(417 days)
Transfer & Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.
The Transfer & Angled Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. It consists of Abutments and Abutment Screws. Surfaces are partially TiN coated.
The Transfer & Angled Abutment has mini connection structure that is consist two types of connection structure (Non-HEX and HEX (including A type hex)
Non-HEX connection of Transfer & Angled Abutment has a 11° Morse taper structure Hex Mini connection of Transfer & Angled Abutment has a 11° Morse taper structure and 2.08mm Hex connection structure.
Angled Abutment two types of Hex connection (A type hex, B type hex) to set direction (Double hex function)
Hex connection structure has function for anti-rotation
The provided document is a 510(k) premarket notification for a medical device called "Transfer & Angled Abutment." This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study proving that the device meets specific acceptance criteria based on its performance characteristics.
Therefore, many of the requested categories for the description of "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in this context.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
This document does not establish specific performance acceptance criteria for the "Transfer & Angled Abutment" as it would for a novel device requiring efficacy or safety trials. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to existing predicate devices (K130662 and K120847). The "reported device performance" is not explicitly quantified in terms of clinical outcomes, but rather inferred from the fact that its material, function, and intended use are highly similar to the predicate devices, and that it passed non-clinical fatigue testing.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate Devices) | Reported Device Performance (as per 510(k) Summary) |
|---|---|
| Material Composition (Same as predicate) | Transfer Abutment: Titanium Alloy (Ti-6Al-4V) / TiN-coating. Angled Abutment: Titanium Alloy (Ti-6Al-4V) / TiN-coating. (Matches predicate material) |
| Design / Form (Similar to predicate, with dimensional changes stated) | Transfer Abutment: 11° Morse taper internal connection, Mini Connection. Diameter Ø 4.0mm. Gingival heights: 1.0mm, 2.0mm, 3.0mm, 4.0mm, 5.0mm. Post Height: 5.5mm, 7.0mm. Angled Abutment: 11° Morse taper internal connection, Mini Connection. Diameter Ø 4.0mm. Angled: 17°. Gingival heights: 2.0mm, 4.0mm. The primary change for both is the addition of a 4.0mm diameter, while predicate devices had other specified diameters (e.g., K130662 had 4.6, 5.0, 6.0, 7.0mm; K120847 had 4.3, 4.5, 5.0, 5.5, 6.0mm). The document states, "The subject device and the predicate device... are the same except for dimensional changes. There are no changes in function and intended use..." |
| Intended Use (Same as predicate) | Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures. (Matches predicate's intended use). |
| Biocompatibility (Implied by material equivalence) | Not explicitly tested, "No biocompatibility testing... needed to be performed because the material, coating, manufacturing process and packaging are identical between the predicate and subject device." |
| Sterilization Validation (Implied by process equivalence) | Not explicitly tested, "No... sterilization validation... needed to be performed because the material, coating, manufacturing process and packaging are identical between the predicate and subject device." |
| Packaging Validation (Implied by process equivalence) | Not explicitly tested, "No... packaging validation needed to be performed because the material, coating, manufacturing process and packaging are identical between the predicate and subject device." |
| Mechanical Performance (Fatigue) | 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. (The document states it was "considered" and passed, although specific results are not provided here). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. This submission relies on substantial equivalence to predicate devices and non-clinical fatigue testing, not a clinical test set with human or patient data.
- Data Provenance: The fatigue testing would be laboratory-based (non-clinical). The origin of the device manufacturer is Republic of Korea.
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 ground truth establishment by experts for a test set is described in this 510(k) summary, as it is not a clinical study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a dental implant abutment, not an AI-powered diagnostic device. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Non-clinical testing: The "ground truth" for the fatigue testing would be the established engineering standards and guidelines for dental implant abutments (e.g., ISO 14801 or similar, as referenced by the "Guidance for industry and FDA staff Class II Special Controls Guidance Document").
- Substantial Equivalence: The "ground truth" for demonstrating substantial equivalence is the existing performance and safety profile of the predicate devices.
8. The sample size for the training set
- Not applicable. This is not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. This is not a machine learning model.
In summary:
This 510(k) submission successfully argues for substantial equivalence primarily based on:
- Identical materials, coating, manufacturing processes, and packaging to the predicate devices.
- Identical intended use to the predicate devices.
- Dimensional changes (addition of a 4.0mm diameter) which were not deemed to alter the fundamental function or safety.
- Non-clinical fatigue testing performed according to relevant guidance, confirming the mechanical integrity of the device, particularly focusing on a "worst-case scenario."
The FDA's review and clearance indicate that the provided evidence was sufficient to demonstrate that the new device is as safe and effective as the predicate devices, without requiring a detailed clinical performance study with human subjects.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5, 2016
OSSTEM Implant Co., Ltd % David Kim RA/OA Manager HIOSSEN Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030
Re: K153015
Trade/Device Name: Transfer & Angled Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 3, 2016 Received: November 3, 2016
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 yours,
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/1 description: The image shows the logo and address of OSSTEM Implant Co., Ltd. The logo includes the company name in bold, black font, with the word "OSSTEM" slightly offset and larger than the rest of the name. Below the company name is the address: 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea. To the left of the company name is a smaller, stylized version of the word "OSSTEM" in orange.
Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
Indications for Use Statement
510(k) Number K 153015
3
Device Name : Transfer & Angled Abutment
Indication for use :
Transfer & Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.
Prescription Use (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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STEM Implant Co., Ltd.
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 : November 23, 2016
| - 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 : | Transfer & Angled Abutment |
| Common or usual name : | Dental Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Regulation Name: | Endosseous Dental Implant Abutment |
| Regulatory Class: | Class II |
| Product Code: | NHA |
3. Predicate Device:
Primary predicate
ET Prosthetic System, OSSTEM CO., LTD., K130662 ET SS Implant System, OSSTEM CO., LTD., K120847
-
- Description :
The Transfer & Angled Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. It consists of Abutments and Abutment Screws. Surfaces are partially TiN coated.
- Description :
The Transfer & Angled Abutment has mini connection structure that is consist two types of connection structure (Non-HEX and HEX (including A type hex)
Non-HEX connection of Transfer & Angled Abutment has a 11° Morse taper structure Hex Mini connection of Transfer & Angled Abutment has a 11° Morse taper structure and 2.08mm Hex connection structure.
Angled Abutment two types of Hex connection (A type hex, B type hex) to set direction (Double hex function)
Hex connection structure has function for anti-rotation
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Image /page/4/Picture/0 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a stylized font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, gray font. The logo is simple and modern.
OSSTEM Implant Co., Ltd.
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
| Item | Content | |
|---|---|---|
| TransferAbutment | Description | Use for marking general cement-type prosthesis |
| Material | Titanium Alloy (Ti-6Al-4V) / TiN-coating (middle coating) | |
| Diameter | Ø 4.0mm | |
| Gingivalheights | 1.0mm, 2.0mm, 3.0mm, 4.0mm, 5.0mm | |
| type ofconnection | 11° Morse taper internal connection | |
| connection | Mini Connection | |
| Post Height | 5.5mm, 7.0mm | |
| Angled Abutment | Description | Use for marking general cement-type prosthesis |
| Material | Titanium Alloy (Ti-6Al-4V) / TiN-coating | |
| Diameter | Ø 4.0mm | |
| Gingivalheights | 2.0mm, 4.0mm | |
| type ofconnection | 11° Morse taper internal connection | |
| connection | Mini Connection | |
| Angle | 17° |
- Substantial Equivalence Matrix
| Part Name | Transfer Abutment | Primary predicate:Transfer Abutment |
|---|---|---|
| Proposed | Predicate | |
| 510K | - | K130662 |
| Material | Titanium Alloy | Titanium Alloy |
| Design | Image: Transfer Abutment Proposed | Image: Transfer Abutment Predicate |
| Dimension(Diameter) | 4.0mm | 4.6, 5.0, 6.0, 7.0mm |
| Coating | TiN coating | TiN coating |
| SE | The subject device and the predicate device (K130662) are the same except fordimensional changes. There are no changes in function and intended use betweenthe subject device and the predicate devices. No biocompatibility testing,sterilization validation or packaging validation needed to be performed becausethe material, coating, manufacturing process and packaging are identical betweenthe predicate and subject device (K130662). | |
| Reason forchange | Addition Art# of diameter 4.0mm |
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Image /page/5/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. There is a small orange superscript "6" in the upper right corner of the logo.
OSSTEM Implant Co., Ltd.
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
| Part Name | Angled Abutment | Primary predicate:Angled Abutment |
|---|---|---|
| Proposed | Predicate | |
| 510K | - | K120847 |
| Material | Titanium Alloy | Titanium Alloy |
| Design | Image: Angled Abutment Proposed | Image: Angled Abutment Predicate |
| Dimension(Diameter) | 4.0mm | 4.3, 4.5, 5.0, 5.5, 6.0mm |
| Angled | 17° | 17° |
| Coating | TiN coating | TiN coating |
| SE | The subject device and the predicate device (K120847) are the same except fordimensional changes. There are no changes in function and intended use betweenthe subject device and the predicate devices. No biocompatibility testing,sterilization validation or packaging validation needed to be performed becausethe material, coating, manufacturing process and packaging are identical betweenthe predicate and subject device (K120847). | |
| Reason forchange | Addition Art# of diameter 4.0mm |
5. Indication for use:
Transfer & Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.
-
- Summary of nonclinical testing
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 nonclinical testing
7. Summary of clinical testing
No clinical studies were submitted to support substantial equivalence.
-
- Conclusions
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 CO., LTD. concludes that Transfer & Angled Abutment is substantially equivalent to the predicate devices as described herein
- Conclusions
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Image /page/6/Picture/1 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. There is a small orange circle with the number 6 in the upper right corner of the logo.
OSSTEM Implant Co., Ltd.
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
§ 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.)