140507). Therefore, the proposed Multi NP-Cast Cylinder and the predicated Esthetic-low Gold Cylinder is substantially equivalent each other.
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with the number "6" as a superscript. Below "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and modern.
| Differences | |
|---|---|
| Dimension between the proposed Multi Combination Cylinder and the predicatedConvertible Combination Cylinder is different. However, proposed Multi CombinationCylinder has diameter that has within the range of the predicates; and it is a straight typecylinder; so, so we do not consider additional fatigue testing. | |
| : · Proposed Multi Combination Cylinder has similar design, function, and indication foruse; and is casting with same material to make final prosthesis compared to that of thepredicated Convertible Combination Cylinder (K120847). Therefore, the proposed MultiCombination Cylinder and the predicated Convertible Combination Cylinder issubstantially equivalent each other. |
| Convertible Angled Cylinder | Convertible Angled Cylinder | Remark | |
|---|---|---|---|
| 510(k) No. | Proposed | Predicated (K063861) | - |
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Identical |
| Design | Image: Convertible Angled Cylinder | Image: Convertible Angled Cylinder with gold coating | Identical except forTiN coating on itssurface |
| Indications for UseStatement | The Osstem Abutment Systemis intended for use with adental implant to providesupport for prostheticrestorations such as crowns,bridges, or overdentures. | GS System is indicated for usein partially or fully edentulousmandibles and maxillae, insupport of single or multiple-unit restorations including;cemented retained, screwretained, or overdentruerestorations, and terminal orintermediate abutment supportfor fixed bridgework. GSSystem is for one stagesurgical procedures. It is notintended for immediate load. | The proposeddevice and thepredicated devicehas differentindication for use inlanguage, howeverthe difference inlanguage does notchange the intendeduse or substantialequivalence status |
| Principle ofOperation | Using making combination-retained type prosthesis byusing with ConvertibleAbutment together when pathadjustment is necessary. | Using making combination-retained type prosthesis byusing with ConvertibleAbutment together when pathadjustment is necessary. | Identical |
| Material | Titanium Gr. 3(ASTM F67) | Titanium Gr. 3(ASTM F67) | Identical |
| Surface | Non-TiN coating | TiN coating | Different |
| Diameter (mm) | 4.2, 5.0, 6.3 | 4.2, 5.0, 6.3 | Identical |
| Length (mm) | 7.8 | 7.8 | Identical |
| Angulation | 17° | 17° | Identical |
{16}------------------------------------------------
Image /page/16/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.
| Connection | Hex, Non-Hex, Octa | Hex, Octa | Identical |
|---|---|---|---|
| S.E. | SimilaritiesProposed Convertible Angled Cylinder has same design (except for its surface on TiN-coated), function and indications for use statement; and is made with same material withsame manufacturing method by same manufacturer and is used for making combination-retained restoration with Convertible Abutment compared to that of the predicatedConvertible Angled Cylinder (K063861).DifferencesProposed Convertible Angled Cylinder has no TiN coating on its surface while thepredicates have TiN coating on its surface. Also, the proposed Convertible AngledCylinder Non-Hex type is added. Since this Non-Hex type addition is made having samedimensions to the predicates; therefore, we do not consider additional fatigue testing.... While proposed devices has non-TiN coated on its surface, proposed ConvertibleAngled Cylinder and the predicated Convertible Angled Cylinder have common indesign, function, indications for use, material, manufacturing process, manufacturer,etc.; therefore, the proposed Convertible Angled Cylinder is substantially equivalent tothe predicated Convertible Angled Cylinder (K063861). |
| Stud Abutment | Stud Abutment | Remark | |
|---|---|---|---|
| 510(k) No. | Proposed | Predicated (K161689) | - |
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Identical |
| Design | Image: Stud Abutment Design | Image: Stud Abutment Design | Identical |
| Indications for UseStatement | The Osstem Abutment Systemis intended for use with adental implant to providesupport for prostheticrestorations such as crowns,bridges, or overdentures. | The OSSTEM Implant System- Abutment is intended for usewith a dental implant toprovide support for prostheticrestorations such as crowns,bridges, or overdentures. | Identical |
| Principle ofOperation | Using making stud typeoverdenture prosthetics | Using making stud typeoverdenture prosthetics | Identical |
| Material | Titanium Alloy(Ti-6Al-4V, ASTM F136) | Titanium Alloy(Ti-6Al-4V, ASTM F136) | Identical |
| Surface | Partial TiN coated in upper | Partial TiN coated in upper | Identical |
{17}------------------------------------------------
Image /page/17/Picture/0 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray below it. There is a small superscript "6" next to the word "OSSTEM".
