(170 days)
K62030, K101096
No
The device description and intended use focus solely on the mechanical components and function of a dental abutment system. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No.
The device is a dental abutment intended for prosthetic restoration, which supports a prosthetic device rather than directly treating a disease or condition. While it aids in restoration, its primary function is structural support for prosthetics, not therapeutic.
No
The device is an abutment system intended to provide support for prosthetic restorations with dental implants. It does not perform any diagnostic function.
No
The device description clearly states it is made of titanium alloy and is a physical component (abutment) used in dental restorations. It is a hardware device.
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 dental restorations. This is a mechanical function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a titanium alloy abutment used with dental implants. This is a medical device used for structural support, not for analyzing biological samples.
- Lack of IVD Characteristics: The description 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
In summary, the Multi Angled Abutment system is a dental prosthetic component, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Multi Angled Abutment system is intended for use with a dental implant to provide support for prosthetic restorations such as bridges, or overdentures.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Multi Angled Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration.
The Multi Angled Abutment is used with Esthetic -low Cylinders (only Non-Hex) in the US System, K62030 and connected to HTIII SA Fixture in the HTIII SA Fixture System, K101096
The Multi Angled Abutment system consists of Abutment combined carrier that is tool to carry Multi angled abutment. and Abutment Screw.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical studies are submitted
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
0
KNB2067
DEC 2 0 2013
Image /page/0/Picture/2 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The address is #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea. The telephone number is +82 51 850-2500, the fax number is +82 51 850-4341, and the website is www.osstem.com.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
OSSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu
Mr. Hee Kwon Son
+82 51 850 2575
HIOSSEN Inc.
Patrick Lim 888 678 0001
Busan, 611-804, Republic of Korea
85 Ben Fairless Dr. Fairless Hills, PA 19030
Date: June 27, 2013
- Company and Correspondent making the submission:
-
Submitter`s Name :
-
Address :
-
Contact :
-
Phone:
-
Correspondent`s Name:
-
Address:
-
Contact:
-
Phone:
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- Device :
Trade or (Proprietary) Name : Common or usual name : Classification Name :
Multi Angled Abutment system Dental Abutment Abutment, implant, dental, endosseous 21CFR872.3630 Class II NHA
-
- Predicate Device :
Multi Angled Abutment, OSSTEM Implant Co., Ltd., K123755
- Predicate Device :
-
- Description :
The Multi Angled Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration.
- Description :
The Multi Angled Abutment is used with Esthetic -low Cylinders (only Non-Hex) in the US System, K62030 and connected to HTIII SA Fixture in the HTIII SA Fixture System, K101096
- I) The Multi Angled Abutment system consists of Abutment combined carrier that is tool to carry Multi angled abutment. and Abutment Screw.
QS-Q1-505-3(Rev.0)
1
Image /page/1/Picture/0 description: The image shows the text "OSSTEM Implant Co., Ltd." The text is in bold, black font and is centered on a white background. The text appears to be the name of a company.
#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
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- The Multi Angled Abutment system is exactly same with Multi Angled Abutment (K123755) except combined carrier
| Multi Angled Abutment system | Multi Angled Abutment | |
|---|---|---|
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd |
| 510(k) Number | New | K123755 |
| Design | Image: Multi Angled Abutment system design | Image: Multi Angled Abutment design |
| Intended use | Multi Angled Abutment is intended for | |
| use with a dental implant to provide | ||
| support for prosthetic restorations such | ||
| as bridges, or overdentures. | Multi Angled Abutment is intended for | |
| use with a dental implant to provide | ||
| support for prosthetic restorations such | ||
| as bridges, or overdentures. | ||
| Abutment | ||
| Angle(°) | 17, 30 | 17, 30 |
| platform(Ø) | 4.8 | 4.8 |
| Connection | The Multi Angled Abutment system is exactly same with Multi Angled | |
| Abutment(K123755) except combined carrier. | ||
| Carrier is just to carry the Multi Angled Abutment to implanted Fixture |
- Substantial Equivalence Matrix
- Indication for use :
The Multi Angled Abutment system is intended for use with a dental implant to provide support for prosthetic restorations such as bridges, or overdentures.
ਾਂ
2
Image /page/2/Picture/0 description: The image shows the logo for OSSTEM Implant. The logo is in black and white and features the word "OSSTEM" in a stylized font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern, and it is likely used to represent a company that manufactures or sells dental implants.
OSSTEM Implant Co., Ltd.
#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
6. Review :
The Multi Angled Abutment system is merely improved for movement convenience of abutment by combination of carrier therefore, The Multi Angled Abutment is nothing changed from predicated Multi Angled Abutment (K123755) except combined carrier
7. Summary of nonclinical testing
The risks associated with the modification were evaluated via a DCAS table and it was determined that no performance testing is needed. However, minor modifications were made to the labeling.
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- Summary of clinical testing No clinical studies are submitted
9. 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 Implant Co., Ltd. concludes that the Multi Angled Abutment system is substantially equivalent to the predicate devices as described herein.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 20, 2013
OSSTEM Implant Company, Limited C/O Mr. Patrick Lim HIOSSEN Incorporated 85 Ben Fairless Drive Fairless Hills, PA 19030
Re: K132067
Trade/Device Name: Multi Angled Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 31, 2013 Received: November 25, 2013
Dear Mr. Lim:
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.
ff 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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Page 2 - Mr. Lim
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
mer -
for
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DSSTEM Implant Co., Lt #507-8 Geoje3-Dong Yeonje-Gu Busan, Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
Indications for Use
510(k) Number K 132067
... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ..
Device Name : Multi Angled Abutment system
Indication for use : Multi Angled Abutment system is intended for use with a dental implant to provide support for prosthetic restorations such as bridges, or overdentures.
Prescription Use_ X (Per 21CFR801 Subpart D) OR Over-The-Counter Use (Per 21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary Mary S. Runner-5
Susan Run DDS, MA 2013-12-20 08:45:50-05-00
QS-Q1-505-2(Rev.0)
Letter(8.5 X I I in)