(243 days)
No
The summary describes a physical prosthetic system made of standard materials and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device, a Prosthetic System, is intended to provide support for prosthetic restorations. This is a restorative function, not a therapeutic one (treatment or cure of a disease or condition).
No
Explanation: The provided text describes the Prosthetic System's intended use as providing support for prosthetic restorations and its components. It does not mention any function related to diagnosing a condition, disease, or medical problem.
No
The device description explicitly states it is made of physical materials (titanium, titanium alloy, Gold alloy, POM, PC) and consists of physical components (Abutments, Protect caps, Abutment Screws). This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures." This describes a device used in vivo (within the body) to support a physical structure.
- Device Description: The description details the materials and components of a physical prosthetic system used in dentistry.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in a laboratory or clinical setting to analyze biological samples.
Therefore, this device falls under the category of a medical device used for structural support in dental procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
- Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Product codes
NHA
Device Description
-
- The Prosthetic System is device made of titanium, titanium alloy, Gold alloy, POM and PC intended for use as an aid in prosthetic restoration. It consists of Abutments, Protect caps and Abutment Screws. Its surfaces are partially Tin coated and uncoated.
-
- The Prosthetic System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
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
The Fatigue testing for Custom Abutment and Multi Angled Abutment were conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801 Dentistry - Fatigue test for endosseous dental implants. The results are in compliance with it.
No clinical studies are submitted
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.)
0
Image /page/0/Picture/1 description: The image shows the word "OSSTEM" in a stylized font, with the word "IMPLANT" written below it in a smaller font. The letters are black and the background is white. The word "OSSTEM" appears to be a logo or brand name.
TEM Implant Co., L 07-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea el: +82 51 850-2500 Fax: +82 51 850-4341 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 .
Date: January 20, 2011
ОСТ 3 2011
- Company and Correspondent making the submission:
-
Submitter's Name :
-
Address :
OSSTEM Implant Co., Ltd.
#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804, Republic of Korea
82-51-850-2574 - Telephone No. :
Mr. JongHyuk Seo
- Contact :
- Device :
Trade or (Proprietary) Name : Common or usual name : Classification Name :
Prosthetic System Dental Device Abutment, implant, dental, endosseous 21CFR872.3630 Class II NHA
3. Predicate Device :
The HU/HS/HG Prosthetic System, Osstem Implant Co., Ltd, K081575 The HS/HG Prosthetic System, Osstem Implant Co., Ltd, K100245
- Description :
-
- The Prosthetic System is device made of titanium, titanium alloy, Gold alloy, POM and PC intended for use as an aid in prosthetic restoration. It consists of Abutments, Protect caps and Abutment Screws. Its surfaces are partially Tin coated and uncoated.
-
- The Prosthetic System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
QS-QI-505-3(Rev.0)
Letter(8.5 X 11in)
1
Image /page/1/Picture/0 description: The image shows the logo for Osstem Implant. The logo is in a sans-serif font and is black. The word "OSSTEM" is on the top line, and the word "IMPLANT" is on the bottom line. The logo is simple and modern.
2°C
K110308
- Substantial Equivalence Matrix
| Prosthetic System | HU/HS/HG Prosthetic System (K081575) | HS/HG Prosthetic System (K100245) | |
|---|---|---|---|
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd |
| 510(k) | |||
| Number | New | K081575 | K100245 |
| Intended use | Prosthetic System is | ||
| intended for use with a | |||
| dental implant to provide | |||
| support for prosthetic | |||
| restorations such as | |||
| crowns, bridges, or | |||
| overdentures. | HU/HS/HG Prosthetic | ||
| System is intended for | |||
| use with a dental | |||
| implant to provide | |||
| support for prosthetic | |||
| restorations such as | |||
| crowns, bridges, or | |||
| overdentures. | HS/HG Prosthetic | ||
| System is intended for | |||
| use with a dental | |||
| implant to provide | |||
| support for prosthetic | |||
| restorations such as | |||
| crowns, bridges, or | |||
| overdentures. |
5. Indication for use :
Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
6. Review :
The Prosthetic System has similar material, indication for use, design and technological characteristics as the predicate device.
The Prosthetic System has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable international and US regulations.
7. Summary of nonclinical testing
The Fatigue testing for Custom Abutment and Multi Angled Abutment were conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801 Dentistry - Fatigue test for endosseous dental implants. The results are in compliance with it.
-
- Summary of clinical testing No clinical studies are submitted
-
- Conclusion :
Based on the information provided in this premarket notification Osstem concludes that the Prosthetic System is safe and effective and substantially equivalent to the predicate device as described herein.
QS-QI-505-3(Rev.0)
Letter(8.5 X 11in)
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Osstem Implant Company, Limited C/O Mr. Patrick Lim Regulatory Affairs Quality Assurance Manager Hossen, Incorporated 82 Ben Fairless Drive Fairless Hills, Pennsylvania 19030
0CT - 3 2011
Re: K110308
Trade/Device Name: Prosthetic System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 6, 2011 Received: September 7, 2011
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.
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 F-1 feral Register.
3
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 clectronic 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd., a company based in Busan, Republic of Korea. The address is 107-8 Geoje3-Dong Yeonje-Gu Busan, 611-804. The phone number is +82 51 850-2500, the fax number is +82 51 850-4341, and the website is www.osstem.com. There is also a code K110308 and the number 1011 on the right side of the image.
510(k) Number K
Device Name : Prosthetic System
Indication for use : Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, 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)
Sisan Penson
Division Sign-Off) Tivision of Anesthesiology, General Hospital ifection Control, Dental Devices
510(k) Number: K110308
QS-QI-505-2(Rev.0)