| D (Ø) | 3.5 | D (Ø) | 3.5 | |||
|---|---|---|---|---|---|---|
| Dimension (mm) | Body Length | 6, 6.4,7,7.4,8, 8.4,9, 9.4,10,10.4,11, 11.4 | Body Length | 6, 6.4,7,7.4,8, 8.4,9, 9.4,10,10.4,11, 11.4 | -. Addition ofabutments havingsmall ball head.: Identical except | |
| HeadDiameter (Ø) | 1.7 | HeadDiameter (Ø) | 2.25 | for head diameter | ||
| HeadLength (H) | 2.5 | HeadLength (H) | 3.35 | and head length | ||
| S.E. | SimilaritiesProposed Stud Abutment has same design, function and indications for use statement;and is made with same material with same manufacturing method by same manufacturerand is used for making overdenture retained restoration compared to that of thepredicated Stud Abutment (K161689).DifferencesProposed Stud Abutment has shorter head length (H, in the image above) and smallerhead diameter compared to that of the predicated Stud Abutment. The shorter headlength of the proposed device allows space when producing overdenture. Except for this,all dimensions are exactly same. However, the proposed abutment is straight type and itdoes not received single load since it is used for overdenture so the load is dispersed;therefore, we do not consider additional fatigue testing..: While proposed devices has shorter head length and smaller head diameter comparedto that of the predicated, proposed Stud Abutment and the predicated Stud Abutmenthave common in design, function, indications for use, material, manufacturing process,manufacturer, etc.; therefore, the proposed Stud Abutment is substantially equivalent tothe predicated Stud Abutment (K161689). |
| O-ring | O-ring | Remark | |
|---|---|---|---|
| 510(k) No. | Proposed | Predicated (K161689) | - |
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Identical |
| Design | Image: O-ring | Image: O-ring | Identical |
| Indications for UseStatement | The Osstem Abutment Systemis intended for use with adental implant to providesupport for prostheticrestorations such as crowns,bridges, or overdentures. | The OSSTEM Implant System- Abutment is intended for usewith a dental implant toprovide support for prostheticrestorations such as crowns,bridges, or overdentures. | Identical |
{18}------------------------------------------------
Image /page/18/Picture/0 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a superscript "6" next to the "M". Below "OSSTEM", the word "IMPLANT" is written in gray. The logo is simple and modern.
| Principle ofOperation | Using inserted into retainer orretainer cap and serves as abuffer for abutments/implantsand denture fixation. | Using inserted into retainer orretainer cap and serves as abuffer for abutments/implantsand denture fixation. | Identical |
|---|---|---|---|
| Material | NBR (Acrylonitrile &Butadiene Polymer) | NBR (Acrylonitrile &Butadiene Polymer) | Identical |
| Diameter (mm) | 3.5 | 4.6 | Different |
| S.E. | SimilaritiesProposed O-ring has same design, function and indications for use statement; and ismade with same material with same manufacturing method by same manufacturercompared to that of the predicated O-ring (K161689).DifferencesProposed O-ring has smaller diameter compared to the predicated O-ring. It is used withStud Abutment that is smaller head length (proposed in this submission) together.: While proposed device has smaller diameter compared to the predicated, proposed O-ring and the predicated O-ring have common in design, function, indications for use,material, manufacturing process, manufacturer, etc.; therefore, the proposed O-ring issubstantially equivalent to the predicated O-ring (K161689). |
| O-ring Retainer Cap | O-ring Retainer Cap | Remark | |
|---|---|---|---|
| 510(k) No. | Proposed | Predicated (K161689) | - |
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Identical |
| Design | Image: O-ring Retainer Cap | Image: O-ring Retainer Cap | Identical |
| Indications for UseStatement | The Osstem Abutment Systemis intended for use with adental implant to providesupport for prostheticrestorations such as crowns,bridges, or overdentures. | The OSSTEM Implant System- Abutment is intended for usewith a dental implant toprovide support for prostheticrestorations such as crowns,bridges, or overdentures. | Identical |
| Principle ofOperation | Using inserted and fixed intodenture; and is connected withabutment/implants. | Using inserted and fixed intodenture; and is connected withabutment/implants. | Identical |
| Material | Titanium Gr. 3 (ASTM F67) | Titanium Gr. 3 (ASTM F67) | Identical |
| Diameter (mm) | 3.95 | 5 | Different |
| Height (mm) | 2.9 | 3.9 | Different |
| S.E. | Similarities |
{19}------------------------------------------------
Image /page/19/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, gray, sans-serif font. To the right of the word "OSSTEM" is a small, raised circle with the number 6 inside.
