(417 days)
Not Found
No
The device description and performance studies focus on mechanical properties and structural integrity, with no mention of AI/ML terms or functionalities.
No
The device is described as an aid in prosthetic restoration for dental implants, providing support for crowns, bridges, or over-dentures, rather than directly treating a disease or condition.
No
The device is described as providing support for prosthetic restorations and aid in prosthetic restoration, rather than identifying or diagnosing a condition.
No
The device description clearly states it is a physical device made of titanium alloy, consisting of abutments and screws, intended for use with dental implants. It describes physical characteristics and materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide support for prosthetic restorations such as crowns, bridges, or over-dentures" in conjunction with a dental implant. This is a mechanical function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical device made of titanium alloy with specific connection structures. It does not describe reagents, test kits, or any components used for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly a dental prosthetic component intended for surgical implantation and support of dental restorations.
N/A
Intended Use / Indications 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.
Product codes
NHA
Device 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.
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 clinical testing
No clinical studies were submitted to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
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Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health & Human Services.
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
1
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
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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
4
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 | |
|---|---|---|
| Transfer | ||
| Abutment | Description | Use for marking general cement-type prosthesis |
| Material | Titanium Alloy (Ti-6Al-4V) / TiN-coating (middle coating) | |
| Diameter | Ø 4.0mm | |
| Gingival | ||
| heights | 1.0mm, 2.0mm, 3.0mm, 4.0mm, 5.0mm | |
| type of | ||
| connection | 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 | |
| Gingival | ||
| heights | 2.0mm, 4.0mm | |
| type of | ||
| connection | 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 for
dimensional changes. There are no changes in function and intended use between
the subject device and the predicate devices. No biocompatibility testing,
sterilization validation or packaging validation needed to be performed because
the material, coating, manufacturing process and packaging are identical between
the predicate and subject device (K130662). | |
| Reason for
change | 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 for
dimensional changes. There are no changes in function and intended use between
the subject device and the predicate devices. No biocompatibility testing,
sterilization validation or packaging validation needed to be performed because
the material, coating, manufacturing process and packaging are identical between
the predicate and subject device (K120847). | |
| Reason for
change | 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