| Proposed O-ring Retainer Cap has same design, function and indications for usestatement; and is made with same material with same manufacturing method by samemanufacturer compared to that of the predicated O-ring Retainer Cap (K161689). |
|---|
| Differences |
| Proposed O-ring Retainer Cap has smaller diameter and height compared to thepredicated O-ring Retainer Cap. It is used with Stud Abutment that is smaller headlength (proposed in this submission) together. |
| .. While proposed device has smaller diameter and length compared to the predicated,proposed O-ring Retainer Cap and the predicated O-ring Retainer Cap have common indesign, function, indications for use, material, manufacturing process, manufacturer,etc.; therefore, the proposed O-ring Retainer Cap is substantially equivalent to thepredicated O-ring Retainer Cap (K161689). |
| Port Abutment | LOCATOR RTx | Remark | |
|---|---|---|---|
| 510(k) No. | Proposed | Predicated (K150295) | - |
| Manufacturer | Osstem Implant Co., Ltd. | Zest Anchors, Inc. | Different |
| Design | Image: Port Abutment Design | Image: Locator RTX Design | SimilarHead part is whereconnected tooverdenture and thescrew part is whereconnected to theimplanted fixture. |
| Indications for UseStatement | The Osstem Abutment Systemis intended for use with adental implant to providesupport for prostheticrestorations such as crowns,bridges, or overdentures. | The LOCATOR® RTx ImplantAttachment System isdesigned for use withoverdentures or partialdentures, retained in whole orin part, by endosseousimplants in the mandible ormaxilla. | The proposeddevice and thepredicated devicehas differentindication for use inlanguage, howeverthe difference inlanguage does notchange the intendeduse or substantialequivalence status. |
| Principle ofOperation | Using making implant retainedoverdenture atmaxilla/mandible. | Using making implant retainedoverdenture atmaxilla/mandible. | Identical |
| Material | Titanium Alloy(Ti-6Al-4V, ASTM F136) | Titanium Alloy(Ti-6Al-4V ELI) | Identical |
| Surface | Partial TiN coated in upper | TiCN or TiN coating | Within the range ofthe predicates |
| Diameter (mm) | 3.5 ~ 5.1 | 3.0 ~ 7.0 | Within the range ofthe predicates |
{20}------------------------------------------------
Image /page/20/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.
| G/H (mm) | 1 ~ 7 | 1 ~ 6 | Exceed (bigger than) the range of the predicates |
|---|---|---|---|
| Abutment Angle | Straight | Straight | Identical |
| S.E. | SimilaritiesProposed Port Abutment design, function, indications for use statement, is made with same material and is used for making overdenture retained restoration compared to that of the predicated LOCATOR RTx (K150295).DifferencesDimension between the proposed and the predicates are different: proposed Port Abutment has diameter range from 3.5 to 5.1 whilte the predicated LOCATOR RTx has range from 3.0 to 7.0. Also, proposed Port Abutment has G/H range from 1 to 7 while the predicated LOCATOR RTx has range from 1 to 6.Proposed Port Abutment has TiN coating on its surface while the predicated LOCATOR RTx has either TiCN or TiN coating on its surface. Proposed abutment is straight type, is intended for straight implantation, and is not received single load because this is used for making overdenture that means load is dispersed to the full denture; therefore, we do not consider additional fatigue testing.∴ Proposed Port Abutment has similar design, function, and indication for use; and is made with same material compared to that of the predicated LOCATOR RTx (K150295). Since diameter and G/H of the proposed device are within or larger than the predicated device dimension, no additional safety and effectivencess evaluation is required. Therefore, the proposed Port Abutment and the predicated LOCATOR RTx is substantially equivalent each other. |
| Port Angled Abutment &Port Angled AbutmentHead | Multi AngledAbutment | LOCATOR RTx | Remark | Design | Different | Port MalePort Extended Male | Retention Insert | Remark | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 510(k) No. | Proposed | PrimaryPredicated(K132067) | ReferencePredicated(K150295) | - | Indications forUse Statement | The Osstem AbutmentSystem is intended for usewith a dental implant toprovide support forprosthetic restorations suchas crowns, bridges, oroverdentures. | Multi AngledAbutment isintended for usewith a dentalimplant to providesupport forprostheticrestorations suchas bridges, oroverdentures. | The LOCATOR®RTx ImplantAttachment Systemis designed for usewith overdenturesor partial dentures,retained in whole orin part, byendosseousimplants in themandible ormaxilla. | The proposeddevice and thepredicateddevice hasdifferentindication foruse inlanguage,however thedifference inlanguage doesnot change theintended use orsubstantialequivalencestatus. | 510(k) No. | Proposed | Predicated (K150295) | - |
| Manufacturer | Osstem Implant Co. Ltd. | Zest Anchors,LLC | Different | Principle ofOperation | Using making implantretained overdenture neededof path compensation atmaxilla/mandible. | Using makingscrew-retainedtype prosthesis inmultiple cases byusing withEsthetic-lowcylinder whenpath adjustment isnecessary. | Using for implantretainedoverdenture atmaxilla/mandible. | Similar | Manufacturer | Osstem Implant Co., Ltd. | Zest Anchors, Inc. | Different | |
| Material | Titanium Alloy(Ti-6Al-4V,ASTM F136) | Titanium Alloy(Ti-6Al-4V,ASTM F136) | Titanium Alloy(Ti-6Al-4V ELI) | Identical | Design | Image: Port Male Port Extended Male Design | Image: Retention Insert Design | Similar | |||||
| Diameter (mm) | 4.63 ~ 4.82 | 4.9 | 3.0 ~ 7.0 | Within therange of thepredicates | Indications for UseStatement | The Osstem Abutment Systemis intended for use with adental implant to providesupport for prostheticrestorations such as crowns,bridges, or overdentures. | The LOCATOR® RTx ImplantAttachment System isdesigned for use withoverdentures or partialdentures, retained in whole orin part, by endosseousimplants in the mandible ormaxilla. | The proposeddevice and thepredicated devicehas differentindication for use inlanguage, howeverthe difference inlanguage does notchange the intendeduse or substantialequivalence status. | |||||
| Abutment Angle | 10°/17°/30° | 17°/30° | Straight | Different | Principle ofOperation | Using inserted between PortAbutment/Port AngledAbutment and Port Male Capand takes a role to maintainretention of overdenture. | Using inserted betweenLocator RTx and dentalattachment housing and takes arole to maintain retention ofoverdenture. | Identical | |||||
| S.E. | SimilaritiesProposed Port Angled Abutment has similar indications for use statement, design, function,abutment angle, is made with same raw material, and is used for making overdenture | Material | Nylon | Nylon or PEEK | Within the range ofthe predicates |
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Image /page/21/Picture/0 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is written in large, bold, orange letters. Below it, the word "IMPLANT" is written in smaller, gray letters. A small superscript "6" is located to the right of the word "OSSTEM".
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Image /page/22/Picture/0 description: The image shows the logo for Osstem Implant. The logo is 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 51 861 4693 www.osstem.com
retained restoration compared to that of the primary predicate device, Multi Angled Abutment (K132067). Proposed Port Angled Abutment has diameter which is within the range of the reference predicate device, LOCATOR RTx (K150295).
Differences
While proposed Port Angled Abutment has angle of 10, 17, and 30 degrees, the primary predicate device, Multi Angled Abutment has angle of 17 and 30 degrees; but the reference device, LOCATOR RTx is straight type abutment. Proposed Port Angled Abutment should be used connected by Port Angled Abutment Head together to place overdenture on top of the abutment but reference predicate. Since proposed Port Angled Abutment is used to make overdenture and does not receive single load because the load is dispersed to the denture; therefore, we do not consider additional fatigue testing.
·· Proposed Port Angled Abutment has similar indication for use, design, function, abutment angle, and is made with same raw material compared to that of the primary predicate device. Multi Angled Abutment (K132067): and it has diameter that is within the range of the reference predicate device, LOCATOR RTx (K150295). Therefore, the proposed Port Angled Abutment is substantially equivalent to the predicates.
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Image /page/23/Picture/0 description: The image contains the logo for "OSSTEM IMPLANT". The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. The word "IMPLANT" is located directly below the word "OSSTEM".
| Similarities | |
|---|---|
| Proposed Port Male/Port Extended Male has similar design, function, indications for usestatement, and is made with one of same materials compared to that of the predicatedRetention Insert (K150295). | |
| Differences | |
| S.E. | Proposed Male has 6 different types based on its retention levels while the predicatedRetention Insert has simplified 4 different types based on its retention levels from zeroto high. |
| · Proposed Port Male/Port Extended Male has similar design, function, and indicationfor use; and is made with one of same materials compared to that of the predicatedRetention Insert (K150295). Therefore, the proposed Port Male/Port Extended Male andthe predicated Retention Insert is substantially equivalent each other. |
| Port Male Cap | Denture AttachmentHousing | Remark | |
|---|---|---|---|
| 510(k) No. | Proposed | Predicated (K150295) | - |
| Manufacturer | Osstem Implant Co., Ltd. | Zest Anchors, Inc. | Different |
| Design | Image: Port Male Cap | Image: Denture Attachment Housing | Similar |
| Indications for UseStatement | The Osstem Abutment Systemis intended for use with adental implant to providesupport for prostheticrestorations such as crowns,bridges, or overdentures. | The LOCATOR® RTx ImplantAttachment System isdesigned for use withoverdentures or partialdentures, retained in whole orin part, by endosseousimplants in the mandible ormaxilla. | The proposeddevice and thepredicated devicehas differentindication for use inlanguage, howeverthe difference inlanguage does notchange the intendeduse or substantialequivalence status. |
| Principle ofOperation | Using fixing Port Male or PortExtended Male by inserted intothe denture. | Using fixing Retention Insertby inserted into the denture. | Identical |
| Material | Titanium Alloy(Ti-6Al-4V, ASTM F136) | Titanium Alloy(Ti-6Al-4 ELI) | Identical |
| S.E. | SimilaritiesProposed Port Male Cap has similar design, function, indications for use statement, andis made of same material compared to that of the predicated Denture AttachmentHousing (K150295). |
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Image /page/24/Picture/0 description: The image shows the logo for OSSTEM IMPLANT. The word "OSSTEM" is in orange, with a small orange circle above the "M". Below "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and modern.
| DifferencesProposed Port Male Cap is not applied of surface treatment while the predicated DentureAttachment Housing has applied of pink anodizing on its surface. | |
|---|---|
| :: Proposed Port Male Cap has similar design, function, and indication for use; and ismade with same material compared to that of the predicated Denture AttachmentHousing (K150295). Therefore, the proposed Port Male Cap and the predicated DentalAttachment Housing is substantially equivalent each other. |
| EbonyGold Cylinder Screw | EbonyGold Cylinder Screw | Remark | |
|---|---|---|---|
| 510(k) No. | Proposed | Predicated (K120847) | - |
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Identical |
| Design | Image: EbonyGold Cylinder Screw | Image: EbonyGold Cylinder Screw | Identical |
| Indications for UseStatement | The Osstem Abutment Systemis intended for use with adental implant to providesupport for prostheticrestorations such as crowns,bridges, or overdentures. | The abutment is intended foruse with a dental implantfixture to provide support forprosthetic restorations such ascrowns, bridges, oroverdenture. | Identical |
| Principle ofOperation | Using to connect a cylinder tothe abutment. | Using to connect a cylinder tothe abutment. | Identical |
| Material | Titanium Alloy(Ti-6Al-4V, ASTM F136) | Titanium Alloy(Ti-6Al-4V, ASTM F136) | Identical |
| Diameter (mm) | 2.2, 2.5 | 2.2, 2.5 | Identical |
| Length (mm) | 4.35, 4.9 | 4.15, 4.7 | Different |
| S.E. | SimilaritiesProposed Abutment Screw has same design, function and indications for use statement;and is made with same material with same manufacturing method by same manufacturercompared to that of the predicated Abutment Screw (K120847).DifferencesProposed Abutment Screw has same diameter, but longer in length compared to thepredicated Abutment Screw.. While proposed device has longer in length compared to the predicated, proposedAbutment Screw and the predicated Abutment Screw have common in design, function,indications for use, material, manufacturing process, manufacturer, etc.; and thedifference does not affect to safety and effectiveness of the product. Therefore, theproposed Abutment Screw is substantially equivalent to the predicated Abutment Screw(K120847) |
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Image /page/25/Picture/0 description: The image contains the word "OSSTEM" in orange, with the word "IMPLANT" in gray underneath. The number 6 is in superscript next to the word "OSSTEM". The logo is simple and modern.
| Esthetic-lowTemporaryCylinder | Esthetic-lowTemporaryCylinder | Esthetic-lowTemporaryCylinder | Remark | |
|---|---|---|---|---|
| 510(k) No. | Proposed | Predicated(K062030) | Predicated(K160670) | - |
| Manufacturer | Osstem ImplantCo., Ltd. | Osstem ImplantCo., Ltd. | Osstem ImplantCo., Ltd. | Identical |
| Design | Image: cylinder | Image: cylinder | Image: cylinder | Shape of post isdifferent |
| Indications for UseStatement | The OsstemAbutment System isintended for use witha dental implant toprovide support forprostheticrestorations such ascrowns, bridges, oroverdentures. | US system and SSIImini are indicatedfor use in partially orfully edentulousmandibles andmaxillae, in supportof single or multiple-unit restorationsincluding; cementedretained, screwretained, oroverdenturerestorations, andterminal orintermediateabutment support forfixed bridgework.US System is fortwo stage surgicalprocedures. It is notfor one stage surgeryor immediate load.The SSII mini is forone and two stagesurgical procedures.It is not forimmediate load. | The OSSTEMProsthetic System isintended for use witha dental implant toprovide support forprosthetic restorationsuc h as crowns,bridges, or over-dentures. | The proposeddevice and thepredicated devicehas differentindication for usein language,however thedifference inlanguage doesnot change theintended use orsubstantialequivalencestatus |
| Principle ofOperation | Screw retainedrestoration; usingmaking temporaryprosthesis beforeloading finalprosthesis byconnected withMulti Abutment, USMulti Angled | Screw retainedrestoration; usingmaking temporaryprosthesis beforeloading finalprosthesis byconnected withMulti Abutment, USMulti Angled | Screw retainedrestoration; usingmaking temporaryprosthesis beforeloading finalprosthesis byconnected withMulti Abutment, USMulti Angled | Identical |
| Abutment orEsthetic-lowAbutment to makeoverdenture andbridge as multiplecases. | Abutment orEsthetic-lowAbutment to makeoverdenture andbridge as multiplecases. | Abutment orEsthetic-lowAbutment to makeoverdenture andbridge as multiplecases. | ||
| Material | Titanium Gr. 3(ASTM F67) | Titanium Gr. 3(ASTM F67) | Titanium Gr. 3(ASTM F67) | Identical |
| Diameter (mm) | 4.8, 5.5 | 5.3, 6.0 | 4.8, 5.5 | Partial identical |
| Post Diameter (mm) | 3.7, 4.1 | 3.8, 4.2 | 3.35, 3.8 | Different |
| Length (mm) | 12 | 12 | 12 | Identical |
| Type | Standard Type | Standard Type | Narrow Type | Partial identical |
| Connection | External Hex | External Hex | External Hex | Identical |
| S.E. | SimilaritiesProposed Esthetic-low Temporary Cylinder has same connection structure, function,indications for use statement; and is made with same material with same manufacturingmethod by same manufacturer and is used for making screw-retained restorationcompared to that of the predicated Esthetic-low Temporary Cylinder (K062030,K160670).DifferencesProposed Esthetic-low Temporary Cylinder is standard type, has smaller diameter, samelength, but different shape of post compared to that of the predicated Esthetic-lowTemporary Cylinder (K062030). However, it has same shape of post, diameter, length,indication, etc., but bigger post diameter compared to that of the predicated narrow typeEsthetic-low Cylinder (K160670). Since proposed device is used temporarily and doesnot have smallest diameter in this submission, we do not consider additional fatiguetesting.• While proposed device has smaller diameter, same length, but different shape of postcompared to the predicated, proposed Esthetic-low Temporary Cylinder and thepredicated Esthetic-low Temporary Cylinder have common in function, indications foruse, material, manufacturing process, manufacturer, etc.; and the difference does notraise safety and effectiveness issue. Therefore, the proposed Esthetic-low TemporaryCylinder is substantially equivalent to the predicated Esthetic-low Temporary Cylinder(K062030, K160670). |
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Image /page/26/Picture/0 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is in orange, with a superscript "6" next to the "M". Below "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and clean, with a focus on the company name.
| Temporary Cap | Temporary Cap | Remark | |
|---|---|---|---|
| 510(k) No. | Proposed | Predicated (K080594) | - |
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Identical |
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Image /page/27/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 below it. The logo is simple and modern, and it is likely used to promote the company's dental implant products.
| Design | Shape of post isdifferent | ||
|---|---|---|---|
| Indications for UseStatement | The Osstem Abutment Systemis intended for use with adental implant to providesupport for prostheticrestorations such as crowns,bridges, or overdentures. | The MS System (NarrowRidge) is intended to use in thetreatment of missingmandibular central and lateralincisors to support prostheticdevice, such as artificial teeth,in order to restore chewingfunction in partiallyedentulous patients. MSSystem (Narrow Ridge) areintended for single use only. | The proposeddevice and thepredicated devicehas differentindication for use inlanguage, howeverthe difference inlanguage does notchange the intendeduse or substantialequivalence status |
| Principle ofOperation | Using making prostheticrestoration temporarily byprotecting upper structurewhile final prosthesis is made. | Using making prostheticrestoration temporarily byprotecting upper structurewhile final prosthesis is made. | Identical |
| Material | PC (Poly Carbonate) | PC (Poly Carbonate) | Identical |
| Diameter (mm) | 4 | 3.95(4) | Identical(within its toleranceof ± 0.05) |
| Length (mm) | 9.6 | 9.6 | Identical |
| S.E. | SimilaritiesProposed Temporary Cap has same basic structure, function, indications for usestatement; and is made with same material with same manufacturing method by samemanufacturer compared to that of the predicated Temporary Cap (K080594).DifferencesProposed Temporary Cap has different shape of post compared to the predicatedTemporary Cap.. · While proposed device has different shape of post compared to the predicated,proposed Temporary Cap and the predicated Temporary Cap have common in function,indications for use, material, manufacturing process, manufacturer, etc .; and thedifference does not raise safety and effectiveness issue. Therefore, the proposedTemporary Cap is substantially equivalent to the predicated Temporary Cap (K080594). |
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Image /page/28/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" also appearing in orange next to the company name. Below the company name is the address: 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea, as well as the telephone number: +82 51 850 2500, fax number: +82 51 861 4693, and website: www.osstem.com.
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- Summary of Non-clinical Performance Testing
Non-clinical testing data are submitted, referenced, or relied upon to demonstrate substantial equivalence.
- Summary of Non-clinical Performance Testing
Biocompatibility Evaluation
Biocompatibility testing was performed following 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"and the ISO 10993 suite of standards.
Sterilization Validation
Subject devices are provided to the market in non-sterile status, and steam sterilization validation was considered according to ISO 17665-1.
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. Retention testing for dental attachments was conducted.
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- Summary of Clinical Testing
No clinical studies are submitted.
- Summary of Clinical Testing
9. Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, OSSTEM IMPLANT Co., Ltd. concludes that Osstem Abutment System is substantially equivalent to the predicates devices as 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